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Timothy L Comstock - One of the best experts on this subject based on the ideXlab platform.
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use of the fluocinolone acetonide intravitreal implant for the treatment of noninfectious Posterior Uveitis 3 year results of a randomized clinical trial in a predominantly asian population
Ophthalmology and therapy, 2015Co-Authors: Virender S Sangwan, Andrew P Pearson, Hemanth Paul, Timothy L ComstockAbstract:Introduction The fluocinolone acetonide (FA) intravitreal implant 0.59 mg (Retisert®, Bausch + Lomb, Rochester, NY, USA) provides sustained release of FA directly to the vitreous cavity over a prolonged period of time. The purpose of this study was to evaluate the safety and efficacy of a 0.59- and 2.1-mg FA intravitreal implant in patients with noninfectious Posterior Uveitis.
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for the Fluocinolone
2013Co-Authors: Quan Dong Nguyen, Timothy L Comstock, Dale W Usner, Acetonide Uveitis Study, Correspondence JohnAbstract:Post-cataract outcomes in patients with noninfectious Posterior Uveitis treated with the fluocinolone acetonide intravitreal implan
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post cataract outcomes in patients with noninfectious Posterior Uveitis treated with the fluocinolone acetonide intravitreal implant
Clinical Ophthalmology, 2012Co-Authors: John D Sheppard, Quan Dong Nguyen, Dale W Usner, Timothy L ComstockAbstract:Purpose To describe visual acuity (VA) and inflammation following cataract surgery in eyes with noninfectious Posterior Uveitis (NIPU) that were being treated with a fluocinolone acetonide (FA) intravitreal implant compared with those that were not.
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evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious Posterior Uveitis
Ophthalmology, 2010Co-Authors: Carlos Pavesio, Timothy L Comstock, Manfred Zierhut, Khaled Bairi, Dale W UsnerAbstract:Purpose To evaluate the safety and efficacy of an intravitreal fluocinolone acetonide (FA) implant compared with standard therapy in subjects with noninfectious Posterior Uveitis (NIPU). Design Randomized, controlled, phase 2b/3, open-label, multicenter superiority trial. Participants Subjects with unilateral or bilateral NIPU. Methods One hundred forty subjects received either a 0.59-mg FA intravitreal implant (n = 66) or standard of care (SOC; n=74) with either systemic prednisolone or equivalent corticosteroid as monotherapy (≥0.2 mg/kg daily) or, if judged necessary by the investigator, combination therapy with an immunosuppressive agent plus a lower dose of prednisolone or equivalent corticosteroid (≥0.1 mg/kg daily). Main Outcome Measures Time to first recurrence of Uveitis. Results Eyes that received the FA intravitreal implant experienced delayed onset of observed recurrence of Uveitis ( P P ≤0.01) compared with SOC study eyes. Adverse events frequently observed in implanted eyes included elevated intraocular pressure (IOP) requiring IOP-lowering surgery (occurring in 21.2% of implanted eyes) and cataracts requiring extraction (occurring in 87.8% of phakic implanted eyes). No treatment-related nonocular adverse events were observed in the implant group, whereas such events occurred in 25.7% of subjects in the SOC group. Conclusions The FA intravitreal implant provided better control of inflammation in patients with Uveitis compared with systemic therapy. Intraocular pressure and lens clarity of implanted eyes need close monitoring in patients receiving the FA intravitreal implant. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.
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treatment of Posterior Uveitis with a fluocinolone acetonide implant three year clinical trial results
Archives of Ophthalmology, 2008Co-Authors: David Callanan, Glenn J Jaffe, Daniel F Martin, P A Pearson, Timothy L ComstockAbstract:Objectives: To evaluate the safety and efficacy of 0.59-mg and 2.1-mg fluocinolone acetonide (FA) intravitreous implants in noninfectious Posterior Uveitis. Design: A 3-year, multicenter, randomized, historically controlled trial of the 0.59-mg FA intravitreous implant in 110 patients and the 2.1-mg FA intravitreous implant in 168 patients. Main Outcome Measures: Recurrence rate, vision, and complications. Results: Uveitis recurrence was reduced in implanted eyes from 62% (during the 1-year preimplantation period) to 4%, 10%, and 20% during the 1-, 2-, and 3-year postimplantation periods, respectively, for the 0.59-mg dose group (P<.01) and from 58% to 7%, 17%, and 41%, respectively, for the 2.1-mg dose group (P<.01). More implanted eyes than nonimplanted eyes had improved visual acuity (P<.01). Implanted eyes had higher incidences of intraocular pressure elevation (≥ 10 mm Hg) than nonimplanted eyes (P<.01), and glaucoma surgery was required in 40% of implanted eyes vs 2% of nonimplanted eyes (P <. 01). Cataracts were extracted in 93% of phakic implanted eyes vs 20% of phakic nonimplanted eyes (P<.01). Conclusions: The FA implant significantly reduced Uveitis recurrence and improved or stabilized visual acuity in subjects with noninfectious Posterior Uveitis. Most subjects required cataract extraction, and a significant proportion required intraocular pressure-lowering surgery. Application to Clinical Practice: The FA implant provides an alternative therapy for prolonged control of inflammation in noninfectious Posterior Uveitis.
