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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Retina Macula Institute
ClinicalTrials.gov Identifier:
NCT01449682
First received: October 6, 2011
Last updated: January 13, 2013
Last verified: January 2013

October 6, 2011
January 13, 2013
October 2011
July 2013   (final data collection date for primary outcome measure)
  • Macular function using Microperimetry [ Time Frame: baseline to 48 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to 48 weeks ] [ Designated as safety issue: No ]
    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
Same as current
Complete list of historical versions of study NCT01449682 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Retinal Vein Occlusion
  • Macular Edema
  • Drug: Ozurdex
    0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies
    Other Name: Dexamethasone implant, DEX implant
  • Drug: Ozurdex
    0.7 mg intravitreal DEX implant on first visit then every 16 weeks
    Other Name: dexamethasone implant, DEX implant
  • 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
    Intervention: Drug: Ozurdex
  • Active Comparator: Ozurdex Q16 weeks
    0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks
    Intervention: Drug: Ozurdex
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
September 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01449682
IIT-287
No
Retina Macula Institute
Retina Macula Institute
Allergan
Principal Investigator: Ron P Gallemore, M.D. Ph.D Retina Macula Institute
Study Director: Behnam Sharareh, B.S Retina Macula Institute
Retina Macula Institute
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP