Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD
A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration
1 other identifier
interventional
157
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2007
Typical duration for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 6, 2007
CompletedFirst Posted
Study publicly available on registry
September 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedResults Posted
Study results publicly available
June 12, 2013
CompletedJune 12, 2013
June 1, 2013
4.2 years
September 6, 2007
November 2, 2012
June 10, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AE)
Number of participants with AEs summarized by category
Baseline of this study to Wk 152
Secondary Outcomes (2)
Frequency (Number of Injections)
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
Baseline of original study to Wk 156
Study Arms (1)
Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)
EXPERIMENTALInterventions
Intravitreal injection
Eligibility Criteria
You may qualify if:
- Prior participation in VEGF Trap-Eye Phase I and II studies
You may not qualify if:
- Any ocular or systemic adverse events that would preclude participation
- Presence of any condition that would jeopardize subject's participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalslead
- Bayercollaborator
Study Sites (33)
Unknown Facility
Peoria, Arizona, 85381, United States
Unknown Facility
Phoenix, Arizona, 85020, United States
Unknown Facility
Tucson, Arizona, 85704, United States
Unknown Facility
Beverly Hills, California, 90211, United States
Unknown Facility
Loma Linda, California, 92354, United States
Unknown Facility
Palm Springs, California, 92262, United States
Unknown Facility
Pasadena, California, 91105, United States
Unknown Facility
Poway, California, 92064, United States
Unknown Facility
Westlake Village, California, 91361, United States
Unknown Facility
Fort Myers, Florida, 33912, United States
Unknown Facility
Stuart, Florida, 34994, United States
Unknown Facility
Winter Haven, Florida, 33880, United States
Unknown Facility
Augusta, Georgia, 30909, United States
Unknown Facility
Glenview, Illinois, 60026, United States
Unknown Facility
Indianapolis, Indiana, 47280, United States
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
Hagerstown, Maryland, 21740, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
West Springfield, Massachusetts, 01089, United States
Unknown Facility
Toms River, New Jersey, 08755, United States
Unknown Facility
Lynbrook, New York, 11563, United States
Unknown Facility
Charlotte, North Carolina, 28210, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
West Columbia, South Carolina, 29169, United States
Unknown Facility
Rapid City, South Dakota, 57701, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Fort Worth, Texas, 76102, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
McAllen, Texas, 78503, United States
Unknown Facility
San Antonio, Texas, 78240, United States
Unknown Facility
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials Administrator
- Organization
- Regeneron Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2007
First Posted
September 10, 2007
Study Start
August 1, 2007
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
June 12, 2013
Results First Posted
June 12, 2013
Record last verified: 2013-06