Overview

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

Status:
Completed
Trial end date:
2013-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Retina Macula Institute
Collaborator:
Allergan
Treatments:
BB 1101
Bevacizumab
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
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.