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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Key Who May Qualify: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

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

Locations (20)

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