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

Genentech

Status and phase

Completed

Phase 1

Conditions

Geographic Atrophy

Treatments

Drug: FCFD4514S

Study type

Interventional

Funder types

Industry

Identifiers

NCT00973011

CFD4711g

Details and patient eligibility

About

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).

Enrollment

18 patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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)