Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)

Completed · Phase 2

Conditions studied: Macular Degeneration

In brief

This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD. The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

Key facts

Study ID

NCT00320788

Run by

Regeneron Pharmaceuticals

People needed

159

Starts

2006-04-01

Expected to finish

2008-08-01

Last updated by the study team

2012-03-01

Who can join

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

You may qualify if…

• Subfoveal CNV secondary to AMD.
• Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography (OCT).
• Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters.

You may not qualify if…

• History of any vitreous hemorrhage within 4 weeks prior to Day 1.
• Aphakia.
• Significant subfoveal atrophy or scarring.
• Prior treatment with the following in the study eye:
• Subfoveal thermal laser therapy.
• Submacular surgery or other surgical intervention for the treatment of AMD.
• Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1.
• Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1).
• Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1).
• Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1).
• Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy.
• Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin).
• Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.

Where it is running

• Associated Retina Consultants — Phoenix, Arizona, United States
• Retina Centers, PC — Tucson, Arizona, United States
• Retina Vitreous Associates Medical Group — Beverly Hills, California, United States
• Loma Linda University Health Care — Loma Linda, California, United States
• Southeast Retina Center — Augusta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Johns Hopkins Hospital School of Medicine — Baltimore, Maryland, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• New England Retina Consultants PC — West Springfield, Massachusetts, United States
• Charlotte Eye, Ear, Nose & Throat Asssociates — Charlotte, North Carolina, United States
• Dean A. McGee Eye Institute — Oklahoma City, Oklahoma, United States
• Retina Northwest PC — Portland, Oregon, United States
• Retina Diagnostic and Treatment Assoc., LLC — Philadelphia, Pennsylvania, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• Retina-Vitreous Associates, P.C. — Nashville, Tennessee, United States
• Vitreoretinal Consultants Scurlock Tower Texas Medical Center — Houston, Texas, United States
• Medical Center Ophthamology — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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