Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

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.

Official Title
-----------------
Comparison of Anti-vascular Endothelial Growth Factors Agents in the Treatment of Macular Edema Following Retinal Vein Occlusion

Conditions
-----------------
Retinal Vein Occlusion, Macular Edema

Intervention / Treatment
-----------------
* Drug: Intravitreal injection of bevacizumab
* Drug: Intravitreal injection of ranibizumab (0.5 mg per dose)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bevacizumab<br> | Drug: Intravitreal injection of bevacizumab<br>* 1.25 mg per dose, delivered monthly by intravitreal injection for six months<br>|
| Active Comparator: Ranibizumab<br> | Drug: Intravitreal injection of ranibizumab (0.5 mg per dose)<br>* 0.5 mg per dose, delivered monthly by intravitreal injection for six months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in central retinal thickness | central thickness is measured using optical coherence tomography (OCT) | six months compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in best-corrected Snellen visual acuity | 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. | six months compared to baseline | 
| change in fluorescein angiogram | fluorescein angiograms will measure area of peripheral nonperfusion. This will be interpreted by a designated physician at each testing center. | six months compared to baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular edema, vein occlusion, bevacizumab, ranibizumab, vascular endothelial growth factor