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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00527423
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : June 12, 2013
Last Update Posted : June 12, 2013
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: VEGF Trap Eye Phase 2

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  (Clinical Trial)
Actual Enrollment : 157 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration
Study Start Date : August 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) Drug: VEGF Trap Eye
Intravitreal injection
Other Name: IVT

Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AE) [ Time Frame: Baseline of this study to Wk 152 ]
    Number of participants with AEs summarized by category

Secondary Outcome Measures :
  1. 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).

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00527423

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Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT00527423     History of Changes
Other Study ID Numbers: VGFT-OD-0702
First Posted: September 10, 2007    Key Record Dates
Results First Posted: June 12, 2013
Last Update Posted: June 12, 2013
Last Verified: June 2013

Keywords provided by Regeneron Pharmaceuticals:
VEGF Trap-Eye
Macular Degeneration
Neovascular Age-Related Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases