Clinical trial NCT01231633: Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
Official title: Comparative Study of Initial Ozurdex (Dexamethasone Implant) Versus Avastin (Bevacizumab) in the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Edema
Central Retinal Vein Occlusion
Keywords: Macular Edema
Central Retinal Vein Occlusion
Lead sponsor: Long Island Vitreoretinal Consultants
Sponsor class: OTHER
First posted: 2010-11-01
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: The Change in Visual Acuity (Number of ETDRS Early Treatment Diabetic Retinopathy Study Letters), at Month 6 as Compared With Baseline in Each Treatment Arm
timeFrame: Baseline - Month 6
measure: The Total Number of Additional Avastin Injections Following Initial Treatment in Each Treatment Arm
timeFrame: Baseline - Month 6
Secondary outcomes:
measure: Change in Central Mean Thickness Based on OCT
timeFrame: Baseline to 6 Months
Other outcomes:
Locations:
city: Toms River
country: United States
facility: Retina Vitreous Center
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: Hauppauge
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: Riverhead
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
Study officials:
affiliation: Long Island Vitreoretinal Consultants
name: Vincent A Deramo, M.D
role: PRINCIPAL_INVESTIGATOR
References: