Geographic Atrophy MedDRA version: 14.1 Level: LLT Classification code 10063947 Term: Geographic atrophy System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: n.a.
Product Code: FCFD4514S (RO5490249)
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: n.a.
CAS Number: n.a.
Current Sponsor code: FCFD4514S (RO
AFD
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4-
Sponsors
GENENTECH, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the ocular and systemic safety and tolerability of FCFD4514S administered ITV monthly or every other month • 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 • To characterize systemic immunogenicity of FCFD4514S following multiple ITV doses of FCFD4514S • 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean change in best corrected visual acuity (BCVA) from baseline;Timepoint(s) of evaluation of this end point: Month 18 | — |
Countries
Germany, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. C/O F. Hoffmann-La Roche Ltd.
Outcome results
None listed