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

• Sponsor: Genentech, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00973011
• Collaborator: (none)
• Enrollment: 18
• Arm: 1
• Duration (Months): 10

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Geographic Atrophy	Drug: FCFD4514S	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: FCFD4514S; Intravitreal escalating dose

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability of the study drug [Through study completion or early study discontinuation]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Genentech, Inc.

Investigators

• Study Director: Erich Strauss, M.D., Genentech, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Genentech, Inc.
• ClinicalTrials.gov Identifier: NCT00973011
• Other Study ID Numbers: CFD4711g
• First Posted: Sep 9, 2009
• Last Update Posted: Feb 6, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Genentech, Inc.: GA
• Additional relevant MeSH terms: Geographic Atrophy; Atrophy

Study Results

No Results Posted as of Feb 6, 2012