Status:
COMPLETED
Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Bayer
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The primary objective is to assess long-term safety and tolerability of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.
Detailed Description
The dose evaluated in this study, Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg, will be the higher of the 2 dose strengths evaluated in parent study VGFT-OD-0605 (NCT00509795) and ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
323 Patients enrolled
Trial Details
Trial ID
NCT00964795
Start Date
December 1 2009
End Date
August 1 2013
Last Update
March 23 2015
Active Locations (124)
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1
Birmingham (2 Locations), Alabama, United States
2
Phoenix (2 Locations), Arizona, United States
3
Tucson (2 Locations), Arizona, United States
4
Arcadia, California, United States