Clinical trial NCT06351657: Personalized Monitoring of Non-foveal, Non-vision Compromising Atrophic Age-related Macular Degeneration With Artificial Intelligence and Identification of Disease Progression
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Age-Related Macular Degeneration
Geographic Atrophy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: University Medical Centre Ljubljana
name: Centre Hospitalier Universitaire Dijon
name: University of Zurich
name: Vista Klinik
name: Queen's University, Belfast
name: Fundacion Clinic per a la Recerca Biomédica
First posted: 2024-04-08
Enrollment: 200
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 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 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.

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: To identify and quantify disease progression-related biomarkers
timeFrame: 2 years
measure: To evaluate monitoring AMD progression using approved 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: