AOHome OCT-Guided Treatment vs. Treat and Extend for Neovascular AMD Management
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.
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
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.600 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy 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
Retina Consultants of Texas, PA
Bellaire, United StatesOpen Retina Consultants of Texas, PA in Google MapsKent W. Small, MD, AMC
Glendale, United StatesLoma Linda University
Loma Linda, United StatesEast Bay Retina Consultants, Inc.
Oakland, United States