Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression

NCT06351670 | Recruiting DMC

• 1 other identifier: 1109/2024
• Study Type: observational
• Target: 500
• Locations: 6 countries
• Sites: 7

Brief Summary

The goal of this prospective, multinational, multicenter observational study is to to predict conversion of early and intermediate AMD with functional vision to advanced AMD with irreversible loss of vision on an individual-based level over 2 years. The main objectives of this study are:

• Identify and quantify focal and global alterations in the retina in regard to disease progression.
• Assess the individual risk of disease progression in intermediate AMD patients converting to advanced AMD based on imaging.
• Specify the course of disease in regard to the sequence of events that lead to the conversion to advanced AMD
• Enhance the ability to classify AMD using artificial intelligence in addition to traditional models. 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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for conversion to advanced AMD.

  The correlation between biomarkers (independent variables) and progression will be assessed by linear mixed models or prospectively by Cox-regression 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 independent variables, including the timepoint as an independent variable, on individual markers of progression (PR thinning and PR loss expansion).

  2 years

Secondary Outcomes (2)

• To identify and quantify disease progression-related biomarkers

  2 years

• To evaluate monitoring of AMD progression assisted by AI algorithms

  2 years

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from each center's respective outpatient clinic and/or by referral from primary eye care (e.g. optometrist).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (7)

Medical University of Vienna

Vienna, 1090, 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

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

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

CONTACT

+43 1 40400-73419; gregor.reiter@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: February 25, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

CH (2); GB (1); ES (1); FR (1); SL (1); AU (1)