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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-99
SponsorMedical University of Vienna

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

Medical University of Vienna

Lead sponsor

University Medical Centre Ljubljana

Collaborator

Centre Hospitalier Universitaire Dijon

Collaborator

University of Zurich

Collaborator

Vista Klinik

Collaborator

Queen's University, Belfast

Collaborator

Fundacion Clinic per a la Recerca Biomédica

Collaborator