The Efficacy of Home OCT Supported Management in Patients Diagnosed With Neovascular-AMD and Undergoing a Drug Switch to Faricimab

NCT07744984 | Completed

• 1 other identifier: 0337-24-RMC
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration (AMD); Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD

Keywords

Neovascular AMD; Wet AMD; Home OCT; Optical Coherence Tomography; Faricimab; Anti-VEGF; Retina; Home Monitoring; Notal Vision

Outcome Measures

Primary Outcomes (1)

• Measure the efficacy of Home-OCT in the management of nvAMD treated with Faricimab.

  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.

  Up to 12 months

Secondary Outcomes (2)

• Faricimab Injection Interval

  Up to 12 months

• Number of Faricimab Injections

  Up to 12 months

Study Arms (1)

Home OCT Monitoring Cohort

Participants with neovascular age-related macular degeneration (nAMD) who are switching to faricimab after an inadequate response to previous anti-VEGF therapy. Participants will receive standard clinical care and perform home retinal monitoring using the Notal Vision Home OCT device at least four times per week for up to 12 months. Home OCT images will be reviewed by the study investigators to support disease monitoring and clinical decision-making.

Device: Home Optical Coherence Tomography (Home OCT)

Interventions

Home Optical Coherence Tomography (Home OCT) DEVICE

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

Also known as: Notal Vision Home OCT, SCANLY Home OCT

Home OCT Monitoring Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include up to 20 patients diagnosed with nvAMD who received at least 3 consecutive anti VEGF injections without showing a treatment response, as confirmed by a retina specialist, and who are being transitioned to treatment with Faricimab per the discretion of their treating retina specialist. All patients in the study will sign a consent form.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel, 4941492, Israel

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Imaging Unit, Retina Specialist, Principle Investigator

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 4, 2026
• Study Start: July 3, 2024
• Primary Completion: April 1, 2026
• Study Completion: July 1, 2026
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)