NCT06351670 Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
| NCT ID | NCT06351670 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Age-Related Macular Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-02-25 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Any surgical treatment of the eye within 3 months prior to baseline in the study eye * History of anti-VEGF treatment in the study eye before baseline * History of pseudophakic cystoid macular edema (Irvine Gass Syndrome) 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 * Presence of corneal decompensation, haze or scarring with an impact on BCVA * Refractive error larger than 6 diopters. In case of pseudophakia or refractive surgery: History of refractive error larger than 6 diopters. * Intake of drugs known to cause retinal toxicity (e.g. hydroxychloroquine or tamoxifen) * Presence of active macular neovascularization at baseline
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06351670 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 99 Years, studying Age-Related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06351670 currently recruiting?
Yes, NCT06351670 is actively recruiting participants. Contact the research team at gregor.reiter@meduniwien.ac.at for enrollment information.
Where is the NCT06351670 trial being conducted?
This trial is being conducted at Vienna, Austria, Dijon, France, Ljubljana, Slovenia, Barcelona, Spain and 3 additional locations.
Who is sponsoring the NCT06351670 clinical trial?
NCT06351670 is sponsored by Medical University of Vienna. The trial plans to enroll 500 participants.