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Douglas A Jabs - One of the best experts on this subject based on the ideXlab platform.
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classification criteria for multifocal choroiditis with Panuveitis
American Journal of Ophthalmology, 2021Co-Authors: Douglas A Jabs, Antoine P Brezin, Ralph D Levinson, Peter Mccluskey, Neal Oden, Alan G Palestine, Russell W Read, Jennifer E Thorne, Brett E Trusko, Albert T VitaleAbstract:Purpose To determine classification criteria for multifocal choroiditis with Panuveitis (MFCPU) DESIGN: : Machine learning of cases with MFCPU and 8 other posterior uveitides. Methods Cases of posterior uveitides were collected in an informatics-designed preliminary database, and a final database was constructed of cases achieving supermajority agreement on diagnosis, using formal consensus techniques. Cases were split into a training set and a validation set. Machine learning using multinomial logistic regression was used on the training set to determine a parsimonious set of criteria that minimized the misclassification rate among the posterior uveitides. The resulting criteria were evaluated on the validation set. Results One thousand sixty-eight cases of posterior uveitides, including 138 cases of MFCPU, were evaluated by machine learning. Key criteria for MFCPU included: 1) multifocal choroiditis with the predominant lesions size >125 µm in diameter; 2) lesions outside the posterior pole (with or without posterior involvement); and either 3) punched-out atrophic chorioretinal scars or 4) more than minimal mild anterior chamber and/or vitreous inflammation. Overall accuracy for posterior uveitides was 93.9% in the training set and 98.0% (95% confidence interval 94.3, 99.3) in the validation set. The misclassification rates for MFCPU were 15% in the training set and 0% in the validation set. Conclusions The criteria for MFCPU had a reasonably low misclassification rate and appeared to perform sufficiently well for use in clinical and translational research.
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exudative retinal detachment in ocular inflammatory diseases risk and predictive factors
American Journal of Ophthalmology, 2020Co-Authors: Deepika N Shah, Douglas A Jabs, Stephen C Foster, Jennifer E Thorne, Ahmad Almoujahed, Craig Newcomb, Oktay R Kacmaz, Ebenezer DanielAbstract:Purpose This study evaluated the risk and risk factors for exudative retinal detachment (ERD) in ocular inflammatory diseases. Design Retrospective cohort study. Methods Patients with noninfectious ocular inflammation had been followed longitudinally between 1978 and 2007 at 4 US subspecialty uveitis centers. The main outcome measurements were occurrences of ERD and predictive factors. Results A total of 176 of 14,612 eyes with ocular inflammation presented with ERD. Among uveitis cases, Vogt-Koyanagi-Harada syndrome (VKH) (odds ratio [OR] = 109), undifferentiated choroiditis (OR = 9.18), sympathetic ophthalmia (OR = 8.43), primary or secondary Panuveitis (OR = 7.09), multifocal choroiditis with Panuveitis (OR = 4.51), and “other” forms of posterior uveitis (OR = 16.9) were associated with a higher prevalence of ERD. Among the 9,209 uveitic or scleritic eyes initially free of ERD and followed, 137 incident ERD cases were observed over 28,949 eye-years at risk (incidence rate = 0.47% [0.40%-0.56%/eye-year]). VKH (HR = 13.2), sympathetic ophthalmia (HR = 5.82), undifferentiated choroiditis (HR = 6.03), primary or secondary Panuveitis (HR = 4.21), and rheumatoid arthritis (HR = 3.30) were significantly associated with incident ERD. A significant dose-response relationship with the prevalence and incidence of ERD were observed for AC cells and vitreous cell activity. African Americans had significantly higher prevalence and incidence of ERD. Conclusions Other ocular inflammatory conditions in addition to VKH syndrome and posterior scleritis were associated with increased risk of ERD, indicating that ERD does not necessarily dictate a diagnosis of VKH or posterior scleritis. In addition, the relationship between ERD and inflammatory severity factors implies that inflammation is a key predictive factor associated with developing ERD and requires early and vigorous control.
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factors predicting visual acuity outcome in intermediate posterior and Panuveitis the multicenter uveitis steroid treatment must trial
American Journal of Ophthalmology, 2015Co-Authors: John H Kempen, James P. Dunn, Michael M Altaweel, Douglas A Jabs, Jennifer E Thorne, Mark L Van Natta, Susan Lightman, Janet T HolbrookAbstract:Purpose To identify factors associated with best-corrected visual acuity (BCVA) presentation and 2-year outcome in 479 intermediate, posterior, and panuveitic eyes. Design Cohort study using randomized controlled trial data. Methods Multicenter Uveitis Steroid Treatment (MUST) Trial masked BCVA measurements at baseline and at 2 years follow-up used gold-standard methods. Twenty-three clinical centers documented characteristics per protocol, which were evaluated as potential predictive factors for baseline BCVA and 2-year change in BCVA. Results Baseline factors significantly associated with reduced BCVA included age ≥50 vs 10 vs grade 0; cataract; macular thickening; and exudative retinal detachment. Over 2 years, eyes better than 20/50 and 20/50 or worse at baseline improved, on average, by 1 letter ( P = .52) and 10 letters ( P 10 vs Conclusions Intermediate, posterior, and Panuveitis have a similarly favorable prognosis with both systemic and fluocinolone acetonide implant treatment. Eyes with more prolonged/severe inflammatory damage and/or inflammatory findings initially or during follow-up have a worse visual acuity prognosis. The results indicate the value of implementing best practices in managing inflammation.
