Monitoring progression of non-foveal age-related macular degeneration using artificial intelligence
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
This study is testing how well artificial intelligence can help track the progression of a specific type of age-related macular degeneration in patients over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 55 Years to 99 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 7 sites (Vienna and 6 other locations) |
| Trial ID | NCT06351657 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess and predict the progression of non-foveal, non-vision compromising atrophic age-related macular degeneration (AMD) over a two-year period. It will evaluate individual progression rates and personalized risks based on advanced imaging techniques, including Optical Coherence Tomography and Fundus Photography. Patients will be monitored every six months to identify changes in retinal health and disease progression using approved AI algorithms. The study involves multiple centers across different countries to gather diverse data.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55-99 with specific retinal atrophy characteristics and clear optical media for imaging.
Not a fit: Patients who have had recent eye surgery or specific ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized monitoring strategies that improve patient outcomes in managing age-related macular degeneration.
How similar studies have performed: While similar studies have explored AMD monitoring, this approach utilizing AI for personalized risk assessment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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.