Clinical trial NCT05690880: ForeseeHome NRich Registry
Official title: ForeseeHome NRich Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Age-Related Macular Degeneration
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-19
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants include those actively monitoring on the FSH program which requires diagnosis of intermediate AMD and visual acuity of 20/60 or better that establish a valid baseline in at least one eye. The process of establishing a baseline is completed several weeks after setup of the device at home and initiation of testing. The aim of the registry is to collect data up to 20,000 patients on the ForeseeHome program for at least one year. The data will be collected for approximately a period of 5 years.The registry will include clinics that provide direct care to the patients on the ForeseeHome device, and Notal Vision Monitoring Center. The registry aims to collect data from about 200 referring physicians.

Brief summary: This registry will compare functional and structural data of progression of Intermediate AMD (iAMD) and conversion to neovascular AMD (NV-AMD) while monitored at home with the ForeseeHome Monitoring System (FSH) and during routine care with Spectral Domain Optical Coherence Tomography (SD-OCT) and to validate the predictive value of a non-NV-AMD FSH alerts.

Detailed description: The participants include those actively monitoring on the FSH program which requires diagnosis of intermediate AMD and visual acuity of 20/60 or better that establish a valid baseline in at least one eye. The process of establishing a baseline is completed several weeks after setup of the device at home and initiation of testing. The aim of the registry is to collect data up to 20,000 patients on the ForeseeHome program for at least one year. The data will be collected for approximately a period of 5 years.

The registry will include clinics that provide direct care to the patients on the ForeseeHome device, and Notal Vision Monitoring Center. The registry aims to collect data from about 200 referring physicians.

The registry will include structural and functional data for the patients active on the ForeseeHome device. The details of data points to be collected are mentioned below.

Data from participating sites will be collected in a de-identified manner and collected in the registry. Patients will be assigned a patient ID and will be collected in a sequential manner from each site. No data shall be acquired outside standard of care. Not all data points for each patient are expected to be present. The following data points shall be shared in the registry:

From Notal Vision Monitoring Center

1. Patient ID, Date of Birth (DOB), gender, and testing eye From prescribing physician
2. Visual Acuity: Visual acuity as measured during regular examination, in a period when the patient is active on the ForeseeHome program, shall be shared in the registry. Maximum 2 visual acuity measurements shall be shared during one calendar year.
3. Structural OCT Images: OCT images (volume scans) acquired following a ForeseeHome alert shall be shared in the registry.
4. OCT Angiography (OCT-A) Images: OCT-A images acquired following a ForeseeHome alert shall be shared in the registry
5. Fluorescein Angiography (FA): FA images acquired following a ForeseeHome Alert visit shall be shared in the registry
6. Diagnosis of wet-AMD in case of ForeseeHome alert: The diagnosis related to status of patient's macular degeneration in both eyes shall be shared in the registry in case of an alert.
7. Status of the eye after exiting the ForeseeHome program regarding conversion to wet-AMD and its timing

Eligibility criteria: Inclusion Criteria:

* The participants include those actively monitoring on the FSH program which requires diagnosis of intermediate AMD and visual acuity of 20/60 or better that establish a valid baseline in at least one eye.

Exclusion Criteria:

* Patients that are unable to establish a baseline

Primary outcomes:
measure: This registry will compare functional and structural data of progression of Intermediate AMD (iAMD) and conversion to neovascular AMD (NV-AMD)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toms River
country: United States
facility: NJ Retina
state: New Jersey
Study officials:
References: