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

Sponsor: Medical University of Vienna

NCT ID: NCT06351657

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 27 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), specifically a form called geographic atrophy. It uses artificial intelligence (AI) to monitor areas of the eye not used for sharp central vision, to help spot when the disease gets worse.

Who can take part

  • People aged 55 to 99 years.
  • Having a specific type of eye change called complete retinal pigment epithelium and outer retinal atrophy (cRORA) — a defined area of thinning and damage in the light-sensitive part of the eye.
  • Being able to have clear eye scans, which needs clear eye tissues and pupil widening with drops.
  • If both eyes qualify, both may be included.

Who may not be able to

  • Eye surgery in the study eye within 3 months before the start of the study.
  • Past anti-VEGF injections (a type of eye treatment) in the study eye before the study starts.
  • A history of a type of eye swelling called pseudophakic cystoid macular oedema (Irvine Gass syndrome) in the study eye.
  • Uncontrolled glaucoma (high eye pressure despite treatment) or a very large cup-to-disc ratio.
  • Other eye conditions likely to need treatment or surgery during the study, or that could affect the results.
  • Corneal problems such as swelling, cloudiness or scarring affecting best-corrected vision.
  • Very strong glasses prescription (more than 6 dioptres), including in the past.
  • Taking medicines known to harm the retina, such as hydroxychloroquine or tamoxifen.
  • Active new abnormal blood vessel growth in the macula at the start of the study.

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
200
Started
2025-04-11
Last checked
2025-05

Plain English Summary

What is this study?

  • • Testing a new treatment for age-related macular degeneration
  • • Clinical study - 200 participants
  • • 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

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 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.

Age-Related Macular DegenerationGeographic Atrophy

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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
  • ✓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

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 * 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.

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