Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD

Completed · Phase 1 · Has a placebo group

Conditions studied: Macular Degeneration

In brief

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 to AMD.

Key facts

Study ID

NCT00320775

Run by

Regeneron Pharmaceuticals

People needed

51

Starts

2005-06-01

Expected to finish

2008-08-01

Last updated by the study team

2015-03-18

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Retina Centers, PC — Tuscon, Arizona, United States
• Loma Linda University Health Care — Loma Linda, California, United States
• University of Chicago — Chicago, Illinois, United States
• Johns Hopkins Hospital School of Medicine — Baltimore, Maryland, United States
• Charlotte Eye, Ear, Nose & Throat Asssociates — Charlotte, North Carolina, United States
• Dean A. McGee Eye Institute — Oklahoma City, Oklahoma, United States
• Retina Diagnostic and Treatment Assoc., LLC — Philadelphia, Pennsylvania, United States
• Retina-Vitreous Associates, P.C. — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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