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

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ClinicalTrials.gov Identifier: NCT00527423
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : June 12, 2013
Last Update Posted : June 12, 2013
Sponsor:
Collaborator:
Bayer
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: N/A
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.



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

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 ClinicalTrials.gov identifier (NCT number): NCT00527423


Locations
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United States, Arizona
Peoria, Arizona, United States, 85381
Phoenix, Arizona, United States, 85020
Tucson, Arizona, United States, 85704
United States, 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
United States, Florida
Ft. Myers, Florida, United States, 33912
Stuart, Florida, United States, 34994
Winter Haven, Florida, United States, 33880
United States, Georgia
Augusta, Georgia, United States, 30909
United States, Illinois
Glenview, Illinois, United States, 60026
United States, Indiana
Indianapolis, Indiana, United States, 47280
United States, Maryland
Baltimore, Maryland, United States, 21287
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Boston, Massachusetts, United States, 02114
West Springfield, Massachusetts, United States, 01089
United States, New Jersey
Toms River, New Jersey, United States, 08755
United States, New York
Lynbrook, New York, United States, 11563
United States, North Carolina
Charlotte, North Carolina, United States, 28210
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Portland, Oregon, United States, 97210
United States, South Carolina
W. Columbia, South Carolina, United States, 29169
United States, South Dakota
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, 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
United States, Utah
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Regeneron Pharmaceuticals
Bayer
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00527423    
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
AMD
Neovascular Age-Related Macular Degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases