Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904028
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2023-06-06
Brief Title:
Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AO
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 andor 2 fewer number of injections over 104 weeks compared with treat and extend TE dosing for nAMD
Upon completion of baseline testing procedures eligible study eyes will enter the run-in phase and be given an injection of study faricimab 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 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 participants 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 11 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 TE 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 TE groups study eye only
The main objective of this study is to determine if Home OCT-guided treatment results in 1 better visual acuity outcomes andor 2 fewer number of injections over 104 weeks compared with treat and extend TE dosing for nAMD
Upon completion of baseline testing procedures eligible study eyes will enter the run-in phase and be given an injection of study faricimab 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 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 participants 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 11 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 TE 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 TE groups study eye only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UG1EY014231 | NIH | None | httpsreporternihgovquickSearchUG1EY014231 |