NCT07707856Completed
AI Prediction of Treatment Response in DME
Artificial Intelligence and Imaging Biomarkers for Predicting Treatment Response in Diabetic Macular Edema: A Systematic Review
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1284 (actual)
- First submitted
- 10 Jul 2026
- Start date
- 15 May 2025
- Primary completion date
- 22 Jun 2025
- Lead sponsor
- Benha University
- Diseases
- Diabetic eye disease
- NCT number
- NCT07707856
What you commit to
- Study type: Observational
- Participants enrolled: 1284
- From 15 May 2025 to the primary completion date, 22 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous vitreoretinal surgery in the study eye.
Other illness
- Macular edema due to causes other than diabetes.
Age
- Coexisting retinal diseases that may affect visual or anatomical outcomes (e.g., retinal vein occlusion, age-related macular degeneration, uveitis, inherited retinal disorders).
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Benha University Coordinator of this site? Confirm its status | Banhā | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.