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.
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 had subjects receive one of two doses of VEGF Trap (0.15 mg or 4.0 mg). This is the first study in which human subjects received intravitreal injections of VEGF Trap in a study eye.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Part A: Six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. Part B: Up to 30 subjects will be randomly assigned in a 1:1 ratio to receive a single of 2.0 mg/eye VEGF Trap followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Part C: Approximately 30 subjects will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. After completion of Visit 8 (Day 57), patients from all parts of the study, may be eligible to continue in Open-label Extension and will receive 4.0 mg of VEGF Trap.
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
Safety and tolerability, bioeffect
Time frame: From baseline to Day 43
The effect of VEGF Trap administration on excess central retinal/lesion thickness
Time frame: From baseline to Day 43
Best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity
Time frame: From baseline to Day 43
Extent of CNV leakage
Time frame: From baseline to Day 43
Anti-VEGF Trap antibodies in the systemic circulation
Time frame: From baseline to Day 43
Plasma levels of VEGF Trap
Time frame: From baseliene to Day 43
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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