A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
NCT ID: NCT02484690
Last Updated: 2020-11-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
273 participants
INTERVENTIONAL
2015-08-11
2017-09-26
Brief Summary
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The study was designed to allow the evaluation of RO6867461 in a treatment-naive population (comparison of Arms A, B, C, and D) and an anti-VEGF-incomplete responder population that met a predefined criterion at Week 12 (comparison between Arms A and E). Only one eye per participant was chosen as the study eye.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
Participants will receive ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) Q4W up to Week 32 (total 9 injections). The final study visit will take place at Week 36.
Ranibizumab
Ranibizumab will be administered as per the regimen specified in the individual arm.
Arm B: Faricimab, 1.5 mg Q4W
Participants will receive faricimab 1.5 mg IVT Q4W up to Week 32 (total 9 injections). The final study visit will take place at Week 36.
Faricimab
Faricimab will be administered as per the regimen specified in the individual arm.
Arm C: Faricimab, 6 mg Q4W
Participants will receive faricimab 6 mg IVT Q4W up to Week 32 (9 injections). The final study visit will take place at Week 36.
Faricimab
Faricimab will be administered as per the regimen specified in the individual arm.
Arm D: Faricimab, 6 mg Every 4-8 weeks
Participants will receive faricimab, 6 mg IVT Q4W up to Week 12 (4 injections), followed by 6 mg IVT every 8 weeks up to Week 28 (2 injections). On Weeks 16, 24, and 32, participants received the sham procedure in order to maintain masking. The final study visit will take place at Week 36.
Faricimab
Faricimab will be administered as per the regimen specified in the individual arm.
Sham Procedure
The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in treatment arm D at applicable visits to maintain masking.
Arm E: Ranibizumab 0.5 mg + Faricimab 6 mg Q4W
Participants will receive ranibizumab, 0.5 mg IVT Q4W up to Week 8 (3 injections), followed by faricimab, 6 mg IVT Q4W up to Week 32 (6 injections). The final study visit will take place at Week 36.
Faricimab
Faricimab will be administered as per the regimen specified in the individual arm.
Ranibizumab
Ranibizumab will be administered as per the regimen specified in the individual arm.
Interventions
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Faricimab
Faricimab will be administered as per the regimen specified in the individual arm.
Ranibizumab
Ranibizumab will be administered as per the regimen specified in the individual arm.
Sham Procedure
The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in treatment arm D at applicable visits to maintain masking.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active CNV
Exclusion Criteria
* Subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than 50% of the total lesion area
* Cataract surgery within 3 months of baseline, or any other previous intraocular surgery
* Major illness or surgery within 1 month prior to Screening
* Glycosylated hemoglobin (HbA1c) above 7.5%
* Uncontrolled blood pressure
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Associated Retina Consultants
Phoenix, Arizona, United States
Retinal Consultants of Arizona
Phoenix, Arizona, United States
California Retina Consultants
Bakersfield, California, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
The Retina Partners
Encino, California, United States
Retina Consultants, San Diego
Poway, California, United States
Orange County Retina Med Group
Santa Ana, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
American Institute of Research
Whittier, California, United States
Retina Consultants of Southern
Colorado Springs, Colorado, United States
Colorado Retina Associates, PC
Golden, Colorado, United States
New England Retina Associates
Hamden, Connecticut, United States
Retina Health Center
Fort Myers, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Central Florida Retina
Orlando, Florida, United States
Retina Care Specialists
Palm Beach Gardens, Florida, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina PC
Marietta, Georgia, United States
Midwest Eye Institute Northside
Indianapolis, Indiana, United States
Paducah Retinal Center
Paducah, Kentucky, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
National Retina Institute
Towson, Maryland, United States
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, United States
Vitreoretinal Surgery
Edina, Minnesota, United States
Retina Associates of NJ
Toms River, New Jersey, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, United States
Long Is. Vitreoretinal Consult
Great Neck, New York, United States
Opthalmic Consultants of LI
Lynbrook, New York, United States
Retina Assoc of Western NY
Rochester, New York, United States
The Retina Consultants
Slingerlands, New York, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Char Eye Ear &Throat Assoc
Charlotte, North Carolina, United States
OSU Eye Physicians & Surgeons
Columbus, Ohio, United States
Oregon Retina, LLP
Eugene, Oregon, United States
Oregon Retina institute
Medford, Oregon, United States
Retina Northwest
Portland, Oregon, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Southeastern Retina Associates Chattanooga
Chattanooga, Tennessee, United States
Charles Retina Institute
Germantown, Tennessee, United States
Tennessee Retina PC.
Nashville, Tennessee, United States
W Texas Retina Consultants PA
Abilene, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Research Center
Austin, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
Retina Associates of Utah
Salt Lake City, Utah, United States
Univ of Virginia Ophthalmology
Charlottesville, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Countries
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References
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Kikuchi Y, Kawczynski MG, Anegondi N, Neubert A, Dai J, Ferrara D, Quezada-Ruiz C. Machine Learning to Predict Faricimab Treatment Outcome in Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2023 Aug 18;4(2):100385. doi: 10.1016/j.xops.2023.100385. eCollection 2024 Mar-Apr.
Yu S, Bachmeier I, Hernandez-Sanchez J, Garcia Armendariz B, Ebneter A, Pauleikhoff D, Chakravarthy U, Fauser S. Hyperreflective Material Boundary Remodeling in Neovascular Age-Related Macular Degeneration: A Post Hoc Analysis of the AVENUE Trial. Ophthalmol Retina. 2023 Nov;7(11):990-998. doi: 10.1016/j.oret.2023.06.024. Epub 2023 Jul 6.
Maunz A, Benmansour F, Li Y, Albrecht T, Zhang YP, Arcadu F, Zheng Y, Madhusudhan S, Sahni J. Accuracy of a Machine-Learning Algorithm for Detecting and Classifying Choroidal Neovascularization on Spectral-Domain Optical Coherence Tomography. J Pers Med. 2021 Jun 8;11(6):524. doi: 10.3390/jpm11060524.
Sahni J, Dugel PU, Patel SS, Chittum ME, Berger B, Del Valle Rubido M, Sadikhov S, Szczesny P, Schwab D, Nogoceke E, Weikert R, Fauser S. Safety and Efficacy of Different Doses and Regimens of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The AVENUE Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):955-963. doi: 10.1001/jamaophthalmol.2020.2685.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BP29647
Identifier Type: -
Identifier Source: org_study_id