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

Geographic Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229215
• Other study ID #: CFD4870g
• Secondary ID: GX01456
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2010
• Last updated: November 1, 2016
• Start date: February 2011
• Est. completion date: April 2013

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 89 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth rate of geographic atrophy (GA) lesion area from baseline		Month 18	No
Secondary	Mean change in best corrected visual acuity (BCVA) from baseline		Month 18	No