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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.
Sponsor:
Genentech, Inc.
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
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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: 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 |
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 (Adult, Senior) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00973011
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
| 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 |
Keywords provided by Genentech, Inc.:
|
GA |
Additional relevant MeSH terms:
|
Atrophy Geographic Atrophy Pathological Conditions, Anatomical Macular Degeneration |
Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on September 21, 2017