Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
NCT ID: NCT05904028
Last Updated: 2026-01-29
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
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RECRUITING
PHASE3
600 participants
INTERVENTIONAL
2023-11-09
2027-07-30
Brief Summary
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Detailed Description
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The main objective of this study is to determine if Home OCT-guided treatment results in 1) better visual acuity outcomes and/or 2) fewer number of injections over 104 weeks compared with treat and extend (T\&E) dosing for nAMD.
Procedures at the baseline visit include eligibility assessment, vision testing, ocular examination, various imaging, and test session on the in-office Home OCT device. Eligible study eyes will enter the run-in phase and receive a baseline intravitreal faricimab injection. If the non-study eye also has nAMD and needs an injection, study faricimab must be used unless the protocol chair has approved of an alternative anti-VEGF. The Notal Vision Monitoring Center must confirm adequate scan quality from the study eye prior to randomization. The Reading Center must also confirm nAMD status based on a preliminary review of baseline images. One Notal Vision confirms the screening Home OCT scans are of good quality and the Reading Center confirms nAMD criteria Is met, the participant can be randomized.
Randomization of eligible study eyes must occur within 14 days of the baseline visit. Prior to randomization, the site must call the participant to confirm they are still willing to participate and agree to follow the daily Home OCT scan requirement if randomized to the Home OCT group. Sites will also confirm the participant's understanding of the trial, willingness to accept the assigned treatment group, and commitment to the follow-up schedule, and compliance with device use.
Eyes receiving an initial faricimab injection that are not eligible for the randomization phase will have a final closeout safety visit 1 month after injection.
Eyes eligible for the randomization phase will be randomly assigned 1:1 into one of two groups to guide follow-up treatment: (1) Treat and Extend or (2) Home OCT-guided treatment. Follow-up for treatment group comparisons of vision and imaging outcomes will occur at 52- and 104-week visits. Additional visits will occur every 4-18 weeks in the T\&E group. Participants assigned to the Home OCT group will self-scan daily using the Home OCT device and will only return for a visit if fluid passing the threshold for an office visit is seen on Home OCT. Follow-up visit procedures include vision testing, ocular exam, and various imaging. The primary outcomes are a comparison of mean change in visual acuity and number of injections from baseline to 104 weeks between the Home OCT vs. T\&E groups (study eye only)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treat and Extend
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Home optical coherence tomography-Guided Treatment
Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule
Intravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule
Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule
Interventions
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Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Intravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule
Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have the capacity to consent on his/her own behalf
* Able to successfully and independently complete at least one self-scanning session on the Home OCT device located at the enrolling clinical site
* Willing to perform once daily Home OCT monitoring tests for 2 years without significant interruption (such as travel of more than 14 days)
* Best corrected E-ETDRS visual acuity ≥24 ETDRS letters (approximately 20/320 or better (Snellen))
* Previously untreated, active MNV lesion (i.e., any intraretinal or subretinal fluid within the center 3 mm diameter circle on OCT) secondary to age-related macular degeneration
* ≥ 1 intermediate drusen (≥ 63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye
Exclusion Criteria
* Prior treatment with intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent or with macular laser for any indication
* Treatment with intravitreal corticosteroids within the last 6 months
* A condition that, in the opinion of the investigator, would preclude participation in the study or ability to complete daily Home OCT scans for 2 years (e.g., unstable medical status that may preclude successful completion of follow-up, dementia, Alzheimer's disease, uncontrollable tremors)
* MNV due to other causes, such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia
50 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Eye Institute (NEI)
NIH
Juvenile Diabetes Research Foundation
OTHER
Jaeb Center for Health Research
OTHER
Responsible Party
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Locations
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Kent W. Small, MD, AMC
Glendale, California, United States
Loma Linda University
Loma Linda, California, United States
East Bay Retina Consultants, Inc.
Oakland, California, United States
Kaiser Permanente - Oakland
Oakland, California, United States
Southern California Desert Retina Consultants, Inc.
Palm Desert, California, United States
UC Davis Health Eye Center
Sacramento, California, United States
Macula Retina Vitreous Institute
Torrance, California, United States
Bay Area Retina Associates A Medical Group
Walnut Creek, California, United States
Retina Consultants
Manchester, Connecticut, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
University of Florida- Jacksonville
Jacksonville, Florida, United States
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida, United States
Argus Research Center, Inc
Naples, Florida, United States
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park, Florida, United States
Retina Associates of Sarasota
Sarasota, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Retina Associates of Florida, LLC
Tampa, Florida, United States
Southeast Retina Center, P.C.
Augusta, Georgia, United States
Thomas Eye Group
Sandy Springs, Georgia, United States
Northwestern Memorial Group
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
UIC - Dept of Ophthalmology & Visual Sciences
Chicago, Illinois, United States
The Trustees of Indiana University
Indianapolis, Indiana, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Wolfe Clinic, P.C.- West Des Moines
West Des Moines, Iowa, United States
Mid-America Retina Consultants, P.A.
Overland Park, Kansas, United States
University of Kentucky Advanced Eye Care
Lexington, Kentucky, United States
Elman Retina Group, BA
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Valley Eye Physicians and Surgeons
Ayer, Massachusetts, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Retina Associates of Michigan
Grand Blanc, Michigan, United States
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States
Associated Retinal Consultants
Traverse City, Michigan, United States
The Retina Institute
St Louis, Missouri, United States
Associated Retinal Surgeons d/b/a Mid Atlantic Retina
Cherry Hill, New Jersey, United States
New York University Langone Health
New York, New York, United States
Macula Care
New York, New York, United States
Vitreous Retina Macula Consultants of NY - VRMNY
New York, New York, United States
Retina Associates of Western NY, P.C.
Rochester, New York, United States
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States
Retina Vitreous Center
Edmond, Oklahoma, United States
Verum Research LLC
Eugene, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Cascade Medical Research Institute, LLC
Springfield, Oregon, United States
Retina Vitreous Consultants
Monroeville, Pennsylvania, United States
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Hilton Head Retina Institute
Hilton Head Island, South Carolina, United States
Ophthalmology Ltd.
Sioux Falls, South Dakota, United States
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, United States
Austin Research Center for Retina
Austin, Texas, United States
Retina Consultants of Texas, PA
Bellaire, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Southwest Retina Consultants
El Paso, Texas, United States
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas, United States
Texas Retina Associates
Lubbock, Texas, United States
Retina Associates of South Texas
San Antonio, Texas, United States
Retinal Consultants of Texas
San Antonio, Texas, United States
The Board of Regents of the University of Wisconsin System
Madison, Wisconsin, United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, United States
Chow Berger Koushan Medicine Professional Corporation o/a Toronto Retina Institute
North YORK, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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Facility Contacts
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Other Identifiers
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Protocol AO
Identifier Type: -
Identifier Source: org_study_id
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