Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Barnes Retina Institute
• Collaborators: Illinois Retina Associates; Kresge Eye Institute; Long Island Vitreoretinal Consultants; Massachusetts Eye and Ear Infirmary; Mid Atlantic Retina; Retina Associates of Florida, P.A.; Retina Associates, Kansas City
• Treatments: Bevacizumab; Endothelial Growth Factors; Ranibizumab

Criteria

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