Status:
COMPLETED
Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Bayer
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due...
Detailed Description
This study consists of three parts, Part A, Part B and Part C. Part A is a dose escalation. Part B was terminated early. The (one) subject who received Macugen is not discussed in this website. Part C...
Eligibility Criteria
Inclusion
- Subfoveal CNV secondary to AMD.
- Central retinal/lesion thickness ≥ 250µm as measured by optical coherence tomography (OCT).
- ETDRS best-corrected visual acuity of:
- 20/40 (73 letters) or worse
- Clear ocular media and clear lens(es) to permit good quality stereoscopic fundus photography.
Exclusion
- Prior treatment with VEGF Trap, bevacizumab or ranibizumab.
- Any investigational agent within 12 weeks of Visit 2 (Day 1).
- Presence of other causes of CNV.
- Active ocular infection.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00320775
Start Date
June 1 2005
End Date
August 1 2008
Last Update
March 18 2015
Active Locations (8)
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1
Retina Centers, PC
Tuscon, Arizona, United States, 85704
2
Loma Linda University Health Care
Loma Linda, California, United States, 92354
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Johns Hopkins Hospital School of Medicine
Baltimore, Maryland, United States, 21287