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benefits of systemic anti inflammatory therapy versus fluocinolone acetonide intraocular implant for intermediate uveitis posterior uveitis and Panuveitis fifty four month results of the multicenter uveitis steroid treatment must trial and follow up study
Ophthalmology, 2015Co-Authors: John H Kempen, Michael M Altaweel, Janet T Holbrook, Douglas A Jabs, Elizabeth A Sugar, Lea T Drye, Jennifer E ThorneAbstract:PURPOSE To compare the benefits of fluocinolone acetonide implant therapy versus systemic corticosteroid therapy supplemented (when indicated) with immunosuppression for intermediate uveitis, posterior uveitis, and Panuveitis. DESIGN Additional follow-up of a randomized comparative effectiveness trial cohort. PARTICIPANTS Two hundred fifty-five patients with intermediate uveitis, posterior uveitis, or Panuveitis randomized to implant or systemic therapy. MAIN OUTCOME MEASURES Best-corrected visual acuity (BCVA), visual field mean deviation (MD), activity of uveitis, and presence of macular edema (per reading center grading) ascertained prospectively. METHODS Trial participants were followed-up for 54 months from original randomization. RESULTS The visual function trajectory in uveitic eyes demonstrated a similar (P = 0.73) degree of modest (not statistically significant) improvement from baseline to 54 months in both groups (mean improvement in BCVA at 54 months, 2.4 and 3.1 letters in the implant and systemic groups, respectively). Many had excellent initial visual acuity, limiting the potential for improvement. The mean automated perimetry MD score remained similar to baseline throughout 48 months of follow-up in both groups. Overall control of inflammation was superior in the implant group at every time point assessed (P < 0.016), although most eyes in the systemic therapy arm also showed substantial improvement, achieving complete control or low levels of inflammation. Although macular edema improved significantly more often with implant treatment within the first 6 months, the systemic group gradually improved over time such that the proportions with macular edema converged in the 2 groups by 36 months and overlapped thereafter (P = 0.41 at 48 months). CONCLUSIONS Visual outcomes of fluocinolone acetonide implant and systemic treatment for intermediate uveitis, posterior uveitis, and Panuveitis were similarly favorable through 54 months. The implant maintained a clear advantage in controlling inflammation through 54 months. Nevertheless, with systemic therapy, most patients also experienced greatly improved inflammatory status. Macular edema improved equally with longer follow-up. Based on cost effectiveness and side-effect considerations, systemic therapy may be indicated as the initial treatment for many bilateral uveitis cases. However, implant therapy is a reasonable alternative, especially for unilateral cases and when systemic therapy is not feasible or is not successful.
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cost effectiveness of fluocinolone acetonide implant versus systemic therapy for noninfectious intermediate posterior and Panuveitis
Ophthalmology, 2014Co-Authors: Elizabeth A Sugar, John H Kempen, Janet T Holbrook, Douglas A Jabs, Jennifer E Thorne, Lea T Drye, Alyce E Burke, Thomas A LouisAbstract:Objective To evaluate the 3-year incremental cost-effectiveness of fluocinolone acetonide implant versus systemic therapy for the treatment of noninfectious intermediate, posterior, and Panuveitis. Design Randomized, controlled, clinical trial. Participants Patients with active or recently active intermediate, posterior, or Panuveitis enrolled in the Multicenter Uveitis Steroid Treatment Trial. Methods Data on cost and health utility during 3 years after randomization were evaluated at 6-month intervals. Analyses were stratified by disease laterality at randomization (31 unilateral vs 224 bilateral) because of the large upfront cost of the implant. Main Outcome Measures The primary outcome was the incremental cost-effectiveness ratio (ICER) over 3 years: the ratio of the difference in cost (in United States dollars) to the difference in quality-adjusted life-years (QALYs). Costs of medications, surgeries, hospitalizations, and regular procedures (e.g., laboratory monitoring for systemic therapy) were included. We computed QALYs as a weighted average of EQ-5D scores over 3 years of follow-up. Results The ICER at 3 years was $297 800/QALY for bilateral disease, driven by the high cost of implant therapy (difference implant - systemic [Δ]: $16 900; P P = 0.22). The probability of the ICER being cost-effective at thresholds of $50 000/QALY and $100 000/QALY was 0.003 and 0.04, respectively. The ICER for unilateral disease was more favorable, namely, $41 200/QALY at 3 years, because of a smaller difference in cost between the 2 therapies (Δ = $5300; P = 0.44) and a larger benefit in QALYs with the implant (Δ = 0.130; P = 0.12). The probability of the ICER being cost-effective at thresholds of $50 000/QALY and $100 000/QALY was 0.53 and 0.74, respectively. Conclusions Fluocinolone acetonide implant therapy was reasonably cost-effective compared with systemic therapy for individuals with unilateral intermediate, posterior, or Panuveitis but not for those with bilateral disease. These results do not apply to the use of implant therapy when systemic therapy has failed or is contraindicated. Should the duration of implant effect prove to be substantially >3 years or should large changes in therapy pricing occur, the cost-effectiveness of implant versus systemic therapy would need to be reevaluated.
Jennifer E Thorne - One of the best experts on this subject based on the ideXlab platform.
