NCT06351657Recruiting
Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression in a Prospective, Multinational, Multicenter 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 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 2 Apr 2024
- Start date
- 11 Apr 2025
- Primary completion date
- Jul 2027
- Lead sponsor
- Medical University of Vienna
- Diseases
- Macular degeneration
- NCT number
- NCT06351657
What you commit to
- Study type: Observational
- Planned participants: 200
- From 11 Apr 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
- Complete RPE and outer retinal atrophy (cRORA). This is (1) a region of hypertransmission of at least 250 µm in diameter, (2) a zone of attenuation or disruption of the RPE of at least 250 µm in diameter, (3) evidence of overlying photoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPE tear.
- 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 testin
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.