Age-Related Macular Degeneration (AMD), Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD
Conditions
Keywords
Neovascular AMD, Wet AMD, Home OCT, Optical Coherence Tomography, Faricimab, Anti-VEGF, Retina, Home Monitoring, Notal Vision
Brief summary
Age-related macular degeneration (AMD) is a common eye disease that can lead to vision loss. The neovascular ("wet") form of AMD is usually treated with repeated injections into the eye. However, some patients do not respond well to their current treatment and need to switch to a different medication. The purpose of this study is to evaluate whether using a home optical coherence tomography (Home OCT) device can improve the management of patients with neovascular AMD who are switching to faricimab treatment after an insufficient response to previous therapy. The Home OCT device allows participants to perform retinal scans at home several times a week. These scans are securely transmitted to the study team, allowing physicians to monitor changes in the retina more frequently than with routine clinic visits alone. Participants will continue to receive the standard medical care determined by their treating retina specialist, including clinic visits, eye examinations, retinal imaging, and intravitreal injections. The Home OCT device will provide additional information to help detect changes in disease activity between clinic visits. If the scans suggest worsening of the condition, participants may be asked to return for an earlier evaluation. The study aims to determine whether frequent home monitoring can identify treatment response sooner and support more personalized treatment decisions. The study will also collect information on the effectiveness of faricimab in routine clinical practice after switching from previous anti-VEGF therapy.
Interventions
DEVICEHome Optical Coherence Tomography (Home OCT)
Participants will be provided with a Notal Vision Home OCT device for home retinal imaging. They will perform self-imaging at least four times per week throughout the study. OCT images will be securely transmitted to the study team for remote review, enabling frequent monitoring of retinal fluid and disease activity in addition to routine clinical care
Sponsors
Rabin Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at least 55 years of age. * Visual Acuity of 20/320 or better in the study eye. * Diagnosis of active nvAMD that was treated with at least 3 consecutive anti-VEGF injections. * Patients are meeting the standard care criteria to switch to a second line drug. * Patients are able and willing to conduct daily OCT self-imaging at home for the duration of the study. * Patient signing a consent form
Exclusion criteria
* Patients with any other retinal disease in the study eye requiring steroidal or anti-VEGF injections (anti-VEGF injections during the study period must be for nvAMD). * Any concurrent ocular condition precluding acquisition of OCT images (eg, severe blepharoptosis, corneal opacification, cataract etc) in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the efficacy of Home-OCT in the management of nvAMD treated with Faricimab. | Up to 12 months | Time from the first faricimab injection to successful treatment response, defined by the investigator based on the ability to maintain disease control while extending treatment intervals, as assessed using Home OCT monitoring, clinical examination, and retinal imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Faricimab Injection Interval | Up to 12 months | Mean interval between consecutive faricimab injections during the study |
| Number of Faricimab Injections | Up to 12 months | Total number of faricimab injections administered during the study period. |
Countries
Israel
Outcome results
None listed