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classification criteria for multifocal choroiditis with Panuveitis
American Journal of Ophthalmology, 2021Co-Authors: Douglas A Jabs, Antoine P Brezin, Ralph D Levinson, Peter Mccluskey, Neal Oden, Alan G Palestine, Russell W Read, Jennifer E Thorne, Brett E Trusko, Albert T VitaleAbstract:Purpose To determine classification criteria for multifocal choroiditis with Panuveitis (MFCPU) DESIGN: : Machine learning of cases with MFCPU and 8 other posterior uveitides. Methods Cases of posterior uveitides were collected in an informatics-designed preliminary database, and a final database was constructed of cases achieving supermajority agreement on diagnosis, using formal consensus techniques. Cases were split into a training set and a validation set. Machine learning using multinomial logistic regression was used on the training set to determine a parsimonious set of criteria that minimized the misclassification rate among the posterior uveitides. The resulting criteria were evaluated on the validation set. Results One thousand sixty-eight cases of posterior uveitides, including 138 cases of MFCPU, were evaluated by machine learning. Key criteria for MFCPU included: 1) multifocal choroiditis with the predominant lesions size >125 µm in diameter; 2) lesions outside the posterior pole (with or without posterior involvement); and either 3) punched-out atrophic chorioretinal scars or 4) more than minimal mild anterior chamber and/or vitreous inflammation. Overall accuracy for posterior uveitides was 93.9% in the training set and 98.0% (95% confidence interval 94.3, 99.3) in the validation set. The misclassification rates for MFCPU were 15% in the training set and 0% in the validation set. Conclusions The criteria for MFCPU had a reasonably low misclassification rate and appeared to perform sufficiently well for use in clinical and translational research.
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exudative retinal detachment in ocular inflammatory diseases risk and predictive factors
American Journal of Ophthalmology, 2020Co-Authors: Deepika N Shah, Douglas A Jabs, Stephen C Foster, Jennifer E Thorne, Ahmad Almoujahed, Craig Newcomb, Oktay R Kacmaz, Ebenezer DanielAbstract:Purpose This study evaluated the risk and risk factors for exudative retinal detachment (ERD) in ocular inflammatory diseases. Design Retrospective cohort study. Methods Patients with noninfectious ocular inflammation had been followed longitudinally between 1978 and 2007 at 4 US subspecialty uveitis centers. The main outcome measurements were occurrences of ERD and predictive factors. Results A total of 176 of 14,612 eyes with ocular inflammation presented with ERD. Among uveitis cases, Vogt-Koyanagi-Harada syndrome (VKH) (odds ratio [OR] = 109), undifferentiated choroiditis (OR = 9.18), sympathetic ophthalmia (OR = 8.43), primary or secondary Panuveitis (OR = 7.09), multifocal choroiditis with Panuveitis (OR = 4.51), and “other” forms of posterior uveitis (OR = 16.9) were associated with a higher prevalence of ERD. Among the 9,209 uveitic or scleritic eyes initially free of ERD and followed, 137 incident ERD cases were observed over 28,949 eye-years at risk (incidence rate = 0.47% [0.40%-0.56%/eye-year]). VKH (HR = 13.2), sympathetic ophthalmia (HR = 5.82), undifferentiated choroiditis (HR = 6.03), primary or secondary Panuveitis (HR = 4.21), and rheumatoid arthritis (HR = 3.30) were significantly associated with incident ERD. A significant dose-response relationship with the prevalence and incidence of ERD were observed for AC cells and vitreous cell activity. African Americans had significantly higher prevalence and incidence of ERD. Conclusions Other ocular inflammatory conditions in addition to VKH syndrome and posterior scleritis were associated with increased risk of ERD, indicating that ERD does not necessarily dictate a diagnosis of VKH or posterior scleritis. In addition, the relationship between ERD and inflammatory severity factors implies that inflammation is a key predictive factor associated with developing ERD and requires early and vigorous control.
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factors predicting visual acuity outcome in intermediate posterior and Panuveitis the multicenter uveitis steroid treatment must trial
American Journal of Ophthalmology, 2015Co-Authors: John H Kempen, James P. Dunn, Michael M Altaweel, Douglas A Jabs, Jennifer E Thorne, Mark L Van Natta, Susan Lightman, Janet T HolbrookAbstract:Purpose To identify factors associated with best-corrected visual acuity (BCVA) presentation and 2-year outcome in 479 intermediate, posterior, and panuveitic eyes. Design Cohort study using randomized controlled trial data. Methods Multicenter Uveitis Steroid Treatment (MUST) Trial masked BCVA measurements at baseline and at 2 years follow-up used gold-standard methods. Twenty-three clinical centers documented characteristics per protocol, which were evaluated as potential predictive factors for baseline BCVA and 2-year change in BCVA. Results Baseline factors significantly associated with reduced BCVA included age ≥50 vs 10 vs grade 0; cataract; macular thickening; and exudative retinal detachment. Over 2 years, eyes better than 20/50 and 20/50 or worse at baseline improved, on average, by 1 letter ( P = .52) and 10 letters ( P 10 vs Conclusions Intermediate, posterior, and Panuveitis have a similarly favorable prognosis with both systemic and fluocinolone acetonide implant treatment. Eyes with more prolonged/severe inflammatory damage and/or inflammatory findings initially or during follow-up have a worse visual acuity prognosis. The results indicate the value of implementing best practices in managing inflammation.
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benefits of systemic anti inflammatory therapy versus fluocinolone acetonide intraocular implant for intermediate uveitis posterior uveitis and Panuveitis fifty four month results of the multicenter uveitis steroid treatment must trial and follow up study
Ophthalmology, 2015Co-Authors: John H Kempen, Michael M Altaweel, Janet T Holbrook, Douglas A Jabs, Elizabeth A Sugar, Lea T Drye, Jennifer E ThorneAbstract:PURPOSE To compare the benefits of fluocinolone acetonide implant therapy versus systemic corticosteroid therapy supplemented (when indicated) with immunosuppression for intermediate uveitis, posterior uveitis, and Panuveitis. DESIGN Additional follow-up of a randomized comparative effectiveness trial cohort. PARTICIPANTS Two hundred fifty-five patients with intermediate uveitis, posterior uveitis, or Panuveitis randomized to implant or systemic therapy. MAIN OUTCOME MEASURES Best-corrected visual acuity (BCVA), visual field mean deviation (MD), activity of uveitis, and presence of macular edema (per reading center grading) ascertained prospectively. METHODS Trial participants were followed-up for 54 months from original randomization. RESULTS The visual function trajectory in uveitic eyes demonstrated a similar (P = 0.73) degree of modest (not statistically significant) improvement from baseline to 54 months in both groups (mean improvement in BCVA at 54 months, 2.4 and 3.1 letters in the implant and systemic groups, respectively). Many had excellent initial visual acuity, limiting the potential for improvement. The mean automated perimetry MD score remained similar to baseline throughout 48 months of follow-up in both groups. Overall control of inflammation was superior in the implant group at every time point assessed (P < 0.016), although most eyes in the systemic therapy arm also showed substantial improvement, achieving complete control or low levels of inflammation. Although macular edema improved significantly more often with implant treatment within the first 6 months, the systemic group gradually improved over time such that the proportions with macular edema converged in the 2 groups by 36 months and overlapped thereafter (P = 0.41 at 48 months). CONCLUSIONS Visual outcomes of fluocinolone acetonide implant and systemic treatment for intermediate uveitis, posterior uveitis, and Panuveitis were similarly favorable through 54 months. The implant maintained a clear advantage in controlling inflammation through 54 months. Nevertheless, with systemic therapy, most patients also experienced greatly improved inflammatory status. Macular edema improved equally with longer follow-up. Based on cost effectiveness and side-effect considerations, systemic therapy may be indicated as the initial treatment for many bilateral uveitis cases. However, implant therapy is a reasonable alternative, especially for unilateral cases and when systemic therapy is not feasible or is not successful.
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cost effectiveness of fluocinolone acetonide implant versus systemic therapy for noninfectious intermediate posterior and Panuveitis
Ophthalmology, 2014Co-Authors: Elizabeth A Sugar, John H Kempen, Janet T Holbrook, Douglas A Jabs, Jennifer E Thorne, Lea T Drye, Alyce E Burke, Thomas A LouisAbstract:Objective To evaluate the 3-year incremental cost-effectiveness of fluocinolone acetonide implant versus systemic therapy for the treatment of noninfectious intermediate, posterior, and Panuveitis. Design Randomized, controlled, clinical trial. Participants Patients with active or recently active intermediate, posterior, or Panuveitis enrolled in the Multicenter Uveitis Steroid Treatment Trial. Methods Data on cost and health utility during 3 years after randomization were evaluated at 6-month intervals. Analyses were stratified by disease laterality at randomization (31 unilateral vs 224 bilateral) because of the large upfront cost of the implant. Main Outcome Measures The primary outcome was the incremental cost-effectiveness ratio (ICER) over 3 years: the ratio of the difference in cost (in United States dollars) to the difference in quality-adjusted life-years (QALYs). Costs of medications, surgeries, hospitalizations, and regular procedures (e.g., laboratory monitoring for systemic therapy) were included. We computed QALYs as a weighted average of EQ-5D scores over 3 years of follow-up. Results The ICER at 3 years was $297 800/QALY for bilateral disease, driven by the high cost of implant therapy (difference implant - systemic [Δ]: $16 900; P P = 0.22). The probability of the ICER being cost-effective at thresholds of $50 000/QALY and $100 000/QALY was 0.003 and 0.04, respectively. The ICER for unilateral disease was more favorable, namely, $41 200/QALY at 3 years, because of a smaller difference in cost between the 2 therapies (Δ = $5300; P = 0.44) and a larger benefit in QALYs with the implant (Δ = 0.130; P = 0.12). The probability of the ICER being cost-effective at thresholds of $50 000/QALY and $100 000/QALY was 0.53 and 0.74, respectively. Conclusions Fluocinolone acetonide implant therapy was reasonably cost-effective compared with systemic therapy for individuals with unilateral intermediate, posterior, or Panuveitis but not for those with bilateral disease. These results do not apply to the use of implant therapy when systemic therapy has failed or is contraindicated. Should the duration of implant effect prove to be substantially >3 years or should large changes in therapy pricing occur, the cost-effectiveness of implant versus systemic therapy would need to be reevaluated.
John H Kempen - One of the best experts on this subject based on the ideXlab platform.
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incidence and outcome of uveitic glaucoma in eyes with intermediate posterior or Panuveitis followed up to 10 years after randomization to fluocinolone acetonide implant or systemic therapy
American Journal of Ophthalmology, 2020Co-Authors: James P. Dunn, John H Kempen, Michael M Altaweel, Janet T Holbrook, Mark L Van Natta, David S Friedman, Husam Ansari, Susan G Elner, Lyndell L LimAbstract:Purpose To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and Panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, “implant”) therapy. Design Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort. Methods Patients with intermediate, posterior, or Panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome. Results Among 405 uveitic at-risk eyes of 232 patients (median follow-up = 6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant on implantation) developed glaucoma (hazard ratio [HR] = 5.9, 95% confidence interval [CI] 3.2, 10.8; P Conclusions The implant has substantially higher risk of glaucoma than systemic therapy, a difference not entirely explained by posttreatment IOP elevation. Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management, some glaucoma worsened. Uveitis cases should be monitored carefully for IOP elevation and glaucoma indefinitely.
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factors predicting visual acuity outcome in intermediate posterior and Panuveitis the multicenter uveitis steroid treatment must trial
American Journal of Ophthalmology, 2015Co-Authors: John H Kempen, James P. Dunn, Michael M Altaweel, Douglas A Jabs, Jennifer E Thorne, Mark L Van Natta, Susan Lightman, Janet T HolbrookAbstract:Purpose To identify factors associated with best-corrected visual acuity (BCVA) presentation and 2-year outcome in 479 intermediate, posterior, and panuveitic eyes. Design Cohort study using randomized controlled trial data. Methods Multicenter Uveitis Steroid Treatment (MUST) Trial masked BCVA measurements at baseline and at 2 years follow-up used gold-standard methods. Twenty-three clinical centers documented characteristics per protocol, which were evaluated as potential predictive factors for baseline BCVA and 2-year change in BCVA. Results Baseline factors significantly associated with reduced BCVA included age ≥50 vs 10 vs grade 0; cataract; macular thickening; and exudative retinal detachment. Over 2 years, eyes better than 20/50 and 20/50 or worse at baseline improved, on average, by 1 letter ( P = .52) and 10 letters ( P 10 vs Conclusions Intermediate, posterior, and Panuveitis have a similarly favorable prognosis with both systemic and fluocinolone acetonide implant treatment. Eyes with more prolonged/severe inflammatory damage and/or inflammatory findings initially or during follow-up have a worse visual acuity prognosis. The results indicate the value of implementing best practices in managing inflammation.
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benefits of systemic anti inflammatory therapy versus fluocinolone acetonide intraocular implant for intermediate uveitis posterior uveitis and Panuveitis fifty four month results of the multicenter uveitis steroid treatment must trial and follow up study
Ophthalmology, 2015Co-Authors: John H Kempen, Michael M Altaweel, Janet T Holbrook, Douglas A Jabs, Elizabeth A Sugar, Lea T Drye, Jennifer E ThorneAbstract:PURPOSE To compare the benefits of fluocinolone acetonide implant therapy versus systemic corticosteroid therapy supplemented (when indicated) with immunosuppression for intermediate uveitis, posterior uveitis, and Panuveitis. DESIGN Additional follow-up of a randomized comparative effectiveness trial cohort. PARTICIPANTS Two hundred fifty-five patients with intermediate uveitis, posterior uveitis, or Panuveitis randomized to implant or systemic therapy. MAIN OUTCOME MEASURES Best-corrected visual acuity (BCVA), visual field mean deviation (MD), activity of uveitis, and presence of macular edema (per reading center grading) ascertained prospectively. METHODS Trial participants were followed-up for 54 months from original randomization. RESULTS The visual function trajectory in uveitic eyes demonstrated a similar (P = 0.73) degree of modest (not statistically significant) improvement from baseline to 54 months in both groups (mean improvement in BCVA at 54 months, 2.4 and 3.1 letters in the implant and systemic groups, respectively). Many had excellent initial visual acuity, limiting the potential for improvement. The mean automated perimetry MD score remained similar to baseline throughout 48 months of follow-up in both groups. Overall control of inflammation was superior in the implant group at every time point assessed (P < 0.016), although most eyes in the systemic therapy arm also showed substantial improvement, achieving complete control or low levels of inflammation. Although macular edema improved significantly more often with implant treatment within the first 6 months, the systemic group gradually improved over time such that the proportions with macular edema converged in the 2 groups by 36 months and overlapped thereafter (P = 0.41 at 48 months). CONCLUSIONS Visual outcomes of fluocinolone acetonide implant and systemic treatment for intermediate uveitis, posterior uveitis, and Panuveitis were similarly favorable through 54 months. The implant maintained a clear advantage in controlling inflammation through 54 months. Nevertheless, with systemic therapy, most patients also experienced greatly improved inflammatory status. Macular edema improved equally with longer follow-up. Based on cost effectiveness and side-effect considerations, systemic therapy may be indicated as the initial treatment for many bilateral uveitis cases. However, implant therapy is a reasonable alternative, especially for unilateral cases and when systemic therapy is not feasible or is not successful.
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cost effectiveness of fluocinolone acetonide implant versus systemic therapy for noninfectious intermediate posterior and Panuveitis
Ophthalmology, 2014Co-Authors: Elizabeth A Sugar, John H Kempen, Janet T Holbrook, Douglas A Jabs, Jennifer E Thorne, Lea T Drye, Alyce E Burke, Thomas A LouisAbstract:Objective To evaluate the 3-year incremental cost-effectiveness of fluocinolone acetonide implant versus systemic therapy for the treatment of noninfectious intermediate, posterior, and Panuveitis. Design Randomized, controlled, clinical trial. Participants Patients with active or recently active intermediate, posterior, or Panuveitis enrolled in the Multicenter Uveitis Steroid Treatment Trial. Methods Data on cost and health utility during 3 years after randomization were evaluated at 6-month intervals. Analyses were stratified by disease laterality at randomization (31 unilateral vs 224 bilateral) because of the large upfront cost of the implant. Main Outcome Measures The primary outcome was the incremental cost-effectiveness ratio (ICER) over 3 years: the ratio of the difference in cost (in United States dollars) to the difference in quality-adjusted life-years (QALYs). Costs of medications, surgeries, hospitalizations, and regular procedures (e.g., laboratory monitoring for systemic therapy) were included. We computed QALYs as a weighted average of EQ-5D scores over 3 years of follow-up. Results The ICER at 3 years was $297 800/QALY for bilateral disease, driven by the high cost of implant therapy (difference implant - systemic [Δ]: $16 900; P P = 0.22). The probability of the ICER being cost-effective at thresholds of $50 000/QALY and $100 000/QALY was 0.003 and 0.04, respectively. The ICER for unilateral disease was more favorable, namely, $41 200/QALY at 3 years, because of a smaller difference in cost between the 2 therapies (Δ = $5300; P = 0.44) and a larger benefit in QALYs with the implant (Δ = 0.130; P = 0.12). The probability of the ICER being cost-effective at thresholds of $50 000/QALY and $100 000/QALY was 0.53 and 0.74, respectively. Conclusions Fluocinolone acetonide implant therapy was reasonably cost-effective compared with systemic therapy for individuals with unilateral intermediate, posterior, or Panuveitis but not for those with bilateral disease. These results do not apply to the use of implant therapy when systemic therapy has failed or is contraindicated. Should the duration of implant effect prove to be substantially >3 years or should large changes in therapy pricing occur, the cost-effectiveness of implant versus systemic therapy would need to be reevaluated.
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the multicenter uveitis steroid treatment trial rationale design and baseline characteristics
American Journal of Ophthalmology, 2010Co-Authors: John H Kempen, Michael M Altaweel, Janet T Holbrook, Douglas A Jabs, Elizabeth A SugarAbstract:PURPOSE: To describe the design and methods of the Multicenter Uveitis Steroid Treatment (MUST) trial and the baseline characteristics of enrolled patients. DESIGN: Baseline data from a 1:1 randomized, parallel treatment design clinical trial at 23 clinical centers comparing systemic corticosteroid therapy (and immunosuppression when indicated) with fluocinolone acetonide implant placement. METHODS: Eligible patients had active or recently active noninfectious intermediate uveitis, posterior uveitis, or Panuveitis. The study design had 90% power (2-sided type I error rate, 0.05) to detect a 7.5-letter (1.5-line) difference between groups in the mean visual acuity change between baseline and 2 years. Secondary outcomes include ocular and systemic complications of therapy and quality of life. Baseline characteristics include demographic and clinical characteristics, quality of life, and reading center gradings of lens and fundus photographs, optical coherence tomography images, and fluorescein angiograms. RESULTS: Over 3 years, 255 patients were enrolled (481 eyes with uveitis). At baseline, 50% of eyes with uveitis had best-corrected visual acuity worse than 20/40 (16% worse than 20/200). Lens opacities (39% of gradeable phakic eyes), macular edema (36%), and epiretinal membrane (48%) were common. Mean health utility was 74.1. CONCLUSIONS: The MUST trial will compare fluocinolone acetonide implant versus systemic therapy for management of intermediate uveitis, posterior uveitis, and Panuveitis. Patients with intermediate uveitis, posterior uveitis, or Panuveitis enrolled in the trial had a high burden of reduced visual acuity, cataract, macular edema, and epiretinal membrane; overall quality of life was lower than expected based on visual acuity.
Janet T Holbrook - One of the best experts on this subject based on the ideXlab platform.
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incidence and outcome of uveitic glaucoma in eyes with intermediate posterior or Panuveitis followed up to 10 years after randomization to fluocinolone acetonide implant or systemic therapy
American Journal of Ophthalmology, 2020Co-Authors: James P. Dunn, John H Kempen, Michael M Altaweel, Janet T Holbrook, Mark L Van Natta, David S Friedman, Husam Ansari, Susan G Elner, Lyndell L LimAbstract:Purpose To evaluate long-term risk and outcomes of glaucoma in eyes with intermediate, posterior, and Panuveitis managed with systemic or fluocinolone acetonide (0.59 mg, “implant”) therapy. Design Prospective Follow-up of the Multicenter Uveitis Steroid Treatment (MUST) Clinical Trial Cohort. Methods Patients with intermediate, posterior, or Panuveitis randomized to implant or systemic therapy (corticosteroid plus immunosuppression in >90%) were followed prospectively for glaucoma incidence and outcome. Results Among 405 uveitic at-risk eyes of 232 patients (median follow-up = 6.9 years), 40% (79/196) of eyes assigned and treated with implant and 8% (17/209) of eyes assigned and treated with systemic therapy (censoring eyes receiving an implant on implantation) developed glaucoma (hazard ratio [HR] = 5.9, 95% confidence interval [CI] 3.2, 10.8; P Conclusions The implant has substantially higher risk of glaucoma than systemic therapy, a difference not entirely explained by posttreatment IOP elevation. Management of IOP elevation was effective in preventing worsening of glaucoma for the large majority of cases, but even under expert clinical management, some glaucoma worsened. Uveitis cases should be monitored carefully for IOP elevation and glaucoma indefinitely.
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factors predicting visual acuity outcome in intermediate posterior and Panuveitis the multicenter uveitis steroid treatment must trial
American Journal of Ophthalmology, 2015Co-Authors: John H Kempen, James P. Dunn, Michael M Altaweel, Douglas A Jabs, Jennifer E Thorne, Mark L Van Natta, Susan Lightman, Janet T HolbrookAbstract:Purpose To identify factors associated with best-corrected visual acuity (BCVA) presentation and 2-year outcome in 479 intermediate, posterior, and panuveitic eyes. Design Cohort study using randomized controlled trial data. Methods Multicenter Uveitis Steroid Treatment (MUST) Trial masked BCVA measurements at baseline and at 2 years follow-up used gold-standard methods. Twenty-three clinical centers documented characteristics per protocol, which were evaluated as potential predictive factors for baseline BCVA and 2-year change in BCVA. Results Baseline factors significantly associated with reduced BCVA included age ≥50 vs 10 vs grade 0; cataract; macular thickening; and exudative retinal detachment. Over 2 years, eyes better than 20/50 and 20/50 or worse at baseline improved, on average, by 1 letter ( P = .52) and 10 letters ( P 10 vs Conclusions Intermediate, posterior, and Panuveitis have a similarly favorable prognosis with both systemic and fluocinolone acetonide implant treatment. Eyes with more prolonged/severe inflammatory damage and/or inflammatory findings initially or during follow-up have a worse visual acuity prognosis. The results indicate the value of implementing best practices in managing inflammation.
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benefits of systemic anti inflammatory therapy versus fluocinolone acetonide intraocular implant for intermediate uveitis posterior uveitis and Panuveitis fifty four month results of the multicenter uveitis steroid treatment must trial and follow up study
Ophthalmology, 2015Co-Authors: John H Kempen, Michael M Altaweel, Janet T Holbrook, Douglas A Jabs, Elizabeth A Sugar, Lea T Drye, Jennifer E ThorneAbstract:PURPOSE To compare the benefits of fluocinolone acetonide implant therapy versus systemic corticosteroid therapy supplemented (when indicated) with immunosuppression for intermediate uveitis, posterior uveitis, and Panuveitis. DESIGN Additional follow-up of a randomized comparative effectiveness trial cohort. PARTICIPANTS Two hundred fifty-five patients with intermediate uveitis, posterior uveitis, or Panuveitis randomized to implant or systemic therapy. MAIN OUTCOME MEASURES Best-corrected visual acuity (BCVA), visual field mean deviation (MD), activity of uveitis, and presence of macular edema (per reading center grading) ascertained prospectively. METHODS Trial participants were followed-up for 54 months from original randomization. RESULTS The visual function trajectory in uveitic eyes demonstrated a similar (P = 0.73) degree of modest (not statistically significant) improvement from baseline to 54 months in both groups (mean improvement in BCVA at 54 months, 2.4 and 3.1 letters in the implant and systemic groups, respectively). Many had excellent initial visual acuity, limiting the potential for improvement. The mean automated perimetry MD score remained similar to baseline throughout 48 months of follow-up in both groups. Overall control of inflammation was superior in the implant group at every time point assessed (P < 0.016), although most eyes in the systemic therapy arm also showed substantial improvement, achieving complete control or low levels of inflammation. Although macular edema improved significantly more often with implant treatment within the first 6 months, the systemic group gradually improved over time such that the proportions with macular edema converged in the 2 groups by 36 months and overlapped thereafter (P = 0.41 at 48 months). CONCLUSIONS Visual outcomes of fluocinolone acetonide implant and systemic treatment for intermediate uveitis, posterior uveitis, and Panuveitis were similarly favorable through 54 months. The implant maintained a clear advantage in controlling inflammation through 54 months. Nevertheless, with systemic therapy, most patients also experienced greatly improved inflammatory status. Macular edema improved equally with longer follow-up. Based on cost effectiveness and side-effect considerations, systemic therapy may be indicated as the initial treatment for many bilateral uveitis cases. However, implant therapy is a reasonable alternative, especially for unilateral cases and when systemic therapy is not feasible or is not successful.
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cost effectiveness of fluocinolone acetonide implant versus systemic therapy for noninfectious intermediate posterior and Panuveitis
Ophthalmology, 2014Co-Authors: Elizabeth A Sugar, John H Kempen, Janet T Holbrook, Douglas A Jabs, Jennifer E Thorne, Lea T Drye, Alyce E Burke, Thomas A LouisAbstract:Objective To evaluate the 3-year incremental cost-effectiveness of fluocinolone acetonide implant versus systemic therapy for the treatment of noninfectious intermediate, posterior, and Panuveitis. Design Randomized, controlled, clinical trial. Participants Patients with active or recently active intermediate, posterior, or Panuveitis enrolled in the Multicenter Uveitis Steroid Treatment Trial. Methods Data on cost and health utility during 3 years after randomization were evaluated at 6-month intervals. Analyses were stratified by disease laterality at randomization (31 unilateral vs 224 bilateral) because of the large upfront cost of the implant. Main Outcome Measures The primary outcome was the incremental cost-effectiveness ratio (ICER) over 3 years: the ratio of the difference in cost (in United States dollars) to the difference in quality-adjusted life-years (QALYs). Costs of medications, surgeries, hospitalizations, and regular procedures (e.g., laboratory monitoring for systemic therapy) were included. We computed QALYs as a weighted average of EQ-5D scores over 3 years of follow-up. Results The ICER at 3 years was $297 800/QALY for bilateral disease, driven by the high cost of implant therapy (difference implant - systemic [Δ]: $16 900; P P = 0.22). The probability of the ICER being cost-effective at thresholds of $50 000/QALY and $100 000/QALY was 0.003 and 0.04, respectively. The ICER for unilateral disease was more favorable, namely, $41 200/QALY at 3 years, because of a smaller difference in cost between the 2 therapies (Δ = $5300; P = 0.44) and a larger benefit in QALYs with the implant (Δ = 0.130; P = 0.12). The probability of the ICER being cost-effective at thresholds of $50 000/QALY and $100 000/QALY was 0.53 and 0.74, respectively. Conclusions Fluocinolone acetonide implant therapy was reasonably cost-effective compared with systemic therapy for individuals with unilateral intermediate, posterior, or Panuveitis but not for those with bilateral disease. These results do not apply to the use of implant therapy when systemic therapy has failed or is contraindicated. Should the duration of implant effect prove to be substantially >3 years or should large changes in therapy pricing occur, the cost-effectiveness of implant versus systemic therapy would need to be reevaluated.
