Monitoring progression of non-foveal age-related macular degeneration using artificial intelligence

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.