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Scott M. Whitcup - One of the best experts on this subject based on the ideXlab platform.
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intraocular pressure in patients with diabetic macular edema treated with dexamethasone Intravitreal Implant in the 3 year mead study
Retina-the Journal of Retinal and Vitreous Diseases, 2016Co-Authors: Raj K Maturi, Harry Cui, Jean Lou, Monica Varano, Ayala Pollack, Andre Marcelo Vieira Gomes, Yehia Hashad, Scott M. WhitcupAbstract:Purpose:To evaluate the occurrence, management, and clinical significance of increases in intraocular pressure (IOP) in patients with diabetic macular edema treated with dexamethasone Intravitreal Implant (DEX Implant).Methods:Randomized, multicenter, 3-year, Phase III study. Patients (N = 1,048) wi
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dexamethasone Intravitreal Implant in previously treated patients with diabetic macular edema subgroup analysis of the mead study
BMC Ophthalmology, 2015Co-Authors: Albert J Augustin, Anat Loewenstein, Baruch D Kuppermann, Harry Cui, Paolo Lanzetta, Yehia Hashad, Scott M. WhitcupAbstract:Dexamethasone Intravitreal Implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME. Three-year, randomized, sham-controlled phase 3 study in patients with DME, best-corrected visual acuity (BCVA) of 34–68 Early Treatment Diabetic Retinopathy Study letters (20/200–20/50 Snellen equivalent), and central retinal thickness (CRT) ≥300 μm measured by time-domain optical coherence tomography. Patients were randomized to 1 of 2 doses of DEX (0.7 mg or 0.35 mg), or to sham procedure, with retreatment no more than every 6 months. The primary endpoint was ≥15-letter gain in BCVA at study end. Average change in BCVA and CRT from baseline during the study (area-under-the-curve approach) and adverse events were also evaluated. The present subgroup analysis evaluated outcomes in patients randomized to DEX 0.7 (marketed dose) or sham based on prior treatment for DME at study entry. Baseline characteristics of previously treated DEX 0.7 (n = 247) and sham (n = 261) patients were similar. In the previously treated subgroup, mean number of treatments over 3 years was 4.1 for DEX 0.7 and 3.2 for sham, 21.5 % of DEX 0.7 patients versus 11.1 % of sham had ≥15-letter BCVA gain from baseline at study end (P = 0.002), mean average BCVA change from baseline was +3.2 letters with DEX 0.7 versus +1.5 letters with sham (P = 0.024), and mean average CRT change from baseline was −126.1 μm with DEX 0.7 versus −39.0 μm with sham (P < 0.001). Cataract-related adverse events were reported in 70.3 % of baseline phakic patients in the previously treated DEX 0.7 subgroup; vision gains were restored following cataract surgery. DEX 0.7 significantly improved visual and anatomic outcomes in patients with DME previously treated with laser, Intravitreal anti-vascular endothelial growth factor, Intravitreal triamcinolone acetonide, or a combination of these therapies. The safety profile of DEX 0.7 in previously treated patients was similar to its safety profile in the total study population. ClinicalTrials.gov NCT00168337 and NCT00168389 , registered 12 September 2005
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three year randomized sham controlled trial of dexamethasone Intravitreal Implant in patients with diabetic macular edema
Ophthalmology, 2014Co-Authors: David S Boyer, Francesco Bandello, Rubens Belfort, Harry Cui, Albert J Augustin, Raj K Maturi, Yehia Hashad, Younghee Yoon, Scott M. WhitcupAbstract:Purpose To evaluate the safety and efficacy of dexamethasone Intravitreal Implant (Ozurdex, DEX Implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME). Design Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis. Participants Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of ≥300 μm by optical coherence tomography. Methods Patients were randomized in a 1:1:1 ratio to study treatment with DEX Implant 0.7 mg, DEX Implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at ≤40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months. Main Outcome Measures The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of ≥15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP). Results Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX Implant 0.7 mg, DEX Implant 0.35 mg, and sham, respectively. The percentage of patients with ≥15-letter improvement in BCVA from baseline at study end was greater with DEX Implant 0.7 mg (22.2%) and DEX Implant 0.35 mg (18.4%) than sham (12.0%; P ≤ 0.018). Mean average reduction in CRT from baseline was greater with DEX Implant 0.7 mg (−111.6 μm) and DEX Implant 0.35 mg (−107.9 μm) than sham (−41.9 μm; P Conclusions The DEX Implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. The safety profile was acceptable and consistent with previous reports.
