Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of an Intravitreal Dexamethasone Implant on Macular Function in Retinal Vein Occlusion Following Treatment With Intravitreal Anti-VEGF Injections.

Conditions
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Retinal Vein Occlusion, Macular Edema

Intervention / Treatment
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* Drug: Ozurdex
* Drug: Ozurdex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 45 days. Age 18 years or older ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800 Central foveal thickness >275 microns or presence of cystic edema on OCT studies. For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study. Ability to provide written informed consent • Capable of complying with study protocol Exclusion Criteria: History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication. Intraocular injection of steroid medication within prior 4 months Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician. Previous laser photocoagulation within 4 months of study Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician Patients who are pregnant. Unwilling or unable to follow or comply with all study related procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ozurdex PRN<br>0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT | Drug: Ozurdex<br>* 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies<br>* Other names: Dexamethasone implant, DEX implant;|
| Active Comparator: Ozurdex Q16 weeks<br>0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks | Drug: Ozurdex<br>* 0.7 mg intravitreal DEX implant on first visit then every 16 weeks<br>* Other names: dexamethasone implant, DEX implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Function Using Microperimetry | To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups | baseline to 48 weeks | 
| Macular Function Using Multi-focal ERG | To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups | baseline to 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups |  | baseline to 48 weeks | 
| To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups |  | baseline to 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BRVO, CRVO, Macular Edema, Anti-VEGF, Ozurdex