Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD

NCT ID: NCT00527423

Last Updated: 2013-06-12

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

PHASE2

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2011-10-31

Brief Summary

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Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.

Detailed Description

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Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).

Conditions

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Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)

Group Type EXPERIMENTAL

VEGF Trap Eye

Intervention Type DRUG

Intravitreal injection

Interventions

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VEGF Trap Eye

Intravitreal injection

Intervention Type DRUG

Other Intervention Names

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IVT

Eligibility Criteria

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Inclusion Criteria

* Prior participation in VEGF Trap-Eye Phase I and II studies

Exclusion Criteria

* Any ocular or systemic adverse events that would preclude participation
* Presence of any condition that would jeopardize subject's participation
Minimum Eligible Age

50 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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Peoria, Arizona, United States

Site Status

Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Beverly Hills, California, United States

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Loma Linda, California, United States

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Palm Springs, California, United States

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Pasadena, California, United States

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Poway, California, United States

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Westlake Village, California, United States

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Fort Myers, Florida, United States

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Stuart, Florida, United States

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Winter Haven, Florida, United States

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Augusta, Georgia, United States

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Glenview, Illinois, United States

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Indianapolis, Indiana, United States

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Baltimore, Maryland, United States

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Hagerstown, Maryland, United States

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Boston, Massachusetts, United States

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West Springfield, Massachusetts, United States

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Toms River, New Jersey, United States

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Lynbrook, New York, United States

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Charlotte, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Portland, Oregon, 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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Austin, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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McAllen, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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VGFT-OD-0702

Identifier Type: -

Identifier Source: org_study_id

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