Clinical trial NCT05904028: Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
Official title: Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Keywords: optical coherence tomography
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Eye Institute (NEI)
name: Juvenile Diabetes Research Foundation
First posted: 2023-06-15
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Eligibility criteria: 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

Primary outcomes:
measure: E-ETDRS Change in Visual Acuity Letter Score
timeFrame: Baseline to 104 weeks
measure: Number of intravitreal injections of Faricimab (6.0 mg) in the study eye
timeFrame: Baseline to 104 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Kent W. Small, MD, AMC
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Oakland
country: United States
facility: East Bay Retina Consultants, Inc.
state: California
city: Palm Desert
country: United States
facility: Southern California Desert Retina Consultants, Inc.
state: California
city: Sacramento
country: United States
facility: UC Davis Health Eye Center
state: California
city: Torrance
country: United States
facility: Macula Retina Vitreous Institute
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates A Medical Group
state: California
city: Manchester
country: United States
facility: Retina Consultants
state: Connecticut
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Jacksonville
country: United States
facility: University of Florida- Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
state: Florida
city: Pinellas Park
country: United States
facility: Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
state: Florida
city: Sarasota
country: United States
facility: Retina Associates of Sarasota
state: Florida
city: Tampa
country: United States
facility: Retina Associates of Florida, LLC
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, P.C.
state: Georgia
city: Sandy Springs
country: United States
facility: Thomas Eye Group
state: Georgia
city: Chicago
country: United States
facility: UIC - Dept of Ophthalmology & Visual Sciences
state: Illinois
city: Indianapolis
country: United States
facility: The Trustees of Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Clinic, P.C.- West Des Moines
state: Iowa
city: Overland Park
country: United States
facility: Mid-America Retina Consultants, P.A.
state: Kansas
city: Baltimore
country: United States
facility: Elman Retina Group, BA
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Ayer
country: United States
facility: Valley Eye Physicians and Surgeons
state: Massachusetts
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants, P.C.
state: Michigan
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Cherry Hill
country: United States
facility: Associated Retinal Surgeons d/b/a Mid Atlantic Retina
state: New Jersey
city: Rochester
country: United States
facility: Retina Associates of Western NY, P.C.
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
state: Ohio
city: Edmond
country: United States
facility: Retina Vitreous Center
state: Oklahoma
city: Eugene
country: United States
facility: Verum Research LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Springfield
country: United States
facility: Cascade Medical Research Institute, LLC
state: Oregon
city: Monroeville
country: United States
facility: Retina Vitreous Consultants
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Trustees of the University of Pennsylvania
state: Pennsylvania
city: Hilton Head Island
country: United States
facility: Hilton Head Retina Institute
state: South Carolina
city: Knoxville
country: United States
facility: Southeastern Retina Associates, P.C.
state: Tennessee
city: Bellaire
country: United States
facility: Retina Consultants of Texas, PA
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine, Baylor Eye Physicians and Surgeons
state: Texas
city: Lubbock
country: United States
facility: Texas Retina Associates
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of Texas
state: Texas
city: Madison
country: United States
facility: The Board of Regents of the University of Wisconsin System
state: Wisconsin
city: Wausau
country: United States
facility: Eye Clinic of Wisconsin
state: Wisconsin
city: North York
country: Canada
facility: Chow Berger Koushan Medicine Professional Corporation o/a Toronto Retina Institute
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
References: