A Collaborative Resource of Heidelberg Multimodal Imaging of Intermediate and Early Atrophic AMD … (NCT05698316) | Clinical Trial Compass
CompletedNot Applicable
A Collaborative Resource of Heidelberg Multimodal Imaging of Intermediate and Early Atrophic AMD Cases to Study Prediction of Disease Progression
France, Germany, Ireland1,000 participantsStarted 2023-05-04
Plain-language 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:
1. Develop a collaborative well-characterised database on intermediate AMD with or without early atrophy.
2. Grading of these images to explore imaging markers of progression.
3. 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Each dataset per patient should have one eye as the study eye with:
* Intermediate AMD with no atrophy and no subretinal drusenoid deposits
* Intermediate AMD with no atrophy with subretinal drusenoid deposits
* Intermediate AMD with early atrophy (iRORA) with no Subretinal drusenoid deposits
* Intermediate AMD with early atrophy (iRORA) with Subretinal drusenoid deposits
* Intermediate AMD with evidence of cRORA
Non-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 AMD
* Healthy macula
Exclusion 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of conversion to atrophy at two years
Timeframe: 24 months
Trial details
NCT IDNCT05698316
SponsorAssociation for Innovation and Biomedical Research on Light and Image