Macular Edema, Retinal Vein Occlusion
Conditions
Keywords
macular edema, vein occlusion, bevacizumab, ranibizumab, vascular endothelial growth factor
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.
Interventions
1.25 mg per dose, delivered monthly by intravitreal injection for six months
DRUGIntravitreal injection of ranibizumab (0.5 mg per dose)
0.5 mg per dose, delivered monthly by intravitreal injection for six months
Sponsors
Retina Associates of Florida, P.A.
Illinois Retina Associates
Kresge Eye Institute
Long Island Vitreoretinal Consultants
Mid Atlantic Retina
Retina Associates, Kansas City
Massachusetts Eye and Ear Infirmary
Barnes Retina Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in central retinal thickness | six months compared to baseline | central thickness is measured using optical coherence tomography (OCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in best-corrected Snellen visual acuity | six months compared to baseline | 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. |
| change in fluorescein angiogram | six months compared to baseline | fluorescein angiograms will measure area of peripheral nonperfusion. This will be interpreted by a designated physician at each testing center. |
Countries
United States
Outcome results
None listed