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

NCT ID: NCT00973011

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-07-31

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).

Conditions

Geographic Atrophy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

FCFD4514S

Intervention Type: DRUG

Intravitreal escalating dose

Interventions

FCFD4514S

Intravitreal escalating dose

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erich Strauss, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

CFD4711g

Identifier Type: -

Identifier Source: org_study_id