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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
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 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 August 20, 2014