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

Phase 1

Completed

• Conditions: Geographic Atrophy
• Interventions: Drug: FCFD4514S

• Registration Number: NCT00973011
• Lead Sponsor: Genentech, Inc.

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 FCFD4514S in patients with Geographic Atrophy (GA).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-08
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	FCFD4514S	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of the study drug	Through study completion or early study discontinuation

Secondary Outcome Measures

Name	Time	Method
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