Monitoring age-related macular degeneration using artificial intelligence
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
Medical University of Vienna · NCT06351670
This study is testing if using artificial intelligence with advanced imaging can help track how early and intermediate age-related macular degeneration progresses in people aged 55-99 over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 55 Years to 99 Years |
| Sex | All |
| Sponsor | Medical University of Vienna (other) |
| Locations | 7 sites (Vienna and 6 other locations) |
| Trial ID | NCT06351670 on ClinicalTrials.gov |
What this trial studies
This observational study aims to predict the progression of early and intermediate age-related macular degeneration (AMD) to advanced AMD over a two-year period. It will utilize advanced imaging techniques to identify changes in the retina and assess individual risk factors for disease progression. Patients aged 55-99 with early or intermediate AMD will be monitored at six-month intervals to evaluate clinical changes. The study seeks to enhance AMD classification through the integration of artificial intelligence with traditional assessment methods.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55-99 with early or intermediate AMD in at least one eye.
Not a fit: Patients who have undergone recent eye surgery or have certain ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and early intervention strategies for patients with age-related macular degeneration.
How similar studies have performed: Other studies have shown promise in using artificial intelligence for disease monitoring, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna and 6 other locations
- Medical University of Vienna — Vienna, Austria (NOT_YET_RECRUITING)
- CHU Dijon — Dijon, France (RECRUITING)
- University Medical Center Ljubljana — Ljubljana, Slovenia (RECRUITING)
- Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed — Barcelona, Spain (RECRUITING)
- Vista Klinik Binningen — Binningen, Switzerland (RECRUITING)
- University of Zürich — Zurich, Switzerland (RECRUITING)
- Queen's Unviversity Belfast — Belfast, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Gregor Reiter, Priv.-Doz. Ing. DDr., BA MSc
- Email: gregor.reiter@meduniwien.ac.at
- Phone: +43 1 40400-73419
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Age-Related Macular Degeneration