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

Sponsor: Medical University of Vienna

NCT ID: NCT06351670

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by the Medical University of Vienna, is looking at age-related macular degeneration (AMD) — an eye condition that can affect central vision. It uses artificial intelligence (computer-based analysis) to monitor people with early or intermediate AMD and to help spot when the disease gets worse.

Who can take part

  • Age 55 to 99 years
  • Early or intermediate AMD in at least one eye (small deposits under the retina called drusen, and/or changes in the back of the eye's colouring)
  • Clear areas within the eye and pupils that widen (dilate) enough for eye scans and vision tests
  • If both eyes are suitable, both may be included

Who may not be able to

  • Eye surgery in the study eye within 3 months before joining
  • Previous anti-VEGF (injection) treatment in the study eye
  • Past swelling in the centre of the retina after cataract surgery (Irvine Gass syndrome)
  • Uncontrolled glaucoma (high eye pressure despite treatment, or a very thinned optic nerve)
  • Another eye problem that is likely to need treatment or surgery during the study
  • Scarred or cloudy cornea (the clear front of the eye) affecting vision
  • Very strong glasses prescription (more than 6 dioptres), or this in the past if you have had cataract or laser eye surgery
  • Taking medicines that can harm the retina, such as hydroxychloroquine or tamoxifen
  • Active new blood vessel growth at the back of the eye (wet AMD) at the start

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
55 Years to 99 Years
Who
All
Number of participants
500
Started
2025-02-25
Last checked
2025-05

Plain English Summary

What is this study?

  • • Testing a new treatment for age-related macular degeneration
  • • Clinical study - 500 participants
  • • 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

Who can take part?

  • • Ages 55 Years to 99 Years
  • • Diagnosed with age-related macular degeneration

Where?

  • • Belfast - Queen's Unviversity Belfast

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Age-Related Macular Degeneration

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 55 Years - 99 Years
  • Who can join: All genders

What the study is looking for

  • ✓Age: 55-99 years old
  • ✓Early or intermediate AMD in at least one eye (drusen \> 63 µm and/or any definite hyper- or hypopigmentary...
  • ✓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.

Who cannot take part

  • ✗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...
  • ✗Presence of corneal decompensation, haze or scarring with an impact on BCVA
See the full 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

Where Is This Study? (1 UK site)

Queen's Unviversity Belfast

Belfast, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

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

Sponsor contact

CONTACT

+43 1 40400-73419 gregor.reiter@meduniwien.ac.at
Data sourced from ClinicalTrials.gov · Last verified: 2025-05