Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

NCT ID: NCT00943072

Last Updated: 2013-05-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-04-30

Brief Summary

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This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.

Detailed Description

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Conditions

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Macular Edema Secondary to Central Retinal Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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VEGF Trap-Eye

Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint

Group Type EXPERIMENTAL

VEGF Trap-Eye 2.0mg

Intervention Type BIOLOGICAL

Monthly intravitreal injection out to the Week 24 Primary endpoint

Sham

Monthly Sham IVT injection until Week 24 Primary Endpoint

Group Type SHAM_COMPARATOR

Sham

Intervention Type DRUG

Monthly sham intravitreal injection out to Week 24 Primary Endpoint

Interventions

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VEGF Trap-Eye 2.0mg

Monthly intravitreal injection out to the Week 24 Primary endpoint

Intervention Type BIOLOGICAL

Sham

Monthly sham intravitreal injection out to Week 24 Primary Endpoint

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects at least 18 years of age with center-involved macular edema secondary to CRVO with mean central retinal thickness ≥ 250 μm on OCT
* ETDRS best corrected visual acuity of 20/40 to 20/320 (73 to 24 letters) in the study eye

Exclusion Criteria

* Previous treatment with anti-angiogenic drugs in the study eye (Pegaptanib sodium,anecortave acetate, bevacizumab, ranibizumab, etc.)
* Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
* CRVO disease duration \> 9 months from date of diagnosis
* Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
* Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Arcadia, California, United States

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Beverly Hills, California, United States

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La Jolla, California, United States

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Mountain View, California, United States

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Oakland, California, United States

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Sacramento, California, United States

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Torrance, California, United States

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New London, Connecticut, United States

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Altamonte Springs, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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Palm Beach Gardens, Florida, United States

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Winter Haven, Florida, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Wichita, Kansas, United States

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Baltimore, Maryland, United States

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Hagerstown, Maryland, United States

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Towson, Maryland, United States

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Boston, Massachusetts, United States

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Grand Rapids, Michigan, United States

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Jackson, Michigan, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Northfield, New Jersey, United States

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Toms River, New Jersey, United States

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Rochester, New York, United States

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Winston-Salem, North Carolina, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Salem, Oregon, United States

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Kingston, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Columbia, South Carolina, United States

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Rapid City, South Dakota, United States

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Nashville, Tennessee, United States

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Abilene, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Mississauga, Ontario, Canada

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Toronto, Ontario, Canada

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Medellín, Antioquia, Colombia

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Bogotá, , Colombia

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Hyderabad, A.p., India

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Bangalore, Karnataka, India

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Kolkata, West Bengal, India

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Kfar Saba, Israel, Israel

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Petah Tikva, Israel, Israel

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Rehovot, Israel, Israel

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Tel Aviv, Israel, Israel

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Countries

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United States Canada Colombia India Israel

Other Identifiers

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VGFT-OD-0819

Identifier Type: -

Identifier Source: org_study_id

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