Actively Recruiting
Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
Led by Medical University of Vienna · Updated on 2025-05-15
200
Participants Needed
7
Research Sites
115 weeks
Total Duration
On this page
Sponsors
M
Medical University of Vienna
Lead Sponsor
U
University Medical Centre Ljubljana
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this prospective, multinational, multicenter observational study is to assess and predict progression in non-foveal, non-vision compromising atrophic AMD on an individual-based level over two years. The main objectives of this study are: * Assess the individual progression rate of a patient in non-foveal, non-vision compromising atrophic AMD and assess personalized risk of progression based on imaging. * Identify and quantify focal and global alterations in the retina in regard to disease progression. * Evaluate the monitoring of AMD progression using approved AI algorithms. All patients will be followed for 24 months with 6 month intervals to assess clinical changes. Monitoring of disease progression will be performed using the following routine in-vivo imaging procedures: * Scanning Laser Fundus Photography * Color Fundus Photography (CFP) * Optical Coherence Tomography (OCT) * Optical Coherence Tomography Angiography (OCTA) Patients will be asked for their medical history. Standard ophthalmic examination, as well as a questionnaire on visual function will be carried out. No intervention will be performed during the study since no treatment is yet available within Europe. As soon as treatment is approved in the EU, patients in this cohort might receive treatment according to availability in their respective country and standard of care. If treatment will be performed, it will be as standard of care outside the study according to each country's standard of care and by EMA label.
CONDITIONS
Official Title
Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 55 and 99 years
- Complete retinal pigment epithelium (RPE) and outer retinal atrophy (cRORA) with specific retinal features
- Both eyes can be included if eligible
- Clear optical media and good pupil dilation for imaging and testing
You will not qualify if you...
- Eye surgery within 3 months before baseline in the study eye
- Previous anti-VEGF treatment in the study eye before baseline
- History of pseudophakic cystoid macular edema in the study eye
- Uncontrolled glaucoma in the study eye (IOP ≥ 25 mmHg despite treatment) or cup-to-disc ratio over 0.9
- Other eye conditions requiring medical or surgical intervention during the study
- Eye conditions that could affect treatment efficacy or require surgery (except cataract surgery and YAG capsulotomy)
- Corneal problems affecting vision
- Refractive error larger than 6 diopters or history of such error in pseudophakia or after refractive surgery
- Use of drugs known to cause retinal toxicity (e.g., hydroxychloroquine, tamoxifen)
- Presence of active macular neovascularization at baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Medical University of Vienna
Vienna, Austria
Not Yet Recruiting
2
CHU Dijon
Dijon, France
Actively Recruiting
3
University Medical Center Ljubljana
Ljubljana, Slovenia
Actively Recruiting
4
Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed
Barcelona, Spain
Actively Recruiting
5
Vista Klinik Binningen
Binningen, Switzerland
Actively Recruiting
6
University of Zürich
Zurich, Switzerland
Actively Recruiting
7
Queen's Unviversity Belfast
Belfast, United Kingdom
Actively Recruiting
Research Team
G
Gregor Reiter, Priv.-Doz. Ing. DDr., BA MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here