NCT01449682

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Retina Macula Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Retinal Vein Occlusion
• Macular Edema

Interventions

Type	Name	Description
DRUG	Ozurdex	0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies
DRUG	Ozurdex	0.7 mg intravitreal DEX implant on first visit then every 16 weeks

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-07-01
• Completion: 2013-02-01
• First posted: 2011-10-10
• Last updated: 2017-05-31
• Results posted: 2017-05-31

Locations

1 site across 1 country: United States