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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Retinal Vein Occlusion
Macular Edema
 Drug: Ozurdex
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of an Intravitreal Dexamethasone Implant on Macular Function in Retinal Vein Occlusion Following Treatment With Intravitreal Anti-VEGF Injections.

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Retina Macula Institute:

Primary Outcome Measures:
  • 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


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 [ 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 ]

Estimated Enrollment: 10
Study Start Date: October 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 every 16 weeks
Other Name: dexamethasone implant, DEX implant

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449682

Locations
United States, California
Retina Macula Institute
Torrance, California, United States, 90503
Sponsors and Collaborators
Retina Macula Institute
Allergan
Investigators
Principal Investigator: Ron P Gallemore, M.D. Ph.D Retina Macula Institute
Study Director: Behnam Sharareh, B.S Retina Macula Institute
  More Information

No publications provided

Responsible Party: Retina Macula Institute
ClinicalTrials.gov Identifier: NCT01449682     History of Changes
Other Study ID Numbers: IIT-287
Study First Received: October 6, 2011
Last Updated: January 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Retina Macula Institute:
BRVO
CRVO
Macular Edema
Anti-VEGF
Ozurdex

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Dexamethasone acetate
Dexamethasone
 Dexamethasone 21-phosphate
Bevacizumab
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 16, 2013