Back to resultsA Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
Primary Purpose
Geographic Atrophy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FCFD4514S
sham
Sponsored by
About this trial
This is an interventional treatment trial for Geographic Atrophy
Eligibility 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)
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
FCFD4514S
sham
Arm Description
Outcomes
Primary Outcome Measures
Growth rate of geographic atrophy (GA) lesion area from baseline
Secondary Outcome Measures
Mean change in best corrected visual acuity (BCVA) from baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01229215
Brief Title
A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FCFD4514S
Arm Type
Experimental
Arm Title
sham
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
FCFD4514S
Intervention Description
Repeating intravitreal injection
Intervention Type
Drug
Intervention Name(s)
sham
Intervention Description
Repeating sham injection
Primary Outcome Measure Information:
Title
Growth rate of geographic atrophy (GA) lesion area from baseline
Time Frame
Month 18
Secondary Outcome Measure Information:
Title
Mean change in best corrected visual acuity (BCVA) from baseline
Time Frame
Month 18
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erich Strauss, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
City
Lynbrook
State/Province
New York
ZIP/Postal Code
11563
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
City
Bonn
ZIP/Postal Code
53127
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
City
Munster
ZIP/Postal Code
48145
Country
Germany
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29530781
Citation
Sivaprasad S, Tschosik E, Kapre A, Varma R, Bressler NM, Kimel M, Dolan C, Silverman D. Reliability and Construct Validity of the NEI VFQ-25 in a Subset of Patients With Geographic Atrophy From the Phase 2 Mahalo Study. Am J Ophthalmol. 2018 Jun;190:1-8. doi: 10.1016/j.ajo.2018.03.006. Epub 2018 Mar 10.
Results Reference
derived
PubMed Identifier
27893095
Citation
Kimel M, Leidy NK, Tschosik E, Dolan C, Souied EH, Varma R, Bressler NM. Functional Reading Independence (FRI) Index: A New Patient-Reported Outcome Measure for Patients With Geographic Atrophy. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6298-6304. doi: 10.1167/iovs.16-20361. Erratum In: Invest Ophthalmol Vis Sci. 2017 Jul 1;58(9):3825.
Results Reference
derived
PubMed Identifier
25315664
Citation
Hariri A, Nittala MG, Sadda SR. Outer retinal tubulation as a predictor of the enlargement amount of geographic atrophy in age-related macular degeneration. Ophthalmology. 2015 Feb;122(2):407-13. doi: 10.1016/j.ophtha.2014.08.035. Epub 2014 Oct 12.
Results Reference
derived
Learn more about this trial
A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
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