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

Primary Purpose

Retinal Vein Occlusion, Macular Edema

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ozurdex
Ozurdex
Sponsored by
Retina Macula Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion focused on measuring BRVO, CRVO, Macular Edema, Anti-VEGF, Ozurdex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Retina Macula Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ozurdex PRN

Ozurdex Q16 weeks

Arm Description

0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT

0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
October 6, 2011
Last Updated
April 26, 2017
Sponsor
Retina Macula Institute
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01449682
Brief Title
Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.
Official Title
Efficacy of an Intravitreal Dexamethasone Implant on Macular Function in Retinal Vein Occlusion Following Treatment With Intravitreal Anti-VEGF Injections.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Retina Macula Institute
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion, Macular Edema
Keywords
BRVO, CRVO, Macular Edema, Anti-VEGF, Ozurdex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozurdex PRN
Arm Type
Active Comparator
Arm Description
0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT
Arm Title
Ozurdex Q16 weeks
Arm Type
Active Comparator
Arm Description
0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks
Intervention Type
Drug
Intervention Name(s)
Ozurdex
Other Intervention Name(s)
Dexamethasone implant, DEX implant
Intervention Description
0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies
Intervention Type
Drug
Intervention Name(s)
Ozurdex
Other Intervention Name(s)
dexamethasone implant, DEX implant
Intervention Description
0.7 mg intravitreal DEX implant on first visit then every 16 weeks
Primary Outcome Measure Information:
Title
Macular Function Using Microperimetry
Description
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
Time Frame
baseline to 48 weeks
Title
Macular Function Using Multi-focal ERG
Description
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
Time Frame
baseline to 48 weeks
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron P Gallemore, M.D. Ph.D
Organizational Affiliation
Retina Macula Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Behnam Sharareh, B.S
Organizational Affiliation
Retina Macula Institute
Official's Role
Study Director
Facility Information:
Facility Name
Retina Macula Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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