Recruiting

AOHome OCT-Guided Treatment vs. Treat and Extend for Neovascular AMD Management

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This phase 3 study aims to compare the effectiveness of home-based treatment using OCT guidance versus the traditional treat and extend approach for managing neovascular age-related macular degeneration, by evaluating changes in visual acuity and the number of intravitreal injections of Faricimab (6.0 mg) in the study eye.

What is being tested

Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule

+ Intravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule

DrugDevice
Who is being recruted

Over 50 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 2023
See protocol details

Summary

Principal SponsorJaeb Center for Health Research
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 9, 2023

Actual date on which the first participant was enrolled.

This study focuses on treating Neovascular Age-Related Macular Degeneration (nAMD), a condition that affects the eyes. Currently, treatment involves anti-vascular endothelial growth factor therapy, which is effective but comes with a high treatment burden and cost. The study aims to find a more personalized approach to manage nAMD, potentially reducing the treatment burden. It uses a home Optical Coherence Tomography (OCT) device for daily disease monitoring, which could lead to better visual acuity outcomes and fewer injections. The study is important as it could improve the quality of life for nAMD patients and reduce healthcare costs. Participants in this study will first undergo eligibility assessment, vision testing, ocular examination, and various imaging. They will also receive an initial injection of faricimab. If eligible, participants will be randomly assigned to one of two groups: the Treat and Extend group or the Home OCT-guided treatment group. The Treat and Extend group will have regular visits every 4-18 weeks, while the Home OCT group will self-scan daily using the Home OCT device and only return for a visit if certain conditions are met. The study's primary outcomes are the comparison of visual acuity and the number of injections between the two groups over a period of 104 weeks.

Official TitleHome OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
NCT05904028
Principal SponsorJaeb Center for Health Research
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 exclusion criteria prevent from participating
Previous treatment for MNV (intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent, or any other AMD therapy)

Prior treatment with intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent or with macular laser for any indication

Treatment with intravitreal corticosteroids within the last 6 months

A condition that, in the opinion of the investigator, would preclude participation in the study or ability to complete daily Home OCT scans for 2 years (e.g., unstable medical status that may preclude successful completion of follow-up, dementia, Alzheimer's disease, uncontrollable tremors)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule

Group II

Experimental
Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 64 locations

Recruiting

Retina Consultants of Texas, PA

Bellaire, United StatesOpen Retina Consultants of Texas, PA in Google Maps
Recruiting

Kent W. Small, MD, AMC

Glendale, United States
Recruiting

Loma Linda University

Loma Linda, United States
Recruiting

East Bay Retina Consultants, Inc.

Oakland, United States
Recruiting
64 Study Centers