Un Chul Park1,2, Jung Hyun Park1,3, Dae Joong Ma1,2, In Hwan Cho1,2, Baek-Lok Oh1,2, Hyeong Gon Yu1,2. 1. Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea. 2. Retinal Degeneration Research Laboratory, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea; and. 3. Department of Ophthalmology, Inje University Seoul Paik Hospital, Seoul, Korea.
Abstract
PURPOSE: To evaluate the efficacy and safety of intravitreal dexamethasone (DEX) implant in retinitis pigmentosa patients with cystoid macular edema (CME). METHODS: In this randomized, noncontrolled, paired-eye, single crossover clinical trial, one eye of retinitis pigmentosa patients with bilateral CME with central macular thickness of >250 µm was randomized to intravitreal DEX implant while the fellow eye was observed. Both eyes were started on topical dorzolamide. At Month 6, DEX implant was eligible for both eyes when CME was >250 µm. Patients were followed up until Month 12. Primary outcome measures were the central macular thickness and best-corrected visual acuity changes from baseline at Month 2. RESULTS:Fourteen patients with bilateral RP-CME were included. Study eyes showed significant central macular thickness decrease (median, -147.5 µm; P = 0.001) and best-corrected visual acuity improvement (median, +6 letters; P = 0.001) at Month 2, but not at Month 6. Intravitreal DEX implant at Month 6 produced comparable efficacy to baseline treatment in 11 fellow eyes and 12 study eyes. Topical dorzolamide did not show significant therapeutic efficacy. During 12 months, elevated intraocular pressure of >21 mmHg and cataract progression were observed in 14.3% and 40.0% of study eyes. CONCLUSION:Intravitreal DEX implant can both reduce macular thickness and improve vision in RP-CME, while repeated injection is required.
RCT Entities:
PURPOSE: To evaluate the efficacy and safety of intravitreal dexamethasone (DEX) implant in retinitis pigmentosapatients with cystoid macular edema (CME). METHODS: In this randomized, noncontrolled, paired-eye, single crossover clinical trial, one eye of retinitis pigmentosapatients with bilateral CME with central macular thickness of >250 µm was randomized to intravitreal DEX implant while the fellow eye was observed. Both eyes were started on topical dorzolamide. At Month 6, DEX implant was eligible for both eyes when CME was >250 µm. Patients were followed up until Month 12. Primary outcome measures were the central macular thickness and best-corrected visual acuity changes from baseline at Month 2. RESULTS: Fourteen patients with bilateral RP-CME were included. Study eyes showed significant central macular thickness decrease (median, -147.5 µm; P = 0.001) and best-corrected visual acuity improvement (median, +6 letters; P = 0.001) at Month 2, but not at Month 6. Intravitreal DEX implant at Month 6 produced comparable efficacy to baseline treatment in 11 fellow eyes and 12 study eyes. Topical dorzolamide did not show significant therapeutic efficacy. During 12 months, elevated intraocular pressure of >21 mmHg and cataract progression were observed in 14.3% and 40.0% of study eyes. CONCLUSION: Intravitreal DEX implant can both reduce macular thickness and improve vision in RP-CME, while repeated injection is required.