A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy
NCT ID: NCT01229215
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2011-02-28
2013-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FCFD4514S
FCFD4514S
Repeating intravitreal injection
sham
sham
Repeating sham injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FCFD4514S
Repeating intravitreal injection
sham
Repeating sham injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)
Exclusion Criteria
* 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
60 Years
89 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Erich Strauss, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tucson, Arizona, United States
Beverly Hills, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Torrance, California, United States
Boynton Beach, Florida, United States
Fort Lauderdale, Florida, United States
Palm Beach Gardens, Florida, United States
Pensacola, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
Paducah, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Edina, Minnesota, United States
Lynbrook, New York, United States
New York, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
West Columbia, South Carolina, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Dallas, Texas, United States
Milwaukee, Wisconsin, United States
Bonn, , Germany
Freiburg im Breisgau, , Germany
Heidelberg, , Germany
Leipzig, , Germany
Münster, , Germany
Tübingen, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GX01456
Identifier Type: OTHER
Identifier Source: secondary_id
CFD4870g
Identifier Type: -
Identifier Source: org_study_id