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

This study has been completed.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: September 8, 2009
Last updated: February 2, 2012
Last verified: February 2012
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 Intervention Phase
Geographic Atrophy
Drug: FCFD4514S
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of the study drug [ Time Frame: Through study completion or early study discontinuation ]

Secondary Outcome Measures:
  • PK parameters of study drug (total exposure, maximum observed serum concentration, and time of maximum observed serum concentration) [ Time Frame: Through study completion or early study discontinuation ]

Enrollment: 18
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: FCFD4514S
Intravitreal escalating dose


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00973011

Sponsors and Collaborators
Genentech, Inc.
Study Director: Erich Strauss, M.D. Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc. Identifier: NCT00973011     History of Changes
Other Study ID Numbers: CFD4711g
Study First Received: September 8, 2009
Last Updated: February 2, 2012

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Geographic Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases processed this record on May 25, 2017