RecruitingPhase 4NCT05093374

Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting

Personalized Treatment Aided by Automated Analysis of Fluid in Active Neovascular Age-related Macular Degeneration (nAMD) in a Prospective, Multicenter, Randomized Study.


Sponsor

Medical University of Vienna

Enrollment

290 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to implement quantitative assessment tools for the treatment of active neovascular AMD patients in a real-world setting in order to provide advantages for both patients (treatment burden) and healthcare system (scheduling visits/treatments).


Eligibility

Min Age: 50 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is using artificial intelligence (AI) to help guide treatment decisions for adults with neovascular ("wet") age-related macular degeneration (AMD) — a leading cause of vision loss in older adults. Researchers will track how well patients do when their eye injections (anti-VEGF treatments) are managed using AI tools in a real-world clinical setting. You may be eligible if: - You are 50 years of age or older - You have active neovascular (wet) AMD in one eye, confirmed by imaging tests - Your vision in the study eye is at least 20/200 or better - You are willing to follow up with scheduled appointments You may NOT be eligible if: - You have a known allergy to fluorescein dye or the eye injection medications (ranibizumab, aflibercept, or brolucizumab) - You have had eye surgery in the study eye within the last 3 months - You have uncontrolled glaucoma in the study eye - You have active eye infections or inflammation - You have a retinal detachment or macular hole history in the study eye Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGanti-VEGF agent

All patients will be treated at baseline. A loading dose of 2 additionally monthly treatments will be performed at months 1 and 2. Patients showing no intra- and/or subretinal fluid in the central 1mm subfield at month 1, no treatment will be given till any disease activity is documented. Presence/change of sub- and intraretinal fluid will be assessed objectively by AI software and the results will be provided during the visit to the investigator. The final decision for/against retreatment is always made by the discretion of the clinical investigator. Should the Investigators decision differ from the study protocol, the reason will be indicated in the CRF.

DRUGanti-VEGF agent

All patients will be treated at baseline. A loading dose of 2 additionally monthly treatments will be performed at months 1 and 2. Patients showing no intra- and/or subretinal fluid in the central 1mm subfield at month 1, no treatment will be given till any disease activity is documented. In this cohort the amount of retinal fluid will not be assessed by AI software at the time of retreatment.


Locations(1)

Department of Ophthalmology, Medical University of Vienna, Austria

Vienna, State of Vienna, Austria

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NCT05093374


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