CRAVE: Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

Sponsor

Barnes Retina Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01428388

Collaborator

Retina Associates of Florida, P.A. (Other), Illinois Retina Associates (Other), Kresge Eye Institute (Other), Long Island Vitreoretinal Consultants (Other), Mid Atlantic Retina (Other), Retina Associates, Kansas City (Other), Massachusetts Eye and Ear Infirmary (Other)

150

Enrollment

Location

Arms

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion Macular Edema	Drug: Intravitreal injection of bevacizumab Drug: Intravitreal injection of ranibizumab (0.5 mg per dose)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bevacizumab	Drug: Intravitreal injection of bevacizumab 1.25 mg per dose, delivered monthly by intravitreal injection for six months
Active Comparator: Ranibizumab	Drug: Intravitreal injection of ranibizumab (0.5 mg per dose) 0.5 mg per dose, delivered monthly by intravitreal injection for six months

Arm

Intervention/Treatment

Active Comparator: Bevacizumab

Drug: Intravitreal injection of bevacizumab

1.25 mg per dose, delivered monthly by intravitreal injection for six months

Active Comparator: Ranibizumab

Drug: Intravitreal injection of ranibizumab (0.5 mg per dose)

0.5 mg per dose, delivered monthly by intravitreal injection for six months

Outcome Measures

Primary Outcome Measures

change in central retinal thickness [six months compared to baseline]
central thickness is measured using optical coherence tomography (OCT)

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

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