Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion (CRAVE)

Barnes Retina Institute

Status

Completed

Conditions

Macular Edema

Retinal Vein Occlusion

Treatments

Drug: Intravitreal injection of bevacizumab

Drug: Intravitreal injection of ranibizumab (0.5 mg per dose)

Study type

Interventional

Funder types

Other

Identifiers

NCT01428388

CRAVE1

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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