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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Geographic Atrophy | Drug: FCFD4514S | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: A |
Drug: FCFD4514S
Intravitreal escalating dose |
- Safety and tolerability of the study drug [ Time Frame: Through study completion or early study discontinuation ]
- 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 ]

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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 |
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)

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
Study Director: | Erich Strauss, M.D. | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT00973011 |
Other Study ID Numbers: |
CFD4711g |
First Posted: | September 9, 2009 Key Record Dates |
Last Update Posted: | February 6, 2012 |
Last Verified: | February 2012 |
GA |
Geographic Atrophy Atrophy Pathological Conditions, Anatomical Macular Degeneration |
Retinal Degeneration Retinal Diseases Eye Diseases |