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

Geographic Atrophy Clinical Trial

Official title:

A Phase Ia, Multicenter, Open-Label, Single-Dose, Dose-Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973011
• Other study ID #: CFD4711g
• Status: Completed
• Phase: Phase 1
• Start date: September 2009
• Est. completion date: July 2010

Study information

• Verified date: December 2022
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy

Intervention

Drug:
• FCFD4514S
Intravitreal escalating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of the study drug		Through study completion or early study discontinuation
Secondary	PK parameters of study drug (total exposure, maximum observed serum concentration, and time of maximum observed serum concentration)		Through study completion or early study discontinuation