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

Genentech

Status and phase: Completed; Phase 2

Conditions: Geographic Atrophy

Treatments: Drug: FCFD4514S; Drug: sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT01229215

CFD4870g

GX01456 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 60 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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143 participants in 2 patient groups

FCFD4514S

Experimental group

Treatment:

Drug: FCFD4514S

sham

Sham Comparator group

Treatment:

Drug: sham