Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00973011
First received: September 8, 2009
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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

  Eligibility
Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973011

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

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00973011     History of Changes
Other Study ID Numbers: CFD4711g
Study First Received: September 8, 2009
Last Updated: February 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
GA

Additional relevant MeSH terms:
Atrophy
Geographic Atrophy
Eye Diseases
Macular Degeneration
 Pathological Conditions, Anatomical
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on March 03, 2015