This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals Identifier:
First received: September 6, 2007
Last updated: June 10, 2013
Last verified: June 2013
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 Intervention Phase
Macular Degeneration Drug: VEGF Trap Eye Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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:
  • 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).

  • 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.

Enrollment: 157
Study Start Date: August 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) Drug: VEGF Trap Eye
Intravitreal injection
Other Name: IVT

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).

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00527423

  Show 33 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT00527423     History of Changes
Other Study ID Numbers: VGFT-OD-0702
Study First Received: September 6, 2007
Results First Received: November 2, 2012
Last Updated: June 10, 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 processed this record on June 23, 2017