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

NCT05904028 | Recruiting Phase 3 DMC FDA Drug FDA Device

• 2 other identifiers: Protocol AOUG1EY014231
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 64

Brief Summary

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

Conditions

Neovascular Age-related Macular Degeneration

Keywords

optical coherence tomography

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to 104 weeks

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

  Baseline to 104 weeks

Study Arms (2)

Treat and Extend

EXPERIMENTAL

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

Home optical coherence tomography-Guided Treatment

EXPERIMENTAL

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

Interventions

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

Treat and Extend

Intravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule DEVICE

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

Also known as: Home OCT

Home optical coherence tomography-Guided Treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• National Eye Institute (NEI): collaborator
• Juvenile Diabetes Research Foundation: collaborator
• Jaeb Center for Health Research: lead

Study Sites (64)

Kent W. Small, MD, AMC

Glendale, California, 91203-1971, United States

RECRUITING

Loma Linda University

Loma Linda, California, 92354, United States

RECRUITING

East Bay Retina Consultants, Inc.

Oakland, California, 94609, United States

RECRUITING

Kaiser Permanente - Oakland

Oakland, California, 94611, United States

RECRUITING

Southern California Desert Retina Consultants, Inc.

Palm Desert, California, 92211, United States

RECRUITING

UC Davis Health Eye Center

Sacramento, California, 95817, United States

RECRUITING

Macula Retina Vitreous Institute

Torrance, California, 90503, United States

RECRUITING

Bay Area Retina Associates A Medical Group

Walnut Creek, California, 94598, United States

RECRUITING

Retina Consultants

Manchester, Connecticut, 06042, United States

RECRUITING

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

RECRUITING

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

RECRUITING

University of Florida- Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

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

Jacksonville, Florida, 32216, United States

RECRUITING

Argus Research Center, Inc

Naples, Florida, 34105, United States

RECRUITING

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

Pinellas Park, Florida, 33782-4418, United States

RECRUITING

Retina Associates of Sarasota

Sarasota, Florida, 34233, United States

RECRUITING

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

RECRUITING

Retina Associates of Florida, LLC

Tampa, Florida, 33609, United States

RECRUITING

Southeast Retina Center, P.C.

Augusta, Georgia, 30909, United States

RECRUITING

Thomas Eye Group

Sandy Springs, Georgia, 30328, United States

RECRUITING

Northwestern Memorial Group

Chicago, Illinois, 60611, United States

RECRUITING

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

UIC - Dept of Ophthalmology & Visual Sciences

Chicago, Illinois, 60612, United States

RECRUITING

The Trustees of Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

RECRUITING

Wolfe Clinic, P.C.- West Des Moines

West Des Moines, Iowa, 50266, United States

RECRUITING

Mid-America Retina Consultants, P.A.

Overland Park, Kansas, 66211, United States

RECRUITING

University of Kentucky Advanced Eye Care

Lexington, Kentucky, 40508, United States

RECRUITING

Elman Retina Group, BA

Baltimore, Maryland, 21237, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Valley Eye Physicians and Surgeons

Ayer, Massachusetts, 01432, United States

RECRUITING

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Retina Associates of Michigan

Grand Blanc, Michigan, 48439, United States

RECRUITING

Associated Retinal Consultants, P.C.

Royal Oak, Michigan, 48073, United States

RECRUITING

Associated Retinal Consultants

Traverse City, Michigan, 49686, United States

RECRUITING

The Retina Institute

St Louis, Missouri, 63128, United States

RECRUITING

Associated Retinal Surgeons d/b/a Mid Atlantic Retina

Cherry Hill, New Jersey, 08034, United States

RECRUITING

New York University Langone Health

New York, New York, 10017, United States

RECRUITING

Macula Care

New York, New York, 10021, United States

RECRUITING

Vitreous Retina Macula Consultants of NY - VRMNY

New York, New York, 10022, United States

RECRUITING

Retina Associates of Western NY, P.C.

Rochester, New York, 14620, United States

RECRUITING

The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine

Cleveland, Ohio, 44120, United States

RECRUITING

Retina Vitreous Center

Edmond, Oklahoma, 73013, United States

RECRUITING

Verum Research LLC

Eugene, Oregon, 97401, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Cascade Medical Research Institute, LLC

Springfield, Oregon, 97477, United States

RECRUITING

Retina Vitreous Consultants

Monroeville, Pennsylvania, 15146, United States

RECRUITING

The Trustees of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Hilton Head Retina Institute

Hilton Head Island, South Carolina, 29926, United States

RECRUITING

Ophthalmology Ltd.

Sioux Falls, South Dakota, 57108, United States

RECRUITING

Southeastern Retina Associates, P.C.

Knoxville, Tennessee, 37922, United States

RECRUITING

Austin Research Center for Retina

Austin, Texas, 78705, United States

RECRUITING

Retina Consultants of Texas, PA

Bellaire, Texas, 77401, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Southwest Retina Consultants

El Paso, Texas, 79902, United States

RECRUITING

Baylor College of Medicine, Baylor Eye Physicians and Surgeons

Houston, Texas, 77030-4101, United States

RECRUITING

Texas Retina Associates

Lubbock, Texas, 79424, United States

RECRUITING

Retina Associates of South Texas

San Antonio, Texas, 78240, United States

RECRUITING

Retinal Consultants of Texas

San Antonio, Texas, 78240, United States

RECRUITING

The Board of Regents of the University of Wisconsin System

Madison, Wisconsin, 53705, United States

RECRUITING

Eye Clinic of Wisconsin

Wausau, Wisconsin, 54403, United States

RECRUITING

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

North YORK, Ontario, M3C0G9, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Visual acuity and imaging technicians will be masked to the participant's treatment group assignment, as will the central Reading Centers. Investigators, coordinators, and participants will be unmasked to treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: November 9, 2023
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-05

Locations

CA (2); US (62)