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



Status:Completed
Healthy:No
Age Range:60 - 89
Updated:8/3/2016
Start Date:February 2011
End Date:April 2013

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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 to Patients With Geographic Atrophy

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.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
30
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Beverly Hills, California 90211
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Charlotte, North Carolina 28207
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Palm Beach Gardens, Florida 33410
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Santa Barbara, California 93105
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West Columbia, South Carolina 29169
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Winter Haven, FL
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