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NCT Number: NCT06351657

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

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Geographic Atrophy Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

55 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for fast geographic atrophy (GA) progression

    Time frame: 2 years

    The association between biomarkers and GA progression will be assessed by linear mixed models. Artificial intelligence models will be applied to assess progression speed and predict local and global progression.

    Mixed Effects models will be calculated to estimate the association between the above mentioned independent variables, including the timepoint as an independent variable, on individual markers of progression (RPE and PR thinning).

    The r-squared value of the predicted increase in atrophy area will be used as an endpoint assessment to evaluate the predictive model.

Secondary outcomes

  1. To identify and quantify disease progression-related biomarkers

    Time frame: 2 years

    Longitudinal assessments of imaging biomarkers are performed in a descriptive manner. The following biomarkers will be evaluated in detail as independent variables:

    • Hyperreflective Foci (HRF) (scale, nL)
    • Drusen volume/Refractile drusen (scale, nL)
    • Subretinal Drusenoid Deposits (SDD) (scale, mm2)
    • PR loss/RPE loss ratio (scale, ratio)
    • GA lesion size (mm2)
    • Foveal involvement (categorical; yes or no)
    • Thinning of outer retinal layers (PR thinning) (scale, µm)
    • Other retinal biomarkers if relevant to the progression of GA

    The association between biomarkers and GA progression will be assessed by linear mixed models.

  2. To evaluate monitoring AMD progression using approved AI algorithms.

    Time frame: 2 years

    The following will be provided by AI-based image analysis of the GA Monitor (independent variables):

    • RPE integrity loss (mm2) in the 1mm central area, 6mm area, and the respective relative change to previous visit
    • PR integrity loss (mm2) in the 1mm central area, 6mm area, and the respective relative change to previous visit

Study contacts

Contact information is provided by the study sponsor or research team.

Gregor Reiter, Priv.-Doz. Ing. DDr., BA MSc

CONTACT

[email protected]

+43 1 40400-73419

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • Centre Hospitalier Universitaire Dijon
  • Fundacion Clinic per a la Recerca Biomédica
  • Queen's University, Belfast
  • University Medical Centre Ljubljana
  • University of Zurich
  • Vista Klinik

Registry information

Official study title

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

Acronym: APENNINES

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2024
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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