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Not Yet Recruiting NCT05698316

A Collaborative Resource of Heidelberg Multimodal Imaging of Intermediate and Early Atrophic AMD Cases to Study Prediction of Disease Progression

Conditions: Age Related Macular Degeneration, Intermediate AMD, Atrophy, Prediction

Sex: All
Enrollment: 1000
Sponsor: Association for Innovation and Biomedical Research on Light and Image

Summary

This is a multicentre retrospective and prospective cohort study with the goal to develop a well-characterised multimodal image database of eyes with intermediate AMD with and without early atrophy. The main objectives are:Develop a collaborative well-characterised database on intermediate AMD with or without early atrophy.Grading of these images to explore imaging markers of progression.Develop predictive models as a secondary analysis of our dataset.This study will recruit around 1.000 eyes in 6 months. All consenting patients who have had at least 3 clinic visits with multimodal imaging done at least at 6 months interval between 2 visits and meet the inclusion and exclusion criteria will be included in the study for retrospective data collection. Those with one visit remaining to complete 2 years, images will be acquired prospectively. In addition to the images, routine demographic data (age and sex) and available visual acuity (VA) (BCVA if possible, VA with Pinhole or VA with patient's glasses) will be collected. Multimodal imaging includes mandated macular OCT with or without enhanced depth imaging and infrared imaging. Fundus autofluorescence (AF) and multicolor imaging are optional. All imaging must be done on Heidelberg Spectralis system.

Eligibility Criteria

Inclusion Criteria:Each dataset per patient should have one eye as the study eye with:Intermediate AMD with no atrophy and no subretinal drusenoid depositsIntermediate AMD with no atrophy with subretinal drusenoid depositsIntermediate AMD with early atrophy (iRORA) with no Subretinal drusenoid depositsIntermediate AMD with early atrophy (iRORA) with Subretinal drusenoid depositsIntermediate AMD with evidence of cRORANon-study eye images will not be exported but information about the status of the macula should be added using the following options:Established Geographic Atrophy (cRORA)Exudative AMD (presence of MNV)Early AMDHealthy maculaExclusion Criteria:Both eyes have exudative AMD or geographic atrophy at baseline.Co-existent ocular disease: Any other ocular condition that, in the investigator's opinion, might affect or alter visual acuity during the study.Any patient who has opted out of their information being used for research nationally or locally at any Member Site.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05698316). StuddyBuddy aggregates publicly available trial information.