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

• Conditions: Geographic Atrophy; MedDRA version: 14.1Level: LLTClassification code 10063947Term: Geographic atrophySystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-019183-36-DE
• Lead Sponsor: GENENTECH, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-18
• Last Update Posted: 26 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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)

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 115

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the ocular and systemic safety and tolerability of FCFD4514S administered ITV monthly or every other month<br>• To investigate evidence of activity with an anatomic outcome of FCFD4514S administered ITV monthly or every other month compared with sham control;Secondary Objective: • To assess best corrected visual acuity (BCVA) on the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at starting distance of 4 meters following ITV FCFD4514S administered monthly or every other month compared with sham control<br>• To characterize systemic immunogenicity of FCFD4514S following multiple ITV doses of FCFD4514S<br>• To characterize the serum pharmacokinetics of FCFD4514S following multiple ITV doses of FCFD4514S;Primary end point(s): Growth rate of geographic atrophy (GA) lesion area from baseline ;Timepoint(s) of evaluation of this end point: Month 18

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Mean change in best corrected visual acuity (BCVA) from baseline;Timepoint(s) of evaluation of this end point: Month 18