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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

NJ Retina

Toms River, New Jersey, 08755, United States

About this study

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

Patient ID, Date of Birth (DOB), gender, and testing eye From prescribing physician
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.
Structural OCT Images: OCT images (volume scans) acquired following a ForeseeHome alert shall be shared in the registry.
OCT Angiography (OCT-A) Images: OCT-A images acquired following a ForeseeHome alert shall be shared in the registry
Fluorescein Angiography (FA): FA images acquired following a ForeseeHome Alert visit shall be shared in the registry
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.
Status of the eye after exiting the ForeseeHome program regarding conversion to wet-AMD and its timing

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foresee Home

Device

The ForeseeHome Monitoring System, a non-significant risk device, is prescribed by eye care providers to patients as part of their clinical care. Notal Vision Monitoring Center (NVMC) is an independent diagnostic testing facility responsible for clinical monitoring of FSH data. The NVMC communicates with the patients (for training on the use of the device, troubleshooting of device issues, adherence monitoring, etc.) and with the patients' eyecare providers (for reporting FSH alerts, monitoring of clinical outcomes to assess device functionality and ongoing need for the device, etc.).

Primary outcomes

This registry will compare functional and structural data of progression of Intermediate AMD (iAMD) and conversion to neovascular AMD (NV-AMD)

Time frame: 5 years

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.

Sponsors and collaborators

Lead sponsor

Notal Vision Inc.

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2027
First posted: Jan 19, 2023
Registry last updated: Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Active, Not Recruiting