Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion
Part of paid clinical trials in St Louis, Missouri.
- Sponsor
- Barnes Retina Institute
- Study ID
- NCT01428388
- Status
- Completed
Conditions
- Macular Edema
- Retinal Vein Occlusion
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Intravitreal injection of bevacizumab — DRUG1.25 mg per dose, delivered monthly by intravitreal injection for six months
- Intravitreal injection of ranibizumab (0.5 mg per dose) — DRUG0.5 mg per dose, delivered monthly by intravitreal injection for six months
Study Details
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.
Key Dates
- First listed
- Sep 5, 2011
- Start date
- Sep 30, 2011
- Status verified
- Oct 2017
- Primary completion
- Oct 31, 2015
- Completion
- Dec 31, 2015
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Bevacizumab
- Active Comparator: Ranibizumab
Primary Outcome Measure
change in central retinal thickness [ Time Frame: six months compared to baseline ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Retina Institute | St Louis | Missouri | 63110 | - |
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