Actively Recruiting
Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular Age-Related Macular Degeneration
Led by Jaeb Center for Health Research · Updated on 2026-05-18
600
Participants Needed
65
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two approaches for managing neovascular age-related macular degeneration (nAMD) to find out if home optical coherence tomography (OCT)-guided treatment improves visual outcomes or reduces the number of injections compared to the common Treat and Extend dosing method. The study addresses the current challenge of determining the optimal number of anti-vascular endothelial growth factor (anti-VEGF) injections needed for each patient, aiming to reduce treatment burden and costs by allowing more personalized care through daily monitoring with home OCT. Participants will receive intravitreal injections of 6 mg faricimab and be randomly assigned to either the Treat and Extend group or the Home OCT-guided treatment group. The Treat and Extend group will have office visits every 4 to 18 weeks for vision testing and imaging, while the Home OCT group will perform daily self-scans at home and only return for visits when disease activity is detected by the home device. The study includes a baseline phase with initial injection and imaging confirmation before randomization, followed by 104 weeks of treatment and monitoring. During the study, participants will undergo vision tests, eye exams, and various imaging procedures at scheduled visits or as triggered by home OCT scans. Researchers will track changes in visual acuity and count the number of injections over two years. Close monitoring ensures scan quality and disease status before randomization. The study measures include the change in visual acuity letter score and total injections received, aiming to compare the effectiveness and treatment burden between the two methods over 104 weeks.
CONDITIONS
Brief Title
Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Ability to provide informed consent independently
- Ability to successfully complete at least one self-scanning session on the Home OCT device at the study site
- Willingness to perform daily Home OCT monitoring tests for 2 years without significant interruption
- Best corrected visual acuity of 24 ETDRS letters (approximately 20/320 Snellen) or better
- Presence of previously untreated, active macular neovascularization lesion with intraretinal or subretinal fluid in the center 3 mm diameter on OCT
- At least one intermediate drusen (63 microns or larger) in either eye or late age-related macular degeneration in the other eye
You will not qualify if you...
- Previous treatment for macular neovascularization including any intravitreal anti-VEGF or anti-Ang2 injections or other AMD therapies
- Prior treatment with macular laser for any reason
- Treatment with intravitreal corticosteroids within the last 6 months
- Medical or neurological conditions that prevent participation or daily Home OCT scans for 2 years (e.g., unstable health, dementia, Alzheimer's disease, uncontrollable tremors)
- Macular neovascularization caused by conditions other than age-related macular degeneration such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment, vision testing, ocular examination, imaging, and test session on the in-office Home OCT device
Duration - Up to 14 days
Participants receive a baseline intravitreal faricimab injection and undergo confirmation of scan quality and disease status before randomization.
1 visit (in-person) for baseline injection and assessments; additional call to confirm continued participation before randomization
Duration - 104 weeks
Participants receive intravitreal injections of faricimab guided by either a Treat and Extend schedule or a Home OCT-guided treatment schedule.
In the Treat and Extend group: visits every 4 to 18 weeks; in the Home OCT group: visits only when device detects fluid exceeding threshold
Duration - Scheduled within 104 weeks
Participants have vision testing, ocular exams, and imaging at 52- and 104-week visits to assess outcomes.
2 visits (in-person) at weeks 52 and 104
Trial Site Locations
Total: 65 locations
1
Kent W. Small, MD, AMC
Glendale, California, United States, 91203-1971
Actively Recruiting
2
Loma Linda University
Loma Linda, California, United States, 92354
Actively Recruiting
3
East Bay Retina Consultants, Inc.
Oakland, California, United States, 94609
Actively Recruiting
4
Kaiser Permanente - Oakland
Oakland, California, United States, 94611
Actively Recruiting
5
Southern California Desert Retina Consultants, Inc.
Palm Desert, California, United States, 92211
Actively Recruiting
6
UC Davis Health Eye Center
Sacramento, California, United States, 95817
Actively Recruiting
7
Macula Retina Vitreous Institute
Torrance, California, United States, 90503
Actively Recruiting
8
Bay Area Retina Associates A Medical Group
Walnut Creek, California, United States, 94598
Actively Recruiting
9
Retina Consultants
Manchester, Connecticut, United States, 06042
Actively Recruiting
10
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Actively Recruiting
11
National Ophthalmic Research Institute
Fort Myers, Florida, United States, 33912
Actively Recruiting
12
University of Florida- Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
13
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida, United States, 32216
Actively Recruiting
14
Argus Research Center, Inc
Naples, Florida, United States, 34105
Actively Recruiting
15
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park, Florida, United States, 33782-4418
Actively Recruiting
16
Retina Associates of Sarasota
Sarasota, Florida, United States, 34233
Actively Recruiting
17
Sarasota Retina Institute
Sarasota, Florida, United States, 34239
Actively Recruiting
18
Retina Associates of Florida, LLC
Tampa, Florida, United States, 33609
Actively Recruiting
19
Southeast Retina Center, P.C.
