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

June 10, 2013 updated by: Regeneron Pharmaceuticals

A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
      • Phoenix, Arizona, United States, 85020
      • Tucson, Arizona, United States, 85704
    • California
      • Beverly Hills, California, United States, 90211
      • Loma Linda, California, United States, 92354
      • Palm Springs, California, United States, 92262
      • Pasadena, California, United States, 91105
      • Poway, California, United States, 92064
      • Westlake Village, California, United States, 91361
    • Florida
      • Ft. Myers, Florida, United States, 33912
      • Stuart, Florida, United States, 34994
      • Winter Haven, Florida, United States, 33880
    • Georgia
      • Augusta, Georgia, United States, 30909
    • Illinois
      • Glenview, Illinois, United States, 60026
    • Indiana
      • Indianapolis, Indiana, United States, 47280
    • Maryland
      • Baltimore, Maryland, United States, 21287
      • Hagerstown, Maryland, United States, 21740
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • West Springfield, Massachusetts, United States, 01089
    • New Jersey
      • Toms River, New Jersey, United States, 08755
    • New York
      • Lynbrook, New York, United States, 11563
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Portland, Oregon, United States, 97210
    • South Carolina
      • W. Columbia, South Carolina, United States, 29169
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78705
      • Fort Worth, Texas, United States, 76102
      • Houston, Texas, United States, 77030
      • McAllen, Texas, United States, 78503
      • San Antonio, Texas, United States, 78240
    • Utah
      • Salt Lake City, Utah, United States, 84107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)
Drug: VEGF Trap Eye
Intravitreal injection
Other Names:
  • IVT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AE)
Time Frame: Baseline of this study to Wk 152
Number of participants with AEs summarized by category
Baseline of this study to Wk 152

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency (Number of Injections)
Time Frame: Baseline of this study to Wk 152
Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).
Baseline of this study to Wk 152
Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values
Time Frame: Baseline of original study to Wk 156
Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning.
Baseline of original study to Wk 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 6, 2007

First Submitted That Met QC Criteria

September 7, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 10, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGFT-OD-0702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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