Conditions: Retinal Vein Occlusion Macular Edema
Keywords: BRVO CRVO Macular Edema Anti-VEGF Ozurdex
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: yes

Brief summary:
To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections.

Detailed description:
The efficacy of the DEX implant on macular edema for RVO is well established in multiple clinical trials. However, the duration and frequency of re-treatment have not been extensively explored. In addition, no prior studies have tested the efficacy of the DEX implant on retinal and macular function using diagnostic testing measurements such as multi-focal ERG, microperimetry and RAM testing. Since VA and OCT outcomes do not always correlate, these other assessments (mf-ERG, microperimetry, RAM testing) may be useful as early predictors of when or if patients should be retreated. This study will assess 2 groups (0.7mg PRN and 0.7mg Q16 weeks) and assess high resolution OCT, RAM testing, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreated based on any fluid on OCT, we will investigate if microperimetry or multifocal ERG changes would have been an earlier predictor of fluid returning.

Arms:
arm 1: 0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT arm 2: 0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks

Interventions: intervention 1: Ozurdex intervention 2: Ozurdex
Intervention descriptions: intervention 1: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies intervention 2: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks

Protocol document: