A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy

Completed · Phase 2 · Has a placebo group

Conditions studied: Geographic Atrophy

In brief

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 monthly or every other month in patients with geographic atrophy.

Key facts

Study ID

NCT01229215

Run by

Genentech, Inc.

People needed

143

Starts

2011-02-01

Expected to finish

2013-04-01

Last updated by the study team

2016-11-02

Who can join

Age: 60 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — San Francisco, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Torrance, California, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Palm Beach Gardens, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Winter Haven, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Paducah, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Edina, Minnesota, United States
• Study site — Lynbrook, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Beachwood, Ohio, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — West Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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