Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion
Status: | Completed |
---|---|
Conditions: | Cardiology, Ocular |
Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 10/29/2017 |
Start Date: | September 2011 |
End Date: | December 2015 |
Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion
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.
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.
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
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