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OpenTrials
Completed

NCT Number: NCT01449682

Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With 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.

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Retina Macula Institute

Torrance, California, 90503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ozurdex

Drug

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

Primary outcomes

  1. Macular Function Using Microperimetry

    Time frame: baseline to 48 weeks

    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

  2. Macular Function Using Multi-focal ERG

    Time frame: baseline to 48 weeks

    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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Retina Macula Institute

Other

Collaborators

  • Allergan

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 10, 2011
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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