NCT06351670Recruiting
Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression in a Prospective, Multinational, Multicentre Observational Study
Source: ClinicalTrials.gov · Last updated 15 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this prospective, multinational, multicenter observational study is to to predict conversion of early and intermediate AMD with functional vision to advanced AMD with irreversible loss of vision on an individual-based level over 2 years. The main objectives of this study are: * Identify and quantify focal and global alterations in the retina in regard to disease progression. * Assess the individual risk of disease progression in intermediate AMD patients converting to advanced AMD based on imaging. * Specify the course of disease in regard to the sequence of events that lead to the conversion to advanced AMD * Enhance the ability to classify AMD using artificial intelligence in addition to traditional models. 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 2 Apr 2024
- Start date
- 25 Feb 2025
- Primary completion date
- Jul 2027
- Lead sponsor
- Medical University of Vienna
- Diseases
- Macular degeneration
- NCT number
- NCT06351670
What you commit to
- Study type: Observational
- Planned participants: 500
- From 25 Feb 2025 to the primary completion date, Jul 2027
- 7 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any surgical treatment of the eye within 3 months prior to baseline in the study eye
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 25 mmHg despite treatment with IOP lowering medication), or C/D Ratio \> 0.9
- Any concurrent intraocular condition in the study eye (e.g. advanced cataract or moderate/severe diabetic retinopathy) that, in the opinion of the investigator, will most likely require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition
- Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could cause an unwanted effect on treatment efficacy, compliance or require intraocular surgery (except for cataract surgery and YAG capsulotomy) during the study period
- Intake of drugs known to cause retinal toxicity (e.g. hydroxychloroquine or tamoxifen)
Other illness
- History of anti-VEGF treatment in the study eye before baseline
- History of pseudophakic cystoid macular edema (Irvine Gass Syndrome) in the study eye
- Refractive error larger than 6 diopters. In case of pseudophakia or refractive surgery: History of refractive error larger than 6 diopters.
Other
- Presence of corneal decompensation, haze or scarring with an impact on BCVA
- Presence of active macular neovascularization at baseline
Who the study is looking for
- Age: 55-99 years old
- Early or intermediate AMD in at least one eye (drusen \> 63 µm and/or any definite hyper- or hypopigmentary abnormalities with or without reticular pseudodrusen)
- If both eyes are eligible, both eyes will be included in the cohort study.
- Clear optical media and adequate pupillary dilation for imaging and functional testing.
Age in the registry: 55 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Vista Klinik Binningen Coordinator of this site? Confirm its status | Binningen | Switzerland | Recruiting |
| University of Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| CHU Dijon Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Queen's Unviversity Belfast Coordinator of this site? Confirm its status | Belfast | United Kingdom | Recruiting |
| University Medical Center Ljubljana Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.