A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The Phase Ia, open-label, multicenter study will consist of a single-dose, dose-escalation study of the safety, tolerability, pharmacokinetics, and immunogenicity of an intravitreal (ITV) injection of FCFD4514S in patients with Geographic Atrophy (GA).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

Inclusion Criteria:

• Ability and willingness to undertake all scheduled visits and assessments

• Agreement to use an effective form of contraception for the duration of the study

• Geographic atrophy (GA) at least 0.75 disc areas in the absence of choroidal neovascularization (CNV)

Exclusion Criteria:

• Treatment for active systemic infection

• Predisposition or history of increased risk for infection

• Active malignancy

• History of medical conditions, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications

• GA in either eye due to non-AMD causes

• Active or history of ocular and intraocular conditions in the study eye (except GA)

• History of vitreoretinal surgery or laser photocoagulation in the study eye

• Prior treatment for AMD (except vitamins and minerals)

• History of intravitreal (ITV) drug delivery

• Intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 0

• Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)