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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00527423
First Posted: September 10, 2007
Last Update Posted: June 12, 2013
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.
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
  Purpose
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 (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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


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

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00527423     History of Changes
Other Study ID Numbers: VGFT-OD-0702
First Submitted: September 6, 2007
First Posted: September 10, 2007
Results First Submitted: November 2, 2012
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:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases