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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00964795
First received: August 20, 2009
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

The primary objective is to assess long-term safety and tolerability of VEGF Trap-Eye in patients with age related macular degeneration.


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 Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:

Drug Information available for: Aflibercept
U.S. FDA Resources

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: 180 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in best corrected visual acuity from Day 1 through the end of the study [ Time Frame: 180 weeks ] [ Designated as safety issue: No ]

Enrollment: 323
Study Start Date: December 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 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 53 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: January 29, 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 May 23, 2013