Age-Related Macular Degeneration (AMD)NCT07744984
The Efficacy of Home OCT Supported Management in Patients Diagnosed With Neovascular-AMD and Undergoing a Drug Switch to Faricimab
An observational study of Age-Related Macular Degeneration (AMD) and Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-Related Macular Degeneration (AMD), Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD
- What is being tested?
- Home Optical Coherence Tomography (Home OCT)
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Jul 2024to 1 Jul 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home OCT-Guided Management of Neovascular Age Related Macular Degeneration: Outcomes and Insight After Switch to Faricimab for One Year
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.
Read more
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
- Being tested
- Home Optical Coherence Tomography (Home OCT)
- Keywords
- Neovascular AMD, Wet AMD, Home OCT, Optical Coherence Tomography, Faricimab, Anti-VEGF, Retina, Home Monitoring, Notal Vision
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Optical Coherence Tomography (Home OCT)Device
Also called Notal Vision Home OCT, SCANLY 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Home Optical Coherence Tomography (Home OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (2)
Faricimab Injection Interval
Mean interval between consecutive faricimab injections during the study
Measured: Up to 12 months
Number of Faricimab Injections
Total number of faricimab injections administered during the study period.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start3 Jul 2024
- Primary completion1 Apr 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orly Gal-Or, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744984
- Sponsor's protocol ID
- 0337-24-RMC
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No