Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD (AO)

July 2, 2026 updated by: Jaeb Center for Health Research
Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Treatment of Neovascular Age-Related Macular Degeneration (nAMD) with anti-vascular endothelial growth factor therapy is highly effective but is associated with considerable treatment burden and cost for patients and the healthcare system. One of the principal barriers to reducing burden and cost is that the optimal number of injections needed to achieve best visual acuity and disease control for any one person is unknown. At present, there are several algorithms that modestly reduce treatment burden, but at the expense of overtreatment in some patients and less optimal disease control in others. The lack of precision in disease management may be due in part to the low frequency of disease monitoring, which typically occurs every one to two months by standard optical coherence tomography (OCT) imaging during an office visit. Home OCT imaging allows daily disease activity monitoring and the possibility of a tailored and more personalized approach to managing neovascular AMD. To understand the role of Home OCT in clinical practice, it is essential to perform a randomized clinical trial that compares visual acuity outcomes, and visit and injection frequencies, obtained using a Home OCT-guided treatment strategy versus outcomes obtained using "Treat and Extend," the treatment algorithm widely perceived to be the most common regimen in clinical practice today.

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)

Study Type

Interventional

Enrollment (Actual)

603

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • North YORK, Ontario, Canada, M3C0G9
        • Chow Berger Koushan Medicine Professional Corporation o/a Toronto Retina Institute
      • Toronto, Ontario, Canada, M5T 2S8
        • University Health Network
  • United States
    • California
      • Glendale, California, United States, 91203-1971
        • Kent W. Small, MD, AMC
      • Loma Linda, California, United States, 92354
        • Loma Linda University
      • Oakland, California, United States, 94611
        • Kaiser Permanente - Oakland
      • Oakland, California, United States, 94609
        • East Bay Retina Consultants, Inc.
      • Palm Desert, California, United States, 92211
        • Southern California Desert Retina Consultants, Inc.
      • Sacramento, California, United States, 95817
        • UC Davis Health Eye Center
      • Torrance, California, United States, 90503
        • Macula Retina Vitreous Institute
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates A Medical Group
    • Connecticut
      • Manchester, Connecticut, United States, 06042
        • Retina Consultants
    • Florida
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute
      • Jacksonville, Florida, United States, 32209
        • University of Florida- Jacksonville
      • Jacksonville, Florida, United States, 32216
        • Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
      • Naples, Florida, United States, 34105
        • Argus Research Center, Inc
      • Pinellas Park, Florida, United States, 33782-4418
        • Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
      • Sarasota, Florida, United States, 34239
        • Sarasota Retina Institute
      • Sarasota, Florida, United States, 34233
        • Retina Associates of Sarasota
      • Tampa, Florida, United States, 33609
        • Retina Associates of Florida, LLC
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center, P.C.
      • Sandy Springs, Georgia, United States, 30328
        • Thomas Eye Group
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60612
        • UIC - Dept of Ophthalmology & Visual Sciences
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Group
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Midwest Eye Institute
      • Indianapolis, Indiana, United States, 46202
        • The Trustees of Indiana University
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Clinic, P.C.- West Des Moines
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Mid-America Retina Consultants, P.A.
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • University of Kentucky Advanced Eye Care
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
      • Baltimore, Maryland, United States, 21237
        • Elman Retina Group, BA
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
        • Valley Eye Physicians and Surgeons
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Grand Blanc, Michigan, United States, 48439
        • Retina Associates of Michigan
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants, P.C.
      • Traverse City, Michigan, United States, 49686
        • Associated Retinal Consultants
    • Missouri
      • St Louis, Missouri, United States, 63128
        • The Retina Institute
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08034
        • Associated Retinal Surgeons d/b/a Mid Atlantic Retina
    • New York
      • New York, New York, United States, 10021
        • Macula Care
      • New York, New York, United States, 10017
        • New York University Langone Health
      • New York, New York, United States, 10022
        • Vitreous Retina Macula Consultants of NY - VRMNY
      • Rochester, New York, United States, 14620
        • Retina Associates of Western NY, P.C.
    • Ohio
      • Cleveland, Ohio, United States, 44120
        • The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Retina Vitreous Center
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Verum Research LLC
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
      • Springfield, Oregon, United States, 97477
        • Cascade Medical Research Institute, LLC
    • Pennsylvania
      • Monroeville, Pennsylvania, United States, 15146
        • Retina Vitreous Consultants
      • Philadelphia, Pennsylvania, United States, 19104
        • The Trustees of the University of Pennsylvania
    • South Carolina
      • Hilton Head Island, South Carolina, United States, 29926
        • Hilton Head Retina Institute
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Ophthalmology Ltd.
    • Tennessee
      • Hixson, Tennessee, United States, 37343
        • Southeastern Retina Associates
      • Knoxville, Tennessee, United States, 37922
        • Southeastern Retina Associates, P.C.
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Research Center for Retina
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas, PA
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • El Paso, Texas, United States, 79902
        • Southwest Retina Consultants
      • Houston, Texas, United States, 77030-4101
        • Baylor College of Medicine, Baylor Eye Physicians and Surgeons
      • Lubbock, Texas, United States, 79424
        • Texas Retina Associates
      • San Antonio, Texas, United States, 78240
        • Retina Associates of South Texas
      • San Antonio, Texas, United States, 78240
        • Retinal Consultants of Texas
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • The Board of Regents of the University of Wisconsin System
      • Wausau, Wisconsin, United States, 54403
        • Eye Clinic of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Age ≥ 50 years
  • 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

Key Exclusion Criteria for Study Eye:

  • Previous treatment for MNV (intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent, or any other AMD therapy)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treat and Extend
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Drug: Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Experimental: Home optical coherence tomography-Guided Treatment
Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule
Device: 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 Names:
  • Home OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
E-ETDRS Change in Visual Acuity Letter Score
Time Frame: Baseline to 104 weeks
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of <20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity.
Baseline to 104 weeks
Number of intravitreal injections of Faricimab (6.0 mg) in the study eye
Time Frame: Baseline to 104 weeks
Baseline to 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaeb Center for Health Research

Collaborators

Juvenile Diabetes Research Foundation
National Eye Institute (NEI)
National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2023

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol AO
  • UG1EY014231 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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