Neovascular Age-related Macular Degeneration
Conditions
Keywords
optical coherence tomography
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)
Interventions
DRUGIntravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
DEVICEIntravitreal 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
Sponsors
Jaeb Center for Health Research
National Institutes of Health (NIH)
National Eye Institute (NEI)
Juvenile Diabetes Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| E-ETDRS Change in Visual Acuity Letter Score | 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. |
| Number of intravitreal injections of Faricimab (6.0 mg) in the study eye | Baseline to 104 weeks | — |
Countries
Canada, United States
Outcome results
None listed