Extension Study of the Use of Vascular Endothelial Growth Factor (VEGF) Trap-Eye in Neovascular Age-Related Macular Degeneration (AMD)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00964795
First received: August 20, 2009
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

The primary objective is to assess long-term safety and tolerability of VEGF Trap-Eye in patients with neovascular AMD.


Condition Intervention Phase
Neovascular Age-related Macular Degeneration
Drug: VEGF Trap-Eye
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Long-term, Safety and Tolerability Extension Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Assess long-term safety and tolerability via complete eye exam and collection of AE data [ Time Frame: day 1 to week 180 ] [ Designated as safety issue: Yes ]
    The primary endpoint in the study is the safety and tolerability of VEGF Trap-Eye in patients with neovascular AMD from day 1 through the end of treatment visit (week 180).


Secondary Outcome Measures:
  • Change in best corrected visual acuity (BCVA) [ Time Frame: day 1 to week 180 ] [ Designated as safety issue: No ]
    The secondary endpoint in the study is the change in BCVA from day 1 through the end of treatment visit (week 180).


Enrollment: 323
Study Start Date: December 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
VEGF Trap-Eye administered via method 1
Drug: VEGF Trap-Eye
Study drug will be administered at the discretion of the investigator with a minimal interval of every 4 weeks and at every 8 weeks
Other Names:
  • EYLEA
  • Intravitreal Aflibercept Injection (IAI)
Experimental: Group 2
VEGF Trap-Eye administered via method 2
Drug: VEGF Trap-Eye
Study drug will be administered at the discretion of the investigator with a minimal interval of every 4 weeks and at every 8 weeks
Other Names:
  • EYLEA
  • Intravitreal Aflibercept Injection (IAI)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in Study VGFT-OD-0605 through week 96.
  • In the opinion of the investigator, the study eye has neovascular AMD and may continue to require treatment.

Exclusion Criteria:

  • Presence of any condition that would jeopardize the patient's participation in this study.
  • Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964795

  Show 124 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: NCT00964795     History of Changes
Other Study ID Numbers: VGFT-OD-0910
Study First Received: August 20, 2009
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Regeneron Pharmaceuticals:
Eyes
Neovascular
Macular Degeneration
Retina
AMD
VEGF Trap-Eye
Best Corrected Visual Acuity

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014