Actively Recruiting
Personalized Treatment Using Automated Fluid Analysis in Active Neovascular Age-related Macular Degeneration: Prospective Multicenter Randomized Study
Led by Medical University of Vienna · Updated on 2024-11-25
290
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Neovascular age-related macular degeneration (nAMD) is a chronic eye condition that requires ongoing follow-up and treatment to prevent vision loss. This trial evaluates the use of artificial intelligence (AI) tools to improve treatment decisions in real-world settings, aiming to reduce treatment burden for patients and improve scheduling for healthcare systems. The study compares standard care approaches with AI-assisted fluid quantification to better manage disease activity. Participants receive an anti-VEGF drug treatment starting with a baseline dose followed by two monthly doses. They are then monitored monthly for signs of active disease, such as vision loss or retinal fluid changes. One group will have fluid volumes measured by AI software to guide retreatment decisions, while the other group will be treated based on clinical judgment without AI fluid assessment. Treatment decisions remain at the investigator's discretion throughout. During the 12-month study, patients attend monthly visits for eye examinations, visual acuity tests, and fluid assessments using AI software or standard methods. Researchers will track the number of injections, vision changes, retinal fluid volumes, and other eye health measures. Quality of life questionnaires and detailed retinal imaging will also be collected. This thorough monitoring aims to assess the benefits of AI-assisted treatment in a routine clinical environment.
CONDITIONS
Brief Title
Treatment of Neovascular AMD: Artificial Intelligence in Real-world Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 50 years or older
- Active neovascular AMD confirmed by OCT, OCTA, or fluorescein angiography
- Best corrected visual acuity score of 0.1 (20/200) or better in the study eye
- No significant fibrosis or geographic atrophy involving the fovea
- Ability and willingness to follow study visits and procedures
- Signed informed consent form
You will not qualify if you...
- Allergy to fluorescein, ranibizumab, aflibercept, brolucizumab, or any related substances
- Eye surgery in the study eye within 3 months before starting the study
- History of pseudophakic cystoid macular edema
- Recent glaucoma filtration surgery, corneal transplant, cataract surgery with complications within the past 6 to 12 months
- Uncontrolled glaucoma in the study eye
- Aphakia in the study eye
- Retinal pigment epithelial tear involving the macula
- Other eye conditions likely to require treatment during the study period
- Active eye inflammation or infection in the study eye
- Vitreous hemorrhage or history of retinal detachment or macular hole in the study eye
- Iris neovascularization, vitreous hemorrhage, or retinal detachment
- Current infections of eyelid or eye surface
- Corneal damage affecting vision
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive an initial injection of an anti-VEGF agent at baseline, followed by two additional monthly treatments. Monthly follow-up visits occur to assess disease activity using AI-assisted fluid quantification for Cohort 1 or clinical criteria for Cohort 2, guiding retreatment decisions.
Monthly visits for 12 months
Trial Site Locations
Total: 1 location
1
Department of Ophthalmology, Medical University of Vienna, Austria
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
Research Team
S
Stefan Sacu, MD
U
Ursula Schmidt-Erfurth, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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