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

Long Island Vitreoretinal Consultants

Status: Completed

Conditions: Macular Edema; Central Retinal Vein Occlusion

Treatments: Drug: Ozurdex; Drug: Avastin

Study type: Interventional

Funder types: Other

Identifiers

NCT01231633

IST CRVO 1118147

Details and patient eligibility

About

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).

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups

Group 1

Experimental group

Description:

Subjects randomized to this arm will receive one initial treatment with Ozurdex then treated with Avastin if needed.

Treatment:

Drug: Avastin

Drug: Ozurdex

Group 2

Active Comparator group

Description:

Subjects randomized to this arm will receive one initial treatment with Avastin then treated with Avastin if needed.

Treatment:

Drug: Avastin