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onset and duration of visual acuity improvement after dexamethasone Intravitreal Implant in eyes with macular edema due to retinal vein occlusion
Retina-the Journal of Retinal and Vitreous Diseases, 2014Co-Authors: Baruch D Kuppermann, Francesco Bandello, Anat Loewenstein, Julia A Haller, Jenny Jiao, Scott M. WhitcupAbstract:PURPOSE To evaluate the onset and duration of improvement in best-corrected visual acuity (BCVA) in eyes treated with dexamethasone Intravitreal Implant 0.7 mg (DEX Implant) for macular edema after branch or central retinal vein occlusion. METHODS Post hoc analysis of data from 2 previously reported multicenter, 6-month, randomized sham-controlled clinical trials. Patients received a single DEX Implant (n = 427) or sham procedure (n = 426) in the study eye. The primary endpoint was the percentage of eyes with ≥ 15-letter improvement in BCVA from baseline at postImplant Day 7. RESULTS The baseline mean BCVA was 20/80. At Day 7, 10.3% of DEX Implant-treated eyes versus 4.0% of sham-treated eyes (P < 0.001) had ≥ 15-letter improvement in the BCVA, and 27.2% of DEX Implant-treated eyes versus 10.6% of sham-treated eyes had ≥ 10-letter improvement (P < 0.001). The mean improvement at Day 7 was 5.3 letters (branch retinal vein occlusion, 5.1; and central retinal vein occlusion, 5.8) with DEX Implant and 1.6 letters (branch retinal vein occlusion, 2.3; and central retinal vein occlusion, 0.1) with sham (P < 0.001). The mean time from initial observation of ≥ 15-letter BCVA gain to the last observation of ≥ 15-letter BCVA gain was 70 days. CONCLUSION Dexamethasone Intravitreal Implant treatment led to improvement in BCVA compared with sham procedure as early as postImplant Day 7. The duration of ≥ 3-line improvement was typically 2 to 3 months.
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dexamethasone Intravitreal Implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema
Ophthalmology, 2013Co-Authors: David Callanan, Baruch D Kuppermann, David A Hollander, Rhett M Schiffman, David S Boyer, Sunil Gupta, Charlie C Liu, Thomas A Ciulla, Michael Singer, Scott M. WhitcupAbstract:Purpose To evaluate Ozurdex (dexamethasone Intravitreal Implant [DEX Implant]; Allergan, Inc, Irvine, CA) 0.7 mg combined with laser photocoagulation compared with laser alone for treatment of diffuse diabetic macular edema (DME). Design Randomized, controlled, multicenter, double-masked, parallel-group, 12-month trial. Participants Two hundred fifty-three patients with retinal thickening and impaired vision resulting from diffuse DME in at least 1 eye (the study eye) were enrolled. Intervention Patients were randomized to treatment in the study eye with DEX Implant at baseline plus laser at month 1 (combination treatment; n = 126) or sham Implant at baseline and laser at month 1 (laser alone; n = 127) and could receive up to 3 additional laser treatments and 1 additional DEX Implant or sham treatment as needed. Main Outcome Measures The primary efficacy variable was the percentage of patients who had a 10-letter or more improvement in best-corrected visual acuity (BCVA) from baseline at month 12. Other key efficacy variables included the change in BCVA from baseline and the area of vessel leakage evaluated with fluorescein angiography. Safety variables included adverse events and intraocular pressure (IOP). Results The percentage of patients who gained 10 letters or more in BCVA at month 12 did not differ between treatment groups, but the percentage of patients was significantly greater in the combination group at month 1 ( P P = 0.007). In patients with angiographically verified diffuse DME, the mean improvement in BCVA was significantly greater with DEX Implant plus laser treatment than with laser treatment alone (up to 7.9 vs. 2.3 letters) at all time points through month 9 ( P ≤0.013). Decreases in the area of diffuse vascular leakage measured angiographically were significantly larger with DEX Implant plus laser treatment through month 12 ( P ≤0.041). Increased IOP was more common with combination treatment. No surgeries for elevated IOP were required. Conclusions There was no significant between-group difference at month 12. However, significantly greater improvement in BCVA, as demonstrated by changes from baseline at various time points up to 9 months and across time based on the area under the curve analysis, occurred in patients with diffuse DME treated with DEX Implant plus laser than in patients treated with laser alone. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.
