Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05904028 |
| Other study ID # |
Protocol AO |
| Secondary ID |
UG1EY014231 |
| Status |
Recruiting |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
November 9, 2023 |
| Est. completion date |
July 30, 2027 |
Study information
| Verified date |
June 2024 |
| Source |
Jaeb Center for Health Research |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Home optical coherence tomography- guided treatment versus treat and extend for the
management of neovascular age-related macular degeneration.
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.
Upon completion of baseline testing procedures, eligible study eyes will enter the run-in
phase and be given an injection of faricimab. The participant will be provided with a
post-injection instruction sheet and will be reminded that the site will follow-up regarding
eligibility for the randomization phase. The Notal Vision Monitoring Center must confirm
adequate scan quality from the study eye prior to randomization. Once Notal Vision Monitoring
Center confirms acceptable scans, randomization can be completed. The participant does not
need to be present in the office for randomization. Randomization of eligible study eyes must
occur within 10 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.
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. Participants must meet criteria for successful scanning as confirmed by Notal
Vision for eligibility into the randomization phase. 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.
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. For eyes in the
randomization phase, 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).
