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.

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.

Study Overview

• Status: Completed
• Conditions: Macular Edema; Retinal Vein Occlusion
• Intervention / Treatment: Drug: Ozurdex; Drug: Ozurdex

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Torrance, California, United States, 90503
      • Retina Macula Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ozurdex PRN; 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; 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies; Other Names: Dexamethasone implant, DEX implant; Drug: Ozurdex; 0.7 mg intravitreal DEX implant on first visit then every 16 weeks; Other Names: dexamethasone implant, DEX implant
Active Comparator: Ozurdex Q16 weeks; 0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks	Drug: Ozurdex; 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies; Other Names: Dexamethasone implant, DEX implant; Drug: Ozurdex; 0.7 mg intravitreal DEX implant on first visit then every 16 weeks; Other Names: dexamethasone implant, DEX implant

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Retina Macula Institute
• Collaborators: Allergan
• Investigators: Principal Investigator: Ron P Gallemore, M.D. Ph.D, Retina Macula Institute; Study Director: Behnam Sharareh, B.S, Retina Macula Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: October 6, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 10, 2011

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: CRVO; BRVO; Macular Edema; Anti-VEGF; Ozurdex
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: IIT-287