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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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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fluocinolone acetonide Intravitreal Implant for diabetic macular edema a 3 year multicenter randomized controlled clinical trial
Ophthalmology, 2011Co-Authors: Andrew P Pearson, David Callanan, Timothy L Comstock, Lawrence S Morse, Paul Ashton, Brian Levy, Eric S Mann, Dean EliottAbstract:Purpose We studied the 3-year efficacy and safety results of a 4-year study evaluating fluocinolone acetonide (FA) Intravitreal Implants in eyes with persistent or recurrent diabetic macular edema (DME). Design Prospective, evaluator-masked, controlled, multicenter clinical trial. Participants We included 196 eyes with refractory DME. Methods Patients were randomized 2:1 to receive 0.59-mg FA Implant (n = 127) or standard of care (SOC additional laser or observation; n=69). The Implant was inserted through a pars plana incision. Visits were scheduled on day 2, weeks 1, 3, 6, 12, and 26, and thereafter every 13 weeks through 3 years postImplantation. Main Outcome Measures The primary efficacy outcome was ≥15-letter improvement in visual acuity (VA) at 6 months. Secondary outcomes included resolution of macular retinal thickening and Diabetic Retinopathy Severity Score (DRSS). Safety measures included incidence of adverse events (AEs). Results Overall, VA improved ≥3 lines in 16.8% of Implanted eyes at 6 months ( P =0.0012; SOC, 1.4%); in 16.4% at 1 year ( P =0.1191; SOC, 8.1%); in 31.8% at 2 years ( P =0.0016; SOC, 9.3%); and in 31.1% at 3 years ( P =0.1566; SOC, 20.0%). The number of Implanted eyes with no evidence of retinal thickening at the center of the macula was higher than SOC eyes at 6 months ( P P P =0.016), and 3 years ( P =0.861). A higher rate of improvement and lower rate of decline in DRSS occurred in the Implanted group versus the SOC group at 6 months ( P =0.0006), 1 year ( P =0.0016), 2 years ( P =0.012), and 3 years ( P =0.0207). Intraocular pressure (IOP) ≥30 mmHg was recorded in 61.4% of Implanted eyes (SOC, 5.8%) at any time and 33.8% required surgery for ocular hypertension by 4 years. Of Implanted phakic eyes, 91% (SOC, 20%) had cataract extraction by 4 years. Conclusions The FA Intravitreal Implant met the primary and secondary outcomes, with significantly improved VA and DRSS and reduced DME. The most common AEs included cataract progression and elevated IOP. The 0.59-mg FA Intravitreal Implant may be an effective treatment for eyes with persistent or recurrent DME. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references.
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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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intraocular pressure in patients with uveitis treated with fluocinolone acetonide Implants
Archives of Ophthalmology, 2007Co-Authors: David G Godfrey, David Callanan, Andrew P Pearson, Dale W Usner, Anthony Jh Hall, Timothy L ComstockAbstract:OBJECTIVE To report the incidence and management of elevated intraocular pressure (IOP) in patients with uveitis treated with the fluocinolone acetonide (FA) Intravitreal Implant. DESIGN Pooled data from 3 multicenter, double-masked, randomized, controlled, phase 2b/3 clinical trials evaluating the safety and efficacy of the 0.59-mg or 2.1-mg FA Intravitreal Implant or standard therapy were analyzed. RESULTS During the 3-year follow-up, 71.0% of Implanted eyes had an IOP increase of 10 mm Hg or more than baseline and 55.1%, 24.7%, and 6.2% of eyes reached an IOP of 30 mm Hg or more, 40 mm Hg or more, and 50 mm Hg or more, respectively. Topical IOP-lowering medication was administered in 74.8% of Implanted eyes, and IOP-lowering surgeries, most of which were trabeculectomies (76.2%), were performed on 36.6% of Implanted eyes. Intraocular pressure-lowering surgeries were considered a success (postoperative IOP of 6-21 mm Hg with or without additional IOP-lowering medication) in 85.1% of eyes at 1 year. The rate of hypotony (IOP Implanted eyes not subjected to surgery (35.4%) (P = .09). CONCLUSION Elevated IOP is a significant complication with the FA Intravitreal Implant but may be controlled with medication and surgery.
Ramin Khoramnia - One of the best experts on this subject based on the ideXlab platform.
