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

Launched by MEDICAL UNIVERSITY OF VIENNA · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on studying a type of eye condition called Age-Related Macular Degeneration (AMD), specifically a form known as atrophic AMD, which does not significantly affect vision at the moment. The goal is to understand how this condition progresses over two years in individual patients. Researchers will use advanced imaging techniques to closely monitor changes in the retina and to predict how quickly the disease may worsen for each person. Although there is currently no treatment available in Europe for this specific form of AMD, the study aims to gather important information that could help if treatments become available in the future.

To participate in this study, individuals must be between 55 and 99 years old and have specific signs of atrophic AMD in their eyes. This trial will not involve any treatments, but participants will receive regular eye exams and imaging tests every six months to track their condition. It's a chance to contribute to important research that could benefit many others with AMD in the future.

Gender

ALL

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.