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Neovascular Age-related Macular DegenerationPhase 3AONCT05904028

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

A Phase 3 study testing Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule and Intravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule in people with Neovascular Age-related Macular Degeneration, run by Jaeb Center for Health Research at 64 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule and Intravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule
Could I receive a placebo?
No, everyone receives an active treatment
How many people
603 participants
Where
64 sitesin 2 countries
Study dates
9 Nov 2023to 30 Jul 2027
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

64 sites in 2 countries.

64 sites in 2 countries

United States62 sites

  • Southeast Retina Center, P.C.

    Augusta, Georgia, 30909

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • Valley Eye Physicians and Surgeons

    Ayer, Massachusetts, 01432

  • Elman Retina Group, BA

    Baltimore, Maryland, 21237

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Retina Consultants of Texas, PA

    Bellaire, Texas, 77401

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Associated Retinal Surgeons d/b/a Mid Atlantic Retina

    Cherry Hill, New Jersey, 08034

  • Northwestern Memorial Group

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • UIC - Dept of Ophthalmology & Visual Sciences

    Chicago, Illinois, 60612

  • The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine

    Cleveland, Ohio, 44120

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Retina Vitreous Center

    Edmond, Oklahoma, 73013

  • Southwest Retina Consultants

    El Paso, Texas, 79902

  • Verum Research LLC

    Eugene, Oregon, 97401

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Kent W. Small, MD, AMC

    Glendale, California, 91203-1971

  • Retina Associates of Michigan

    Grand Blanc, Michigan, 48439

  • Hilton Head Retina Institute

    Hilton Head Island, South Carolina, 29926

  • Southeastern Retina Associates

    Hixson, Tennessee, 37343

  • Baylor College of Medicine, Baylor Eye Physicians and Surgeons

    Houston, Texas, 77030-4101

  • The Trustees of Indiana University

    Indianapolis, Indiana, 46202

  • Midwest Eye Institute

    Indianapolis, Indiana, 46290

  • University of Florida- Jacksonville

    Jacksonville, Florida, 32209

  • Florida Retina Institute, James A. Staman, MD, PA- Jacksonville

    Jacksonville, Florida, 32216

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee, 37922

  • University of Kentucky Advanced Eye Care

    Lexington, Kentucky, 40508

  • Loma Linda University

    Loma Linda, California, 92354

  • Texas Retina Associates

    Lubbock, Texas, 79424

  • The Board of Regents of the University of Wisconsin System

    Madison, Wisconsin, 53705

  • Retina Consultants

    Manchester, Connecticut, 06042

  • Retina Vitreous Consultants

    Monroeville, Pennsylvania, 15146

  • Argus Research Center, Inc

    Naples, Florida, 34105

  • New York University Langone Health

    New York, New York, 10017

  • Macula Care

    New York, New York, 10021

  • Vitreous Retina Macula Consultants of NY - VRMNY

    New York, New York, 10022

  • East Bay Retina Consultants, Inc.

    Oakland, California, 94609

  • Kaiser Permanente - Oakland

    Oakland, California, 94611

  • Mid-America Retina Consultants, P.A.

    Overland Park, Kansas, 66211

  • Southern California Desert Retina Consultants, Inc.

    Palm Desert, California, 92211

  • The Trustees of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Southeast Eye Institute, P.A. dba Eye Associates of Pinellas

    Pinellas Park, Florida, 33782-4418

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Retina Associates of Western NY, P.C.

    Rochester, New York, 14620

  • Associated Retinal Consultants, P.C.

    Royal Oak, Michigan, 48073

  • UC Davis Health Eye Center

    Sacramento, California, 95817

  • Retina Associates of South Texas

    San Antonio, Texas, 78240

  • Retinal Consultants of Texas

    San Antonio, Texas, 78240

  • Thomas Eye Group

    Sandy Springs, Georgia, 30328

  • Retina Associates of Sarasota

    Sarasota, Florida, 34233

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Ophthalmology Ltd.

    Sioux Falls, South Dakota, 57108

  • Cascade Medical Research Institute, LLC

    Springfield, Oregon, 97477

  • The Retina Institute

    St Louis, Missouri, 63128

  • Retina Associates of Florida, LLC

    Tampa, Florida, 33609

  • Macula Retina Vitreous Institute

    Torrance, California, 90503

  • Associated Retinal Consultants

    Traverse City, Michigan, 49686

  • Bay Area Retina Associates A Medical Group

    Walnut Creek, California, 94598

  • Eye Clinic of Wisconsin

    Wausau, Wisconsin, 54403

  • Wolfe Clinic, P.C.- West Des Moines

    West Des Moines, Iowa, 50266

Other trials in United States

Canada2 sites

  • Chow Berger Koushan Medicine Professional Corporation o/a Toronto Retina Institute

    North YORK, Ontario, M3C0G9

  • University Health Network

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.

Read the 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)

Being tested
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
Keywords
optical coherence tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravitreal injections of 6 mg faricimab on a Treat and Extend scheduleDrug

    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 scheduleDevice

    Also called Home OCT

    Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule

Study groups in NCT05904028
Study groupRoleWhat they receive
Treat and ExtendExperimentalIntravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Receives: Drug: Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Home optical coherence tomography-Guided TreatmentExperimentalIntravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule
Receives: Device: Intravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. E-ETDRS Change in Visual Acuity Letter Score

    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.

    Measured: Baseline to 104 weeks

  2. Number of intravitreal injections of Faricimab (6.0 mg) in the study eye

    Measured: Baseline to 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start9 Nov 2023
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
603 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05904028
Sponsor's protocol ID
Protocol AO
Other IDs
UG1EY014231
Acronym
AO
Status last verified
Jul 2026
First submitted
6 Jun 2023
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes

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