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

Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01449682
• Other study ID #: IIT-287
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 6, 2011
• Last updated: January 13, 2013
• Start date: October 2011
• Est. completion date: September 2013

Study information

• Verified date: January 2013
• Source: Retina Macula Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Ozurdex
0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies
• Ozurdex
0.7 mg intravitreal DEX implant on first visit then every 16 weeks

Locations

Country	Name	City	State
United States	Retina Macula Institute	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Retina Macula Institute	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No