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preventing relapse in non infectious uveitis affecting the posterior segment of the eye evaluating the 0 2 μg day fluocinolone acetonide Intravitreal Implant iluvien
Journal of Ophthalmic Inflammation and Infection, 2020Co-Authors: B Bodaghi, Glenn J Jaffe, Ramin Khoramnia, Carlos PavesioAbstract:The current article is a short review of an Alimera Sciences-sponsored symposium held during The 15th International Ocular Inflammation Society Congress in Taiwan on the 14th November 2019 entitled, ‘Preventing relapse of non-infectious uveitis effecting the posterior segment of the eye – evaluating the 0.2 μg/day fluocinolone acetonide Intravitreal Implant.’ The fluocinolone acetonide Intravitreal Implant was approved in Europe for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye and offers a systemic therapy-sparing treatment option by providing low daily dose of corticosteroid into the vitreous for up to 3 years. In the symposium, the presenters reported clinical outcomes from patients with non-infectious uveitis effecting the posterior segment of the eye to support the effectiveness and safety of the Implant for up to 3 years in both randomised controlled trials and real-world practices. Data showed that over a 36 month period, treatment with the fluocinolone acetonide Intravitreal Implant was associated with significantly fewer episodes of uveitic recurrence, a significantly longer time to uveitic recurrence, greater improvement in visual acuity, a lower need for adjunctive therapy, and an acceptable safety profile.
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Injectable 0.19-mg fluocinolone acetonide Intravitreal Implant for the treatment of non-infectious uveitic macular edema
Journal of Ophthalmic Inflammation and Infection, 2019Co-Authors: Lea F. Weber, Stefanie Marx, Gerd U. Auffarth, Alexander F. Scheuerle, Tamer Tandogan, Christian Mayer, Ramin KhoramniaAbstract:Background A retrospective observational clinical study to evaluate the safety and effectiveness of the injectable 0.19-mg fluocinolone acetonide Intravitreal Implant (ILUVIEN) in the treatment of non-infectious uveitic macular edema. Results Data are presented from eight patients (11 eyes) with non-infectious uveitic macular edema who were treated with a 0.19-mg fluocinolone acetonide Implant. Nine out of 11 eyes were pseudophakic prior to Implantation of fluocinolone acetonide Implant, and both phakic eyes required cataract surgery during the follow-up period (the median follow-up was 19 months; range, 8–42 months). Effectiveness and safety were assessed from changes in central retinal thickness (measured using spectral domain optical coherence tomography), corrected distance visual acuity, uveitic activity, and intraocular pressure. The main outcome measures were changes in central retinal thickness, corrected distance visual acuity, uveitic activity, and intraocular pressure. In 11/11 eyes, central retinal thickness improved between months 1 and 3. The mean maximum decrease of central retinal thickness throughout the follow-up period was 168 ± 202 μm (± standard deviation). Nine out of 11 eyes showed an improvement in corrected distance visual acuity (between + 1 and + 8 lines), and 2/11 eyes lost corrected distance visual acuity (− 1 and − 3 lines, respectively). Nine out of 11 eyes presented with inactive inflammation during the follow-up period, and in 1/11 eyes, there was a relapse at month 42. Four out of 11 eyes presented with a relapse of macular edema between months 3 and 8. The mean increase in intraocular pressure was 2.1 ± 4.7 mmHg. Nine eyes were pseudophakic prior to Implantation of the injectable fluocinolone acetonide Intravitreal Implant. Both phakic patients developed a cataract that was treated with cataract surgery in the follow-up period. Conclusions In this small case series with long-term follow-up, treatment of non-infectious uveitic macular edema with the injectable fluocinolone acetonide Implant was associated with improved central retinal thickness and corrected distance visual acuity and a manageable safety profile. The advantage of this device is the long-term drug release and the fact that it can be injected into the vitreous as a minor surgical procedure, which is in contrast to other treatment options.
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Injectable 0.19-mg fluocinolone acetonide Intravitreal Implant for the treatment of non-infectious uveitic macular edema.
