Back to resultsA Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
Primary Purpose
Geographic Atrophy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
FCFD4514S
Sponsored by
About this trial
This is an interventional treatment trial for Geographic Atrophy focused on measuring GA
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability of the study drug
Secondary Outcome Measures
PK parameters of study drug (total exposure, maximum observed serum concentration, and time of maximum observed serum concentration)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00973011
Brief Title
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
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 Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy
Keywords
GA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FCFD4514S
Intervention Description
Intravitreal escalating dose
Primary Outcome Measure Information:
Title
Safety and tolerability of the study drug
Time Frame
Through study completion or early study discontinuation
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erich Strauss, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy
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