Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression

Last updated: May 12, 2025
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aging

Macular Degeneration

Myopic Macular Degeneration

Treatment

N/A

Clinical Study ID

NCT06351657
1088/2024
  • Ages 55-99
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 55-99 years old

  • Complete RPE and outer retinal atrophy (cRORA). This is (1) a region ofhypertransmission of at least 250 µm in diameter, (2) a zone of attenuation ordisruption of the RPE of at least 250 µm in diameter, (3) evidence of overlyingphotoreceptor degeneration, and (4) absence of scrolled RPE or other signs of an RPEtear.

  • If both eyes are eligible, both eyes will be included in the cohort study.

  • Clear optical media and adequate pupillary dilation for imaging and functionaltestin

Exclusion

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 studyeye

  • 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 ormoderate/severe diabetic retinopathy) that, in the opinion of the investigator, willmost likely require medical or surgical intervention during the study period toprevent or treat visual loss that might result from that condition

  • Any concurrent intraocular condition in the study eye that, in the opinion of theinvestigator, could cause an unwanted effect on treatment efficacy, compliance orrequire intraocular surgery (except for cataract surgery and YAG capsulotomy) duringthe 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 refractivesurgery: History of refractive error larger than 6 diopters.

  • Intake of drugs known to cause retinal toxicity (e.g. hydroxychloroquine ortamoxifen)

  • Presence of active macular neovascularization at baseline.

Study Design

Total Participants: 200
Study Start date:
April 11, 2025
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Medical University of Vienna

    Vienna,
    Austria

    Site Not Available

  • CHU Dijon

    Dijon,
    France

    Active - Recruiting

  • University Medical Center Ljubljana

    Ljubljana,
    Slovenia

    Active - Recruiting

  • Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed

    Barcelona,
    Spain

    Active - Recruiting

  • Vista Klinik Binningen

    Binningen,
    Switzerland

    Active - Recruiting

  • University of Zürich

    Zürich,
    Switzerland

    Active - Recruiting

  • Queen's Unviversity Belfast

    Belfast,
    United Kingdom

    Active - Recruiting

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