Journal of ophthalmic inflammation and infection, 2019Co-Authors: Lea F. Weber, Stefanie Marx, Gerd U. Auffarth, Alexander F. Scheuerle, Tamer Tandogan, Christian Mayer, Ramin KhoramniaAbstract:A retrospective observational clinical study to evaluate the safety and effectiveness of the injectable 0.19-mg fluocinolone acetonide Intravitreal Implant (ILUVIEN) in the treatment of non-infectious uveitic macular edema. Data are presented from eight patients (11 eyes) with non-infectious uveitic macular edema who were treated with a 0.19-mg fluocinolone acetonide Implant. Nine out of 11 eyes were pseudophakic prior to Implantation of fluocinolone acetonide Implant, and both phakic eyes required cataract surgery during the follow-up period (the median follow-up was 19 months; range, 8–42 months). Effectiveness and safety were assessed from changes in central retinal thickness (measured using spectral domain optical coherence tomography), corrected distance visual acuity, uveitic activity, and intraocular pressure. The main outcome measures were changes in central retinal thickness, corrected distance visual acuity, uveitic activity, and intraocular pressure. In 11/11 eyes, central retinal thickness improved between months 1 and 3. The mean maximum decrease of central retinal thickness throughout the follow-up period was 168 ± 202 μm (± standard deviation). Nine out of 11 eyes showed an improvement in corrected distance visual acuity (between + 1 and + 8 lines), and 2/11 eyes lost corrected distance visual acuity (− 1 and − 3 lines, respectively). Nine out of 11 eyes presented with inactive inflammation during the follow-up period, and in 1/11 eyes, there was a relapse at month 42. Four out of 11 eyes presented with a relapse of macular edema between months 3 and 8. The mean increase in intraocular pressure was 2.1 ± 4.7 mmHg. Nine eyes were pseudophakic prior to Implantation of the injectable fluocinolone acetonide Intravitreal Implant. Both phakic patients developed a cataract that was treated with cataract surgery in the follow-up period. In this small case series with long-term follow-up, treatment of non-infectious uveitic macular edema with the injectable fluocinolone acetonide Implant was associated with improved central retinal thickness and corrected distance visual acuity and a manageable safety profile. The advantage of this device is the long-term drug release and the fact that it can be injected into the vitreous as a minor surgical procedure, which is in contrast to other treatment options.
Dale W Usner - One of the best experts on this subject based on the ideXlab platform.
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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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intraocular pressure in patients with uveitis treated with fluocinolone acetonide Implants
Archives of Ophthalmology, 2007Co-Authors: David G Godfrey, David Callanan, Andrew P Pearson, Dale W Usner, Anthony Jh Hall, Timothy L ComstockAbstract:OBJECTIVE To report the incidence and management of elevated intraocular pressure (IOP) in patients with uveitis treated with the fluocinolone acetonide (FA) Intravitreal Implant. DESIGN Pooled data from 3 multicenter, double-masked, randomized, controlled, phase 2b/3 clinical trials evaluating the safety and efficacy of the 0.59-mg or 2.1-mg FA Intravitreal Implant or standard therapy were analyzed. RESULTS During the 3-year follow-up, 71.0% of Implanted eyes had an IOP increase of 10 mm Hg or more than baseline and 55.1%, 24.7%, and 6.2% of eyes reached an IOP of 30 mm Hg or more, 40 mm Hg or more, and 50 mm Hg or more, respectively. Topical IOP-lowering medication was administered in 74.8% of Implanted eyes, and IOP-lowering surgeries, most of which were trabeculectomies (76.2%), were performed on 36.6% of Implanted eyes. Intraocular pressure-lowering surgeries were considered a success (postoperative IOP of 6-21 mm Hg with or without additional IOP-lowering medication) in 85.1% of eyes at 1 year. The rate of hypotony (IOP Implanted eyes not subjected to surgery (35.4%) (P = .09). CONCLUSION Elevated IOP is a significant complication with the FA Intravitreal Implant but may be controlled with medication and surgery.
Carlos Pavesio - One of the best experts on this subject based on the ideXlab platform.
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preventing relapse in non infectious uveitis affecting the posterior segment of the eye evaluating the 0 2 μg day fluocinolone acetonide Intravitreal Implant iluvien
Journal of Ophthalmic Inflammation and Infection, 2020Co-Authors: B Bodaghi, Glenn J Jaffe, Ramin Khoramnia, Carlos PavesioAbstract:The current article is a short review of an Alimera Sciences-sponsored symposium held during The 15th International Ocular Inflammation Society Congress in Taiwan on the 14th November 2019 entitled, ‘Preventing relapse of non-infectious uveitis effecting the posterior segment of the eye – evaluating the 0.2 μg/day fluocinolone acetonide Intravitreal Implant.’ The fluocinolone acetonide Intravitreal Implant was approved in Europe for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye and offers a systemic therapy-sparing treatment option by providing low daily dose of corticosteroid into the vitreous for up to 3 years. In the symposium, the presenters reported clinical outcomes from patients with non-infectious uveitis effecting the posterior segment of the eye to support the effectiveness and safety of the Implant for up to 3 years in both randomised controlled trials and real-world practices. Data showed that over a 36 month period, treatment with the fluocinolone acetonide Intravitreal Implant was associated with significantly fewer episodes of uveitic recurrence, a significantly longer time to uveitic recurrence, greater improvement in visual acuity, a lower need for adjunctive therapy, and an acceptable safety profile.
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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.
