Status:
COMPLETED
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
Lead Sponsor:
Genentech, Inc.
Conditions:
Geographic Atrophy
Eligibility:
All Genders
50-85 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00973011
Start Date
September 1 2009
End Date
July 1 2010
Last Update
December 13 2022
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