Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

Not Applicable

Completed

• Conditions: Macular Edema; Retinal Vein Occlusion
• Interventions: Drug: Intravitreal injection of bevacizumab; Drug: Intravitreal injection of ranibizumab (0.5 mg per dose)

• Registration Number: NCT01428388
• Lead Sponsor: Barnes Retina Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-02
• Study First Posted: 2011-09-05
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bevacizumab	Intravitreal injection of bevacizumab	-
Ranibizumab	Intravitreal injection of ranibizumab (0.5 mg per dose)	-

Primary Outcome Measures

Name	Time	Method
change in central retinal thickness	six months compared to baseline	central thickness is measured using optical coherence tomography (OCT)

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Retina Institute; 🇺🇸 Saint Louis, Missouri, United States