Raj K Maturi1, Ayala Pollack, Harvey S Uy, Monica Varano, Andre M V Gomes, Xiao-Yan Li, Harry Cui, Jean Lou, Yehia Hashad, Scott M Whitcup. 1. *Midwest Eye Institute, Indianapolis, Indiana; †Kaplan Medical Center, Rehovot, Israel; ‡Peregrine Eye and Laser Institute, Makati, Philippines; §Fondazione GB Bietti-IRCCS, Rome, Italy; ¶Ocular Surgery Center, University of São Paulo, São Paulo, Brazil; **Allergan plc, Irvine, California; ††Avanir Pharmaceuticals, Inc, Aliso Viejo, California; and ‡‡Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, California.
Abstract
PURPOSE: To evaluate the occurrence, management, and clinical significance of increases in intraocular pressure (IOP) in patients with diabetic macular edema treated withdexamethasone intravitreal implant (DEX implant). METHODS: Randomized, multicenter, 3-year, Phase III study. Patients (N = 1,048) with diabetic macular edema were randomized to DEX implant 0.7-mg, DEX implant 0.35-mg, or sham procedure with retreatment allowed at ≥6-month intervals (seven injections maximum). RESULTS: In the DEX implant 0.7-mg, DEX implant 0.35-mg, and sham groups, respectively, ≥10-mmHg IOP increases from baseline occurred in 27.7%, 24.8%, and 3.7% of patients, and their frequency did not increase with repeat injections. IOP-lowering medication was used by 41.5%, 37.6%, and 9.1% of patients. Only one patient (0.3%) in each DEX implant group had filtering surgery to manage a steroid-induced IOP increase. Among DEX implant 0.7-mg-treated patients with and without a ≥10-mmHg IOP increase, 21.9% (21 of 96) and 22.4% (57 of 255), respectively, achieved ≥15-letter best-corrected visual acuity gain at the end of the study, and mean average change in central retinal thickness from baseline was -127 μm and -106 μm, respectively. CONCLUSION:DEX implant demonstrated clear benefit of treatment despite increases in IOP. Sequential implants had no cumulative effect on IOP.
RCT Entities:
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) with diabetic macular edema were randomized to DEX implant 0.7-mg, DEX implant 0.35-mg, or sham procedure with retreatment allowed at ≥6-month intervals (seven injections maximum). RESULTS: In the DEX implant 0.7-mg, DEX implant 0.35-mg, and sham groups, respectively, ≥10-mmHg IOP increases from baseline occurred in 27.7%, 24.8%, and 3.7% of patients, and their frequency did not increase with repeat injections. IOP-lowering medication was used by 41.5%, 37.6%, and 9.1% of patients. Only one patient (0.3%) in each DEX implant group had filtering surgery to manage a steroid-induced IOP increase. Among DEX implant 0.7-mg-treated patients with and without a ≥10-mmHg IOP increase, 21.9% (21 of 96) and 22.4% (57 of 255), respectively, achieved ≥15-letter best-corrected visual acuity gain at the end of the study, and mean average change in central retinal thickness from baseline was -127 μm and -106 μm, respectively. CONCLUSION:DEX implant demonstrated clear benefit of treatment despite increases in IOP. Sequential implants had no cumulative effect on IOP.
Authors: Raj K Maturi; Adam R Glassman; Danni Liu; Roy W Beck; Abdhish R Bhavsar; Neil M Bressler; Lee M Jampol; Michele Melia; Omar S Punjabi; Hani Salehi-Had; Jennifer K Sun Journal: JAMA Ophthalmol Date: 2018-01-01 Impact factor: 7.389
Authors: M Elizabeth Fini; Stephen G Schwartz; Xiaoyi Gao; Shinwu Jeong; Nitin Patel; Tatsuo Itakura; Marianne O Price; Francis W Price; Rohit Varma; W Daniel Stamer Journal: Prog Retin Eye Res Date: 2016-09-22 Impact factor: 21.198