Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare visual improvement and total number of intraocular injections in eyes with macular edema following central retinal vein occlusion (CRVO)after initial treatment with Ozurdex (dexamethasone implant) or Avastin (bevacizumab).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Long Island Vitreoretinal Consultants
• Treatments: BB 1101; Bevacizumab; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Presence of central retinal vein occlusion (CRVO)

• Age 18 years or older

• ETDRS (Early Treatment Diabetic Retinopathy Study) Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/40 to 20/800

• OCT Central foveal thickness >250 microns

• Negative pregnancy test for women of childbearing potential

• Ability to provide written informed consent

• Capable of complying with study protocol

Exclusion Criteria:

• History of glaucoma in the study eye with intraocular pressure >21mmHg on more than one topical medication. Combination drugs are considered more than one medication

• History of steroid-related glaucoma (steroid response)

• Previous intraocular injection of steroid medication within 90 days

• Avastin (bevacizumab) or Lucentis (ranibizumab) within 60 days

• Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician

• Previous intraocular surgery (e.g. Cataract Surgery) with in 60 days

• Concurrent ocular disease that would limit visual acuity in the opinion of the treating physician

• Dense cataract that precludes clinical examination and retinal imaging of the retina

• History of allergy to dexamethasone, bevacizumab, betadine

• Ocular or systemic conditions that may pose a threat to the health of the subject in the opinion of the treating physician

• Unwilling or unable to follow or comply with all study related procedures

• Current participation in another clinical medical investigation or trial or has received any investigational drug within 12 weeks prior to enrollment