Clinical trial NCT06351670: Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
Official title: Personalised Monitoring of Early and Intermediate Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression in a Prospective, Multinational, Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Age-Related Macular Degeneration
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: University Medical Centre Ljubljana
name: Centre Hospitalier Universitaire Dijon
name: Queen's University, Belfast
name: University of Zurich
name: Vista Klinik
name: Fundacion Clinic per a la Recerca Biomédica
First posted: 2024-04-08
Enrollment: 500
Sex: ALL
Minimum age (years): 55
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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).

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.


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

Primary outcomes:
measure: To characterise and quantify focal and global changes of the retina by retinal imaging to identify patients at risk for conversion to advanced AMD.
timeFrame: 2 years
Secondary outcomes:
measure: To identify and quantify disease progression-related biomarkers
timeFrame: 2 years
measure: To evaluate monitoring of AMD progression assisted by AI algorithms
timeFrame: 2 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Dijon
country: France
facility: CHU Dijon
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
city: Barcelona
country: Spain
facility: Fundacio de Recerca Clinic Barcelona-Institut D Investigacions Biomed
city: Binningen
country: Switzerland
facility: Vista Klinik Binningen
city: Zürich
country: Switzerland
facility: University of Zürich
city: Belfast
country: United Kingdom
facility: Queen's Unviversity Belfast
Study officials:
References: