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

PHASE1CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

June 30, 2008

Study Completion Date

August 31, 2008

Conditions
Macular Degeneration
Interventions
DRUG

VEGF Trap

"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."

Trial Locations (8)

19107

Retina Diagnostic and Treatment Assoc., LLC, Philadelphia

21287

Johns Hopkins Hospital School of Medicine, Baltimore

28120

Charlotte Eye, Ear, Nose & Throat Asssociates, Charlotte

37203

Retina-Vitreous Associates, P.C., Nashville

60637

University of Chicago, Chicago

73104

Dean A. McGee Eye Institute, Oklahoma City

85704

Retina Centers, PC, Tuscon

92354

Loma Linda University Health Care, Loma Linda

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Regeneron Pharmaceuticals

INDUSTRY