Augusta, Georgia, United States, 30909
Actively Recruiting
20
Thomas Eye Group
Sandy Springs, Georgia, United States, 30328
Actively Recruiting
21
Northwestern Memorial Group
Chicago, Illinois, United States, 60611
Actively Recruiting
22
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
23
UIC - Dept of Ophthalmology & Visual Sciences
Chicago, Illinois, United States, 60612
Actively Recruiting
24
The Trustees of Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
25
Midwest Eye Institute
Indianapolis, Indiana, United States, 46290
Actively Recruiting
26
Wolfe Clinic, P.C.- West Des Moines
West Des Moines, Iowa, United States, 50266
Actively Recruiting
27
Mid-America Retina Consultants, P.A.
Overland Park, Kansas, United States, 66211
Actively Recruiting
28
University of Kentucky Advanced Eye Care
Lexington, Kentucky, United States, 40508
Actively Recruiting
29
Elman Retina Group, BA
Baltimore, Maryland, United States, 21237
Actively Recruiting
30
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
31
Valley Eye Physicians and Surgeons
Ayer, Massachusetts, United States, 01432
Actively Recruiting
32
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
33
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
34
Retina Associates of Michigan
Grand Blanc, Michigan, United States, 48439
Actively Recruiting
35
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States, 48073
Actively Recruiting
36
Associated Retinal Consultants
Traverse City, Michigan, United States, 49686
Actively Recruiting
37
The Retina Institute
St Louis, Missouri, United States, 63128
Actively Recruiting
38
Associated Retinal Surgeons d/b/a Mid Atlantic Retina
Cherry Hill, New Jersey, United States, 08034
Actively Recruiting
39
New York University Langone Health
New York, New York, United States, 10017
Actively Recruiting
40
Macula Care
New York, New York, United States, 10021
Actively Recruiting
41
Vitreous Retina Macula Consultants of NY - VRMNY
New York, New York, United States, 10022
Actively Recruiting
42
Retina Associates of Western NY, P.C.
Rochester, New York, United States, 14620
Actively Recruiting
43
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States, 44120
Actively Recruiting
44
Retina Vitreous Center
Edmond, Oklahoma, United States, 73013
Actively Recruiting
45
Verum Research LLC
Eugene, Oregon, United States, 97401
Actively Recruiting
46
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
47
Cascade Medical Research Institute, LLC
Springfield, Oregon, United States, 97477
Actively Recruiting
48
Retina Vitreous Consultants
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
49
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
50
Hilton Head Retina Institute
Hilton Head Island, South Carolina, United States, 29926
Actively Recruiting
51
Ophthalmology Ltd.
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
52
Southeastern Retina Associates
Hixson, Tennessee, United States, 37343
Actively Recruiting
53
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, United States, 37922
Actively Recruiting
54
Austin Research Center for Retina
Austin, Texas, United States, 78705
Actively Recruiting
55
Retina Consultants of Texas, PA
Bellaire, Texas, United States, 77401
Actively Recruiting
56
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
57
Southwest Retina Consultants
El Paso, Texas, United States, 79902
Actively Recruiting
58
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas, United States, 77030-4101
Actively Recruiting
59
Texas Retina Associates
Lubbock, Texas, United States, 79424
Actively Recruiting
60
Retina Associates of South Texas
San Antonio, Texas, United States, 78240
Actively Recruiting
61
Retinal Consultants of Texas
San Antonio, Texas, United States, 78240
Actively Recruiting
62
The Board of Regents of the University of Wisconsin System
Madison, Wisconsin, United States, 53705
Actively Recruiting
63
Eye Clinic of Wisconsin
Wausau, Wisconsin, United States, 54403
Actively Recruiting
64
Chow Berger Koushan Medicine Professional Corporation o/a Toronto Retina Institute
North YORK, Ontario, Canada, M3C0G9
Actively Recruiting
65
University Health Network
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here