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

Phase 2

Completed

• Conditions: Geographic Atrophy
• Interventions: Drug: FCFD4514S; Drug: sham

• Registration Number: NCT01229215
• Lead Sponsor: Genentech, Inc.

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 monthly or every other month in patients with geographic atrophy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-27
• Study Start: 2011-02
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Disposition First Submitted: 2016-08-10
• Disposition First Submitted QC: 2016-08-10
• Disposition First Posted: 2016-08-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FCFD4514S	FCFD4514S	-
sham	sham	-

Primary Outcome Measures

Name	Time	Method
Growth rate of geographic atrophy (GA) lesion area from baseline	Month 18

Secondary Outcome Measures

Name	Time	Method
Mean change in best corrected visual acuity (BCVA) from baseline	Month 18