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RECRUITING
NCT05093374
PHASE4

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

Sponsor: Medical University of Vienna

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

50 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

290

Start Date

2021-03-01

Completion Date

2025-12-31

Last Updated

2024-11-25

Healthy Volunteers

No

Interventions

DRUG

anti-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.

DRUG

anti-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, Vienna, Austria