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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00527423
First received: September 6, 2007
Last updated: June 10, 2013
Last verified: June 2013
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]
    Number of participants with AEs summarized by category


Secondary Outcome Measures:
  • Frequency (Number of Injections) [ Time Frame: Baseline of this study to Wk 152 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527423

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

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 15, 2014