A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
NCT ID: NCT00973011
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
2009-09-30
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
FCFD4514S
Intravitreal escalating dose
Interventions
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FCFD4514S
Intravitreal escalating dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
50 Years
85 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Erich Strauss, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Countries
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Other Identifiers
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CFD4711g
Identifier Type: -
Identifier Source: org_study_id