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 clinical trial is studying a drug called anti-VEGF agent and a drug called anti-VEGF agent for people with exudative macular degeneration. The study is currently recruiting participants at 1 location. People eligible for this study include aged 50 Years to 100 Years.

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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