Jennifer E Thorne - One of the best experts on this subject based on the ideXlab platform.
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effectiveness of the dexamethasone implant in lieu of oral corticosteroids in intermediate and Posterior Uveitis requiring immunosuppression
Ocular Immunology and Inflammation, 2020Co-Authors: Meghan K Berkenstock, Jennifer E Thorne, Tahreem A Mir, Irfan R Khan, Bryn M Burkholder, Benjamin C Chaon, Amde Selassie ShiferaAbstract:To evaluate dexamethasone intravitreal implant effectiveness in lieu of high-dose oral prednisone for short-term treatment of noninfectious intermediate and Posterior Uveitis in patients requiring ...
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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
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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risk of choroidal neovascularization among the uveitides
American Journal of Ophthalmology, 2013Co-Authors: Sally L Baxter, Douglas A Jabs, Jennifer E Thorne, Maxwell Pistilli, Siddharth S Pujari, Teresa L Liesegang, Eric B SuhlerAbstract:Purpose To evaluate the risk, risk factors, and visual impact of choroidal neovascularization (CNV) in Uveitis cases. Design Retrospective cohort study. Methods Standardized medical record review at 5 tertiary centers. Results Among 15 137 uveitic eyes (8868 patients), CNV was rare in the cases of anterior or intermediate Uveitis. Among the 4041 eyes (2307 patients) with Posterior Uveitis or panUveitis, 81 (2.0%) had CNV at presentation. Risk factors included Posterior Uveitis in general and specific Uveitis syndromes affecting the outer retina–retinal pigment epithelium–choroid interface. Among the 2364 eyes (1357 patients) with Posterior Uveitis or panUveitis and free of CNV at the time of cohort entry, the cumulative 2-year incidence of CNV was 2.7% (95% confidence interval [CI], 1.8% to 3.5%). Risk factors for incident CNV included currently active inflammation (adjusted hazard ratio [aHR], 2.13; 95% CI, 1.26 to 3.60), preretinal neovascularization (aHR, 3.19; 95% CI, 1.30 to 7.80), and prior diagnosis of CNV in the contralateral eye (aHR, 5.79; 95% CI, 2.77 to 12.09). Among specific syndromes, the incidence was greater in Vogt-Koyanagi-Harada syndrome (aHR, 3.37; 95% CI, 1.52 to 7.46) and punctate inner choroiditis (aHR, 8.67; 95% CI, 2.83 to 26.54). Incident CNV was associated with a 2-line loss of visual acuity (+0.19 logarithm of the minimal angle of resolution units; 95% CI, 0.079 to 0.29) from the preceding visit. Conclusions CNV is an uncommon complication of Uveitis associated with visual impairment that occurs more commonly in forms affecting the outer retina–retinal pigment epithelium–choroid interface, during periods of inflammatory activity, in association with preretinal neovascularization, and in second eyes of patients with unilateral CNV. Because CNV is treatable, a systematic approach to early detection in high-risk patients may be appropriate.
Glenn J Jaffe - One of the best experts on this subject based on the ideXlab platform.
