AI Prediction of Treatment Response in DME (NCT07707856) | Clinical Trial Compass
CompletedNot Applicable
AI Prediction of Treatment Response in DME
Egypt1,284 participantsStarted 2025-05-15
Plain-language summary
Diabetic macular edema (DME) is a leading cause of vision loss among individuals with diabetes mellitus. Although intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy is the standard treatment for center-involved DME, treatment response varies considerably between patients. Recent advances in artificial intelligence (AI), including machine learning (ML) and deep learning (DL), have enabled automated analysis of retinal imaging biomarkers to predict anatomical and functional treatment outcomes. This study aims to systematically evaluate published evidence regarding AI-based prediction models and imaging biomarkers used to predict treatment response in patients with DME. The review will assess the predictive performance of AI models, identify the most important imaging biomarkers, compare different AI approaches and imaging modalities, and summarize methodological strengths, limitations, and research gaps to support future development of precision ophthalmology.
Who can participate
Age range
18 Years
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:
* Adults aged 18 years or older.
* Diagnosis of diabetic macular edema (DME) confirmed by clinical examination and optical coherence tomography (OCT).
* Treatment with intravitreal anti-vascular endothelial growth factor (anti-VEGF), intravitreal corticosteroids, focal/grid laser photocoagulation, or combination therapy.
* Availability of baseline retinal imaging, including OCT, OCT angiography (OCTA), fundus photography, or multimodal imaging suitable for artificial intelligence analysis.
* Availability of baseline and follow-up best-corrected visual acuity (BCVA) and central retinal thickness (CRT) measurements.
* Complete demographic and clinical data required for model development or validation.
* Minimum follow-up of 3 months after initiation of treatment.
Exclusion Criteria:
* Macular edema due to causes other than diabetes.
* Previous vitreoretinal surgery in the study eye.
* Coexisting retinal diseases that may affect visual or anatomical outcomes (e.g., retinal vein occlusion, age-related macular degeneration, uveitis, inherited retinal disorders).
* Significant media opacity resulting in poor-quality retinal imaging.
* Incomplete clinical records or missing imaging data.
* Follow-up duration less than 3 months.
* Images that fail quality-control criteria for artificial intelligence analysis.
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
Predictive Performance of the Artificial Intelligence Model for Treatment Response