A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
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
2 other identifiers
interventional
143
2 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2011
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2010
CompletedFirst Posted
Study publicly available on registry
October 27, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedNovember 2, 2016
November 1, 2016
2.2 years
October 25, 2010
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Growth rate of geographic atrophy (GA) lesion area from baseline
Month 18
Secondary Outcomes (1)
Mean change in best corrected visual acuity (BCVA) from baseline
Month 18
Study Arms (2)
FCFD4514S
EXPERIMENTALsham
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (36)
Unknown Facility
Tucson, Arizona, 85704, United States
Unknown Facility
Beverly Hills, California, 90211, United States
Unknown Facility
San Francisco, California, 94107, United States
Unknown Facility
Santa Barbara, California, 93103, United States
Unknown Facility
Torrance, California, 90503, United States
Unknown Facility
Boynton Beach, Florida, 33426, United States
Unknown Facility
Fort Lauderdale, Florida, 33334, United States
Unknown Facility
Palm Beach Gardens, Florida, 33410, United States
Unknown Facility
Pensacola, Florida, 32503, United States
Unknown Facility
Winter Haven, Florida, 33880, United States
Unknown Facility
Augusta, Georgia, 30909, United States
Unknown Facility
Paducah, Kentucky, 42001, United States
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Edina, Minnesota, 55435, United States
Unknown Facility
Lynbrook, New York, 11563, United States
Unknown Facility
New York, New York, 10003, United States
Unknown Facility
Rochester, New York, 14642, United States
Unknown Facility
Charlotte, North Carolina, 28210, United States
Unknown Facility
Beachwood, Ohio, 44122, United States
Unknown Facility
Cincinnati, Ohio, 45242, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
West Columbia, South Carolina, 29169, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Abilene, Texas, 79606, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Milwaukee, Wisconsin, 53226, United States
Unknown Facility
Bonn, 53127, Germany
Unknown Facility
Freiburg im Breisgau, 79106, Germany
Unknown Facility
Heidelberg, 69120, Germany
Unknown Facility
Leipzig, 04103, Germany
Unknown Facility
Münster, 48145, Germany
Unknown Facility
Tübingen, 72076, Germany
Related Publications (4)
Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
PMID: 37314061DERIVEDSivaprasad 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.
PMID: 29530781DERIVEDKimel 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.
PMID: 27893095DERIVEDHariri 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.
PMID: 25315664DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Erich Strauss, M.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2010
First Posted
October 27, 2010
Study Start
February 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11