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

NCT00973011 | Completed Phase 1

• 1 other identifier: CFD4711g
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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

Keywords

GA

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of the study drug

  Through study completion or early study discontinuation

Secondary Outcomes (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

Study Arms (1)

A

EXPERIMENTAL

Drug: FCFD4514S

Interventions

FCFD4514S DRUG

Intravitreal escalating dose

A

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Erich Strauss, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 13, 2022

Record last verified: 2022-12