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Phase 3 N=10 Randomized Double-blind Treatment

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

Retinal Vein Occlusion · Macular Edema

Bottom Line

View on ClinicalTrials.gov: NCT01449682 ↗
Enrolled (actual)
10
Serious AEs
10.0%
Results posted
May 2017
Primary outcome: Primary: Macular Function Using Microperimetry — 2.7; 12.7; 4.2; 10.7 dB

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Ozurdex (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Retina Macula Institute
Primary completion
Jul 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Macular Function Using Microperimetry		 2.7; 12.7; 4.2; 10.7 —
PRIMARY
Macular Function Using Multi-focal ERG		 3.61; 6.62; 18.20; 30.18 —
SECONDARY
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		 46.4; 55.6; 27.8; 53.2 —
SECONDARY
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		 501.7; 353.5; 361.4; 326.7 —

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01449682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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