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

NCT ID: NCT06351670

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2027-07-31

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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.

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: collaborator

Vista Klinik

OTHER

Sponsor Role: collaborator

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Gregor Reiter

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: NOT_YET_RECRUITING

CHU Dijon

Dijon, , France

Site Status: RECRUITING

University Medical Center Ljubljana

Ljubljana, , Slovenia

Site Status: RECRUITING

Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed

Barcelona, , Spain

Site Status: RECRUITING

Vista Klinik Binningen

Binningen, , Switzerland

Site Status: RECRUITING

University of Zürich

Zurich, , Switzerland

Site Status: RECRUITING

Queen's Unviversity Belfast

Belfast, , United Kingdom

Site Status: RECRUITING

Countries

Austria; France; Slovenia; Spain; Switzerland; United Kingdom

Central Contacts

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

Role: CONTACT

gregor.reiter@meduniwien.ac.at

+43 1 40400-73419

Facility Contacts

Gregor S Reiter, MD, PhD

Role: primary

gregor.reiter@meduniwien.ac.at

+4314040073419

Catherine Creuzot-Garcher, MD

Role: primary

catherine.creuzot-garcher@chu-dijon.fr

+33380293756

Polona Jaki-Mekjavic, MD

Role: primary

polona.jakimekjavic@kclj.si

+38615221900

Javier Zarranz-Ventura, MD

Role: primary

zarranz@clinic.cat

+34 617 92 62 50

Katja Hatz, MD

Role: primary

Katja.Hatz@vista.ch

+41 61 426 60 79

Daniel Barthelmes, MD

Role: primary

Daniel.Barthelmes@usz.ch

+41 43 253 05 98

Ruth Hogg, MD

Role: primary

r.e.hogg@qub.ac.uk

+44(0)7734671087

Other Identifiers

1109/2024

Identifier Type: -

Identifier Source: org_study_id