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effect of an injectable fluocinolone acetonide insert on recurrence rates in chronic noninfectious Uveitis affecting the Posterior segment twelve month results
Ophthalmology, 2019Co-Authors: Glenn J Jaffe, Carlos Pavesio, Stephen C Foster, Dario A Paggiarino, Gerard E RiedelAbstract:Purpose To assess the safety and efficacy of an intravitreal fluocinolone acetonide (FA) insert to manage inflammation associated with chronic noninfectious Posterior Uveitis. Design Multicenter, randomized, prospective, doubled-masked, sham-controlled, 3-year phase 3 clinical trial. Participants One hundred twenty-nine participants with recurrent noninfectious Posterior Uveitis were assigned randomly to FA insert (n = 87) or sham injection (n = 42). The more severely affected eye in participants with bilateral disease was designated as the study eye. Methods The insert (FA, 0.18 mg) was injected into the vitreous cavity; sham injection mimicked the insert delivery procedure. Ophthalmic examinations, OCT, and ocular tolerability and discomfort assessments were conducted; study visits were on days 7 and 28 and months 2, 3, 6, 9, and 12. Uveitis recurrence was treated as needed. The 6-month recurrence rate was the primary outcome measure. Results The 6-month (28% and 91%) and 12-month (38% and 98%) Uveitis recurrence rates were significantly lower (P Conclusions Chronic noninfectious Posterior Uveitis was managed successfully in this study population; FA insert eyes experienced fewer Uveitis recurrence episodes, required fewer adjunctive treatments, and demonstrated less visual acuity loss compared with sham eyes. The FA insert treatment group showed higher rates of cataract; delivery by injection was not associated with an increase in ocular adverse events or any other safety measures not typically associated with local steroid use, suggesting the procedure is appropriate for an office setting.
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injectable fluocinolone acetonide long acting implant for noninfectious intermediate Uveitis Posterior Uveitis and panUveitis two year results
Ophthalmology, 2016Co-Authors: Glenn J Jaffe, Paul Ashton, Cindy Skalak, Phoebe Lin, Robert T Keenan, Sandra S StinnettAbstract:Purpose To determine the effect of an injectable fluocinolone acetonide implant (FAi) in eyes with noninfectious intermediate Uveitis, Posterior Uveitis, or panUveitis. Design Noncomparative, interventional, dose-randomized, dose-masked, prospective, individual, investigator-sponsored investigational new drug study. Participants Eleven eyes of 11 participants with a history of recurrent noninfectious intermediate Uveitis, Posterior, or panUveitis. Methods Participants were randomized to receive either a low- or a high-dose FAi. Eyes were observed on day 0 (day the implant was injected) and then at regular intervals through 2 years. Main Outcome Measures Ocular inflammation, visual acuity, anti-inflammatory medication use, and safety parameters before and after FAi implantation. Results All participants were followed up for 2 years. At baseline, mean study eye visual acuity was 0.56 logarithm of the minimum angle of resolution (logMAR; standard deviation [SD], 0.43 logMAR). These values improved significantly to +0.25 logMAR (SD, 0.14 logMAR) and +0.17 logMAR (SD, 0.14 logMAR) at 12 and 24 months after implantation, respectively ( P = 0.041 and P = 0.016, respectively). The average number of inflammation recurrences in the 12 months before implantation was 1.54 episodes per eye. None of the study eyes experienced a recurrence during the follow-up period. Of the 6 participants who continued receiving systemic medication after implantation, the dosage was reduced in 4 participants. Five of 11 eyes received an average of 1.6 Posterior sub-Tenon triamcinolone acetonide (PSTA) injections in the 12 months preceding implantation. None required a PSTA injection after FAi implantation. The most common adverse event was intraocular pressure (IOP) rise. At baseline, 1 study eye (9%) required pressure-lowering drops; 2 additional study eyes (18%) required them during the follow-up period. Filtering procedures were performed in 2 of these eyes (18.1%). No FAi explantations were required, nor were any participants lost to follow-up during the investigation. Conclusions It is feasible to place a long-acting FAi in an outpatient setting, without prolonged adverse events attributed to the implant injection procedure. The FAi effectively controlled intraocular inflammation in all eyes in the study, and at the last follow-up, all implanted eyes demonstrated an improvement in visual acuity. Elevated IOP that occurred in 18% of FAi-implanted eyes was managed by standard means. The FAi implant is a promising approach for patients with noninfectious intermediate Uveitis, Posterior Uveitis, or panUveitis who do not respond to, or are intolerant to, conventional therapy.
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treatment of Posterior Uveitis with a fluocinolone acetonide implant three year clinical trial results
Archives of Ophthalmology, 2008Co-Authors: David Callanan, Glenn J Jaffe, Daniel F Martin, P A Pearson, Timothy L ComstockAbstract:Objectives: To evaluate the safety and efficacy of 0.59-mg and 2.1-mg fluocinolone acetonide (FA) intravitreous implants in noninfectious Posterior Uveitis. Design: A 3-year, multicenter, randomized, historically controlled trial of the 0.59-mg FA intravitreous implant in 110 patients and the 2.1-mg FA intravitreous implant in 168 patients. Main Outcome Measures: Recurrence rate, vision, and complications. Results: Uveitis recurrence was reduced in implanted eyes from 62% (during the 1-year preimplantation period) to 4%, 10%, and 20% during the 1-, 2-, and 3-year postimplantation periods, respectively, for the 0.59-mg dose group (P<.01) and from 58% to 7%, 17%, and 41%, respectively, for the 2.1-mg dose group (P<.01). More implanted eyes than nonimplanted eyes had improved visual acuity (P<.01). Implanted eyes had higher incidences of intraocular pressure elevation (≥ 10 mm Hg) than nonimplanted eyes (P<.01), and glaucoma surgery was required in 40% of implanted eyes vs 2% of nonimplanted eyes (P <. 01). Cataracts were extracted in 93% of phakic implanted eyes vs 20% of phakic nonimplanted eyes (P<.01). Conclusions: The FA implant significantly reduced Uveitis recurrence and improved or stabilized visual acuity in subjects with noninfectious Posterior Uveitis. Most subjects required cataract extraction, and a significant proportion required intraocular pressure-lowering surgery. Application to Clinical Practice: The FA implant provides an alternative therapy for prolonged control of inflammation in noninfectious Posterior Uveitis.
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fluocinolone acetonide implant retisert for noninfectious Posterior Uveitis thirty four week results of a multicenter randomized clinical study
Ophthalmology, 2006Co-Authors: Glenn J Jaffe, David Callanan, Daniel F Martin, Andrew P Pearson, Brian Levy, Timothy L ComstockAbstract:Purpose To report the interim 34-week safety and efficacy results of a 3-year study to evaluate an investigational intravitreal fluocinolone acetonide (FA) implant in patients with noninfectious Posterior Uveitis. Design Prospective, dose-masked, dose-randomized, historically controlled, multicenter trial in patients with unilateral or bilateral disease. Participants A total of 278 patients with recurrent noninfectious Posterior Uveitis were randomized to receive a 0.59-mg (n = 110) or 2.1-mg (n = 168) implant. In patients with bilateral disease, the more severely affected eye received the implant. Methods The implant was inserted surgically into the vitreous cavity through a pars plana incision. Follow-up visits were scheduled on day 2, week 1, and then every 4 to 6 weeks through 34 weeks after implantation. Systemic, periocular, and topical therapies were reduced as allowed by the clinical response. Main Outcome Measures The primary efficacy outcome was a comparison of the recurrence rate in the implanted eye from the 34 weeks before implantation to the 34 weeks after implantation. Visual acuity (VA), need for adjunctive therapy, and safety also were assessed. Results Combining both doses, the FA implant reduced the rate of recurrences from 51.4% in the 34 weeks preceding implantation to 6.1% postimplantation ( P P P ≤0.0001 in all cases). At week 34, 51.1% of implanted eyes required ocular antihypertensive drops, and 5.8% underwent glaucoma filtering surgery. Lens opacity scores increased by ≥2 grades in 19.8% of phakic implanted eyes, and 9.9% required cataract surgery. There were no statistically significant differences in any of the parameters studied for the 0.59-mg implant, compared with the 2.1-mg implant. Conclusions The FA implant significantly reduced Uveitis recurrences, improved VA, and decreased the need for adjunctive therapy in the studied patient population. The most common side effects included increased intraocular pressure and cataract progression.
Douglas A Jabs - One of the best experts on this subject based on the ideXlab platform.
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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
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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risk of choroidal neovascularization among the uveitides
American Journal of Ophthalmology, 2013Co-Authors: Sally L Baxter, Douglas A Jabs, Jennifer E Thorne, Maxwell Pistilli, Siddharth S Pujari, Teresa L Liesegang, Eric B SuhlerAbstract:Purpose To evaluate the risk, risk factors, and visual impact of choroidal neovascularization (CNV) in Uveitis cases. Design Retrospective cohort study. Methods Standardized medical record review at 5 tertiary centers. Results Among 15 137 uveitic eyes (8868 patients), CNV was rare in the cases of anterior or intermediate Uveitis. Among the 4041 eyes (2307 patients) with Posterior Uveitis or panUveitis, 81 (2.0%) had CNV at presentation. Risk factors included Posterior Uveitis in general and specific Uveitis syndromes affecting the outer retina–retinal pigment epithelium–choroid interface. Among the 2364 eyes (1357 patients) with Posterior Uveitis or panUveitis and free of CNV at the time of cohort entry, the cumulative 2-year incidence of CNV was 2.7% (95% confidence interval [CI], 1.8% to 3.5%). Risk factors for incident CNV included currently active inflammation (adjusted hazard ratio [aHR], 2.13; 95% CI, 1.26 to 3.60), preretinal neovascularization (aHR, 3.19; 95% CI, 1.30 to 7.80), and prior diagnosis of CNV in the contralateral eye (aHR, 5.79; 95% CI, 2.77 to 12.09). Among specific syndromes, the incidence was greater in Vogt-Koyanagi-Harada syndrome (aHR, 3.37; 95% CI, 1.52 to 7.46) and punctate inner choroiditis (aHR, 8.67; 95% CI, 2.83 to 26.54). Incident CNV was associated with a 2-line loss of visual acuity (+0.19 logarithm of the minimal angle of resolution units; 95% CI, 0.079 to 0.29) from the preceding visit. Conclusions CNV is an uncommon complication of Uveitis associated with visual impairment that occurs more commonly in forms affecting the outer retina–retinal pigment epithelium–choroid interface, during periods of inflammatory activity, in association with preretinal neovascularization, and in second eyes of patients with unilateral CNV. Because CNV is treatable, a systematic approach to early detection in high-risk patients may be appropriate.
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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.
Andrew D Dick - One of the best experts on this subject based on the ideXlab platform.
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effect of adalimumab on visual functioning in patients with noninfectious intermediate Uveitis Posterior Uveitis and panUveitis in the visual 1 and visual 2 trials
JAMA Ophthalmology, 2017Co-Authors: John D Sheppard, Avani Joshi, Keith A Betts, Stacie Hudgens, Samir R Tari, N Chen, Martha Skup, Andrew D DickAbstract:Importance Adalimumab was recently approved for the treatment of noninfectious intermediate Uveitis, Posterior Uveitis, and panUveitis. Objective To assess the effect of adalimumab on the visual functioning and quality of life in patients with corticosteroid-dependent noninfectious intermediate Uveitis, Posterior Uveitis, and panUveitis. Design A post hoc analysis of clinical trials of adults with active (VISUAL-1) and inactive (VISUAL-2) noninfectious intermediate Uveitis, Posterior Uveitis, and panUveitis was conducted in the United States, Canada, Europe, Israel, Australia, Latin America, and Japan. A total of 217 patients (110 adalimumab, 107 placebo) in VISUAL-1 and 226 patients (115 adalimumab, 111 placebo) in VISUAL-2 were studied using intent-to-treat analyses. The clinical trials were conducted between August 10, 2010, and May 14, 2015. Interventions In VISUAL-1 and VISUAL-2, patients were randomized to receive adalimumab, 80-mg, subcutaneous loading dose followed by 40 mg every other week or placebo for 80 weeks. All patients underwent prednisone tapering, with patients in VISUAL-1 receiving an initial prednisone burst. Main Outcomes and Measures The 25-item National Eye Institute Vision Function Questionnaire (NEI VFQ-25) composite score questionnaire assessed the impact of visual impairment from the patient’s perspective; scores on the questionnaire range from 0 to 100, with higher scores indicating better vision-related quality of life. The change in NEI VFQ-25 from best state achieved prior to week 6 (VISUAL-1) and from baseline state (VISUAL-2) to the final or early termination visit was determined in each group and statistically compared using analysis of variance. The temporal effects of adalimumab and placebo on NEI VFQ-25 were investigated using a longitudinal model. Results Of the 217 patients in VISUAL-1, 124 (57.1%) were women; the mean (SD) age was 42.7 (14.9) years. Of the 226 patients in VISUAL-2, 138 (61.1%) were women; the mean (SD) age was 42.5 (13.4). In VISUAL-1, the change from final score to best score in NEI VFQ-25 was −1.30 for adalimumab and −5.50 for placebo—a difference of 4.20 (95% CI, 1.04 to 7.36; P = .01) associated with adalimumab compared with placebo. In VISUAL-2, the change from baseline NEI VFQ-25 was 3.36 for adalimumab and 1.24 for placebo—a difference of 2.12 (95% CI, −0.81 to 5.04; P = .16). In both trials, the longitudinal models showed a significant difference in NEI VFQ-25 between adalimumab and placebo of 3.07 (95% CI, 2.09 to 4.06; P P = .048) in the VISUAL-1 (74.15 vs 71.08) and VISUAL-2 (82.39 vs 77.73) trials, respectively. Conclusions and Relevance This post hoc analysis suggests that adalimumab is associated with statistically significant and clinically meaningful improvements in patient-reported visual functioning for patients with noninfectious intermediate Uveitis, Posterior Uveitis, and panUveitis. Trial Registration clinicaltrials.gov Identifiers:NCT01138657(VISUAL-1) andNCT01124838(VISUAL-2)
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risk of ocular complications in patients with noninfectious intermediate Uveitis Posterior Uveitis or panUveitis
Ophthalmology, 2016Co-Authors: Andrew D Dick, Avani Joshi, Namita Tundia, Rachael Sorg, Chen Zhao, Jingdong Chao, Martha SkupAbstract:Purpose Noninfectious Uveitis results in vision loss and ocular complications without adequate treatment. We compared the risk of developing ocular complications between patients with noninfectious intermediate Uveitis, Posterior Uveitis, or panUveitis (NIIPPU) and matched controls. Design Retrospective analysis of insurance claims data (OptumHealth, Eden Prairie, MN; January 1, 1998–March 31, 2012). Participants Cases 18 to 64 years of age with 2 or more NIIPPU diagnoses (International Classification of Diseases, 9th Revision, Clinical Modification codes) were matched 1:1 by sex, age, region, company, employment status, and index date with controls without Uveitis. Patients with an ocular complication during baseline were excluded. Methods Continuous eligibility for 6 months or more before the first NIIPPU diagnosis date was required. Risks of ocular complications developing during patients' continuous eligibility in the study period were compared using unadjusted Kaplan-Meier survival analysis to estimate risk of and time to complications and adjusted Cox regression analysis to estimate hazard ratios (HRs). Main Outcome Measures Percentages of cases and controls who demonstrate ocular complications and 1-, 5-, and 10-year risks and HRs for each complication. Results Mean age of the 1769 cases and matched controls was 47 years and 47% were men; 302 cases had persistent NIIPPU. During the study period, NIIPPU cases had a higher risk of any ocular complication ( P P Conclusions Noninfectious intermediate Uveitis, Posterior Uveitis, or panUveitis, particularly persistent disease, is associated with a substantial risk of ocular complications. Optimal treatment initiatives remain imperative to reduce the ocular complication–related burden of NIIPPU.
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inflammatory choroidal neovascular membrane in Posterior Uveitis pathogenesis and treatment
Indian Journal of Ophthalmology, 2010Co-Authors: Narendra Dhingra, Susan Kelly, Mohammed A Majid, Claire Bailey, Andrew D DickAbstract:Choroidal neovascular membrane (CNVM) formation is a well-documented sight-threatening complication of Posterior segment intraocular inflammation (PSII). The aim of this article is to review the basic and clinical science literature on the pathogenesis of CNVM formation in PSII and to present results of a case series. We searched the literature using the mesh terms- inflammation, CNVM, age-related macular degeneration, immunosuppression, photodynamic therapy, steroids, vascular endothelial growth factors and Posterior Uveitis. Additionally, we evaluated the visual outcome of and clinical response to our standard treatment protocol involving a combination treatment for young patients with inflammatory CNVM. The development of CNVM in PSII is promulgated by infiltrating myeloid cells as well as choroidal and retinal myeloid cell activation, subsequent vascular endothelial growth factors, cytokine and chemokine production and complement activation acting in consort to mediate angiogenic responses. No clear standard of care currently exists for the treatment of inflammatory CNVM and various combinations have been tried. Using our combination treatment, visual acuity improved in four, stabilized in one and worsened in four patients. Though significant advances have occurred in the understanding of the pathogenesis and management of this condition, optimizing therapeutic regimens will require further well-constructed prospective cohort series.
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The B subunit of Escherichia coli heat-labile enterotoxin inhibits Th1 but not Th17 cell responses in established experimental autoimmune uveoretinitis.
Investigative ophthalmology & visual science, 2008Co-Authors: Ben J. E. Raveney, David A. Copland, C. M. Richards, Marie-laure Aknin, Bronwen R. Burton, Emma C. Kerr, Lindsay B. Nicholson, Neil A. Williams, Andrew D DickAbstract:PURPOSE. To investigate the efficacy of the B subunit of Escherichia coli heat-labile enterotoxin (EtxB) in the treatment of ocular autoimmune disease. Murine experimental autoimmune uveoretinitis (EAU) is an animal model of autoimmune Posterior Uveitis initiated by retinal antigen-specific Th1 and Th17 CD4 T cells, which activate myeloid cells, inducing retinal damage. EtxB is a potent immune modulator that ameliorates other Th1-mediated autoimmune diseases, enhancing regulatory T-cell activity.