Overview

This trial is active, not recruiting.

Conditions retinal vein occlusion, macular edema
Treatments intravitreal injection of bevacizumab, intravitreal injection of ranibizumab (0.5 mg per dose)
Sponsor Barnes Retina Institute
Collaborator Retina Associates of Florida, P.A.
Start date September 2011
End date May 2014
Trial size 150 participants
Trial identifier NCT01428388, CRAVE1

Summary

Antagonists of the vascular endothelial growth factor (VEGF) pathway are effective in treating macular edema resulting from retinal vein occlusion (RVO). In the eye, the two most widely used anti-VEGF agents are ranibizumab and bevacizumab. Only ranibizumab has been FDA-approved for the treatment of macular edema from RVO, however bevacizumab has been used off-label by many ophthalmologists with good success. Furthermore, the cost of bevacizumab is less than one-tenth the cost of ranibizumab. Here the investigators conduct a six month randomized, prospective interventional trial comparing the effectiveness of ranibizumab with bevacizumab in the treatment of macular edema from RVO. Primary outcome measures are change in central retinal thickness. Secondary measures are change in visual acuity from baseline and change in angiographic properties of macular lesions from baseline after treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
intravitreal injection of bevacizumab
1.25 mg per dose, delivered monthly by intravitreal injection for six months
(Active Comparator)
intravitreal injection of ranibizumab (0.5 mg per dose)
0.5 mg per dose, delivered monthly by intravitreal injection for six months

Primary Outcomes

Measure
change in central retinal thickness
time frame: six months compared to baseline

Secondary Outcomes

Measure
change in best-corrected Snellen visual acuity
time frame: six months compared to baseline
change in fluorescein angiogram
time frame: six months compared to baseline

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - Ability to provide informed consent - Visual acuity of 20/40 - 20/320 in the study eye (regardless of relative APD) - Central foveal thickness (CFT) of > 250 microns as assessed by OCT (see below) - Diagnosis of retinal vein occlusion in the past 9 months - Age over 50 years Exclusion Criteria: - History of previous intraocular surgery in the study eye, including pars plana vitrectomy (but not including uncomplicated cataract surgery), within 60 days of the screening visit - Inability to make study visits - Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg) despite treatment with two or more topical pharmacological anti-glaucomatous medication) - Pregnancy or lactation - Evidence of any diabetic retinopathy on exam or history of diabetic macular edema within 12 weeks of study onset - Any intravitreal injections within 12 weeks of study onset - Prior retinal vein occlusion - History of pan-retinal photocoagulation within 3 months of study onset or anticipated within 4 months after study onset - History of cerebrovascular event or myocardial infarction within 3 months of study onset

Additional Information

Official title Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Barnes Retina Institute.