Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Barnes Retina Institute
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- change in central retinal thickness
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Ranibizumab
Intervention: Intravitreal injection of ranibizumab (0.5 mg per dose) (Drug)
Bevacizumab
Intervention: Intravitreal injection of bevacizumab (Drug)
Outcomes
Primary Outcomes
change in central retinal thickness
Time Frame: six months compared to baseline
central thickness is measured using optical coherence tomography (OCT)
Secondary Outcomes
- change in best-corrected Snellen visual acuity(six months compared to baseline)
- change in fluorescein angiogram(six months compared to baseline)
Investigators
Rhonda Weeks
Gaurav Shah, MD
Barnes Retina Institute