Overview

This trial is active, not recruiting.

Conditions retinal vein occlusion, macular edema
Treatments ozurdex
Phase phase 3
Sponsor Retina Macula Institute
Collaborator Allergan
Start date October 2011
End date July 2013
Trial size 10 participants
Trial identifier NCT01449682, IIT-287

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT
ozurdex Dexamethasone implant, DEX implant
0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies
(Active Comparator)
0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks
ozurdex dexamethasone implant, DEX implant
0.7 mg intravitreal DEX implant on first visit then every 16 weeks

Primary Outcomes

Measure
Macular function using Microperimetry
time frame: baseline to 48 weeks
Macular function using multi-focal ERG
time frame: baseline to 48 weeks

Secondary Outcomes

Measure
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
time frame: 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
time frame: baseline to 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Efficacy of an Intravitreal Dexamethasone Implant on Macular Function in Retinal Vein Occlusion Following Treatment With Intravitreal Anti-VEGF Injections.
Principal investigator Ron P Gallemore, M.D. Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Retina Macula Institute.