Status:
COMPLETED
A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
Lead Sponsor:
Genentech, Inc.
Conditions:
Geographic Atrophy
Eligibility:
All Genders
60-89 years
Phase:
PHASE2
Brief Summary
This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered month...
Eligibility Criteria
Inclusion
- Willingness and ability to provide signed Informed Consent; in addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws
- Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)
Exclusion
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
- Previous subfoveal focal laser photocoagulation in the study eye
- Laser photocoagulation in the study eye
- Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- GA in either eye due to causes other than AMD
- Diabetic retinopathy in either eye
- Active or history of wet AMD in either eye
- History of other disease, metabolic dysfunction, 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
- Active malignancy or history of malignancy within the past 5 years
- Previous participation in any studies of investigational drugs within 3 months preceding Day 0
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01229215
Start Date
February 1 2011
End Date
April 1 2013
Last Update
November 2 2016
Active Locations (36)
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1
Tucson, Arizona, United States, 85704
2
Beverly Hills, California, United States, 90211
3
San Francisco, California, United States, 94107
4
Santa Barbara, California, United States, 93103