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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 2013

Interventions

  • Drug: FCFD4514S
    • Repeating intravitreal injection
  • Drug: sham
    • Repeating sham injection

Arms, Groups and Cohorts

  • Experimental: FCFD4514S
  • Sham Comparator: sham

Clinical Trial Outcome Measures

Primary Measures

  • Growth rate of geographic atrophy (GA) lesion area from baseline
    • Time Frame: Month 18

Secondary Measures

  • Mean change in best corrected visual acuity (BCVA) from baseline
    • Time Frame: Month 18

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 89 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Genentech, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Erich Strauss, M.D., Study Director, Genentech, Inc.

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