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

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ClinicalTrials.gov Identifier: NCT00973011
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : February 6, 2012
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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 : September 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: FCFD4514S
Intravitreal escalating dose


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

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973011


Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Erich Strauss, M.D. Genentech, Inc.
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00973011     History of Changes
Other Study ID Numbers: CFD4711g
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012

Keywords provided by Genentech, Inc.:
GA

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