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the multicenter uveitis steroid treatment trial rationale design and baseline characteristics
American Journal of Ophthalmology, 2010Co-Authors: John H Kempen, Michael M Altaweel, Janet T Holbrook, Douglas A Jabs, Elizabeth A SugarAbstract:PURPOSE: To describe the design and methods of the Multicenter Uveitis Steroid Treatment (MUST) trial and the baseline characteristics of enrolled patients. DESIGN: Baseline data from a 1:1 randomized, parallel treatment design clinical trial at 23 clinical centers comparing systemic corticosteroid therapy (and immunosuppression when indicated) with fluocinolone acetonide implant placement. METHODS: Eligible patients had active or recently active noninfectious intermediate uveitis, posterior uveitis, or Panuveitis. The study design had 90% power (2-sided type I error rate, 0.05) to detect a 7.5-letter (1.5-line) difference between groups in the mean visual acuity change between baseline and 2 years. Secondary outcomes include ocular and systemic complications of therapy and quality of life. Baseline characteristics include demographic and clinical characteristics, quality of life, and reading center gradings of lens and fundus photographs, optical coherence tomography images, and fluorescein angiograms. RESULTS: Over 3 years, 255 patients were enrolled (481 eyes with uveitis). At baseline, 50% of eyes with uveitis had best-corrected visual acuity worse than 20/40 (16% worse than 20/200). Lens opacities (39% of gradeable phakic eyes), macular edema (36%), and epiretinal membrane (48%) were common. Mean health utility was 74.1. CONCLUSIONS: The MUST trial will compare fluocinolone acetonide implant versus systemic therapy for management of intermediate uveitis, posterior uveitis, and Panuveitis. Patients with intermediate uveitis, posterior uveitis, or Panuveitis enrolled in the trial had a high burden of reduced visual acuity, cataract, macular edema, and epiretinal membrane; overall quality of life was lower than expected based on visual acuity.
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the collaborative ocular tuberculosis study cots 1 a multinational review of 447 patients with tubercular intermediate uveitis and Panuveitis
Ocular Immunology and Inflammation, 2020Co-Authors: Rupesh Agrawal, Aniruddha Agarwal, Bjorn Kaijun Betzler, Ilaria Testi, Sarakshi Mahajan, Dinesh Visva Gunasekeran, Dhananjay Raje, Kanika Aggarwal, Somasheila I Murthy, Mark WestcottAbstract:Purpose: Tubercular intermediate uveitis (TIU) and Panuveitis (TBP) are difficult to manage because of limitations in diagnostic tools and lack of evidence-based treatment guidelines. The Collabora...
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choroidal vascularity index cvi a novel optical coherence tomography parameter for monitoring patients with Panuveitis
PLOS ONE, 2016Co-Authors: Rupesh Agrawal, Mohammed Salman, Karaanne Tan, Michael Karampelas, Dawn A Sim, Pearse A KeaneAbstract:Purpose To compute choroidal vascularity index (CVI) using an image binarization tool on enhanced depth imaging (EDI)-optical coherence tomography (OCT) scans as a non-invasive optical tool to monitor progression in Panuveitis and to investigate the utility of volumetric data from EDI-OCT scans using custom image analysis software. Materials and Methods In this retrospective cohort study, segmented EDI-OCT scans of both eyes in 19 patients with Panuveitis were taken at baseline and at 3-month follow-up and were compared with EDI-OCT scans of normal eyes. Subfoveal choroidal area was segmented into luminal (LA) and stromal interstitial area (SA). Choroidal vascularity index (CVI) was defined as the proportion of LA to the total circumscribed subfoveal choroidal area (TCA). Results The mean choroidal thickness was 265.5±100.1μm at baseline and 278.4±102.6μm at 3 months follow up (p = 0.06). There was no statistically significant difference in TCA between study and control eyes (p = 0.08). CVI in the control group was 66.9±1.5% at baseline and 66.4±1.5% at follow up. CVI was 74.1±4.7% at baseline and 69.4±4.8% at 3 months follow up for uveitic eyes (p<0.001). The % change in CVI was 6.2 ±3.8 (4.3 to 8.0) for uveitic eyes, which was significantly higher from % change in CVI for control eyes (0.7±1.1, 0.2 to 1.3, p<0.001). Conclusion The study reports composite OCT-derived parameters and CVI as a possible novel tool in monitoring progression in Panuveitis. CVI may be further validated in larger studies as a novel optical tool to quantify choroidal vascular status.
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a case of Panuveitis with hypopyon due to presumed ocular leishmaniasis in a hiv patient
Journal of Ophthalmic Inflammation and Infection, 2014Co-Authors: Rupesh Agrawal, Simon Couture, Kate Woods, Diana N J Lockwood, Carlos Pavesio, Peter K F AddisonAbstract:Post-kala-azar dermal leishmaniasis is a well-known immunologic cutaneous reaction. There are few case reports of ocular leishmaniasis. It is a sight-threatening condition that needs to be rapidly recognized and treated to avoid permanent visual loss. Ocular leishmaniasis Panuveitis can present with severe inflammation in patients with highly active anti-retroviral therapy (HAART)-induced immune reconstitution syndrome. A case of a 40-year-old man, human immunodeficiency virus (HIV) positive on HAART, with a presumed diagnosis of ocular leishmaniasis, is presented. He had a past history of visceral leishmaniasis and was referred to the uveitis service with rapidly worsening Panuveitis and counting fingers vision in both eyes. On empirical anti-leishmania therapy and systemic steroids, the visual acuity of the left eye improved to 6/9 but remained poor in the right eye. Based on the medical history, improvement with therapy and the exclusion of other common infections, a presumed diagnosis of ocular leishmaniasis-related Panuveitis was made. A major immune reaction against lingering parasites may play a key role in the pathogenesis of this sight-threatening and rapidly progressive condition. Both the infection and the immune reaction should be treated.
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a case of Panuveitis with hypopyon due to presumed ocular leishmaniasis in a hiv patient
Journal of Ophthalmic Inflammation and Infection, 2014Co-Authors: Rupesh Agrawal, Simon Couture, Kate Woods, Diana N J Lockwood, Carlos Pavesio, Peter K F AddisonAbstract:Background Post-kala-azar dermal leishmaniasis is a well-known immunologic cutaneous reaction. There are few case reports of ocular leishmaniasis. It is a sight-threatening condition that needs to be rapidly recognized and treated to avoid permanent visual loss. Ocular leishmaniasis Panuveitis can present with severe inflammation in patients with highly active anti-retroviral therapy (HAART)-induced immune reconstitution syndrome.
