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Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion

NCT ID: NCT01428388

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Retinal Vein Occlusion Macular Edema

Keywords

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macular edema vein occlusion bevacizumab ranibizumab vascular endothelial growth factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bevacizumab

Group Type ACTIVE_COMPARATOR

Intravitreal injection of bevacizumab

Intervention Type DRUG

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

Ranibizumab

Group Type ACTIVE_COMPARATOR

Intravitreal injection of ranibizumab (0.5 mg per dose)

Intervention Type DRUG

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

Interventions

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Intravitreal injection of bevacizumab

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

Intervention Type DRUG

Intravitreal injection of ranibizumab (0.5 mg per dose)

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Retina Associates of Florida, P.A.

OTHER

Sponsor Role collaborator

Illinois Retina Associates

OTHER

Sponsor Role collaborator

Kresge Eye Institute

OTHER

Sponsor Role collaborator

Long Island Vitreoretinal Consultants

OTHER

Sponsor Role collaborator

Mid Atlantic Retina

OTHER

Sponsor Role collaborator

Retina Associates, Kansas City

OTHER

Sponsor Role collaborator

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role collaborator

Barnes Retina Institute

OTHER

Sponsor Role lead

Responsible Party

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Rhonda Weeks

Gaurav Shah, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Retina Institute

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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Rajagopal R, Shah GK, Blinder KJ, Altaweel M, Eliott D, Wee R, Cooper B, Walia H, Smith BT, Joseph DP. Bevacizumab Versus Ranibizumab in the Treatment of Macular Edema Due to Retinal Vein Occlusion: 6-Month Results of the CRAVE Study. Ophthalmic Surg Lasers Imaging Retina. 2015 Sep;46(8):844-50. doi: 10.3928/23258160-20150909-09.

Reference Type DERIVED
PMID: 26431300 (View on PubMed)

Other Identifiers

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CRAVE1

Identifier Type: -

Identifier Source: org_study_id