A Randomized Paired-Eye Trial of Intravitreal Dexamethasone Implant for Cystoid Macular Edema in Retinitis Pigmentosa

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.

Management of Cystoid Macular Edema in Retinitis Pigmentosa: A Systematic Review and Meta-Analysis

“…The average change of CMT varied from −58.56– −320.62 μm after different local steroids treatments, as shown in Figures 6A,B . Moreover, in 2 comparative studies, intravitreal dexamethasone implant (0.7 mg, Ozurdex) showed better results in reducing CMT than the CAIs ( 14 , 16 ). Figure 7 is a representative of RP-CME treated with dexamethasone implant, illustrating the macular change by OCT during the treatment and follow-up [figure reproduced from Veritti et al ( 14 )].…”

“…Two systematic reviews and one meta-analysis have been published regarding the treatment of RP-CME, with results of studies up to 2016 summarized and analyzed ( 4 , 8 , 12 ). Nevertheless, during the past 5 years, more evidence has been published on the application of CAIs ( 13 – 18 ), steroids ( 10 , 11 , 13 , 14 , 16 , 19 ), anti-VEGF therapy ( 20 ), and LASER treatment ( 21 ). Therefore, we conducted this updated systematic review and meta-analysis, to summarize the existing evidence on the treatment of RP-CME.…”

Intravitreal Dexamethasone Implant as a Sustained Release Drug Delivery Device for the Treatment of Ocular Diseases: A Comprehensive Review of the Literature

“…Table 2 summarizes characteristics and main outcomes of case reports or small series evaluating the efficacy and safety of DEX implant in RP [111][112][113][114][115]. Additionally, a couple of studies tried to elucidate the role of Dex implant in the treatment of CME secondary to RP [115,116]. Mansour et al, analyzed the outcomes of 45 eyes (34 patients) affected by CME secondary to RP treated with Ozurdex with a mean follow-up of 15.5 months [115].…”

“…Park et al, conducted a randomized, noncontrolled, paired-eye, single crossover clinical trial in which one eye of RP patients with bilateral CME was treated by Dex implant while the fellow eye was observed [116]. The authors treated 14 patients for 12 months and reported that Ozurdex could reduce the CME secondary to RP, but repeated injections were required in order to maintain the anatomical and functional results.…”

“…Additionally, a couple of studies tried to elucidate the role of Dex implant in the treatment of CME secondary to RP [ 115 , 116 ]. Mansour et al, analyzed the outcomes of 45 eyes (34 patients) affected by CME secondary to RP treated with Ozurdex with a mean follow-up of 15.5 months [ 115 ].…”