ForeseeHome NRich Registry

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Device: Foresee Home

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

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • NJ Retina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
This registry will compare functional and structural data of progression of Intermediate AMD (iAMD) and conversion to neovascular AMD (NV-AMD)	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 SD-OCT and to validate the predictive value of a non-NV-AMD FSH alerts.	5 years

Collaborators and Investigators

• Sponsor: Notal Vision Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Anticipated): December 15, 2027
• Study Completion (Anticipated): December 15, 2027

Study Registration Dates

• First Submitted: January 10, 2023
• First Submitted That Met QC Criteria: January 10, 2023
• First Posted (Actual): January 19, 2023

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: FSH-R-C2022.001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No