Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

Barnes Retina Institute150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Retinal Vein Occlusion Macular Edema

Interventions

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change in central retinal thickness

central thickness is measured using optical coherence tomography (OCT)

Time frame: six months compared to baseline

Secondary Outcomes

change in best-corrected Snellen visual acuity

best-corrected Snellen visual acuity (BCVA) is the best visual acuity measured using a standard Snellen eye chart at 20 feet between (1) uncorrected vision, (2) vision with current eyeglasses or (3) pinholed visual acuity.

Time frame: six months compared to baseline

change in fluorescein angiogram

fluorescein angiograms will measure area of peripheral nonperfusion. This will be interpreted by a designated physician at each testing center.

Time frame: six months compared to baseline

Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes