Not yet recruiting NCT07604545
A Study to Assess the Use of Artificial Intellignce to Predict Eye Treatment Changes in Adult Participants With Diabetic Macular Edema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diabetic Macular Edema. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Predictive Value of OCT Inflammatory Biomarkers in DME Using AI Analysis
Overview
This study is to assess the use of Artificial intellignce (AI) to predict eye treatment changes in adult participants with diabetic macular edema (DME).
Primary outcome measures
- Proportion of participants gaining ≥10 Early treatment diabetic retinopathy study (ETDRS) letters Best Corrected Visual Acuity (BCVA) [Time frame: Up to 3 months]
Eligibility criteria
Inclusion criteria
- Previously untreated Diabetic macular edema (DME) Participants.
- Baseline macular edema ≥350 microns confirmed on Spectralis Standard deviation (SD)-Optical coherence tomography (OCT) or equivalent.
- Baseline Best corrected visual acuity (BCVA) between 23 and 78 Early treatment diabetic retinopathy study (ETDRS) letters (between 20/32 and 20/230 Snellen).
Exclusion criteria
- History of eyes with previous intravitreal or laser treatment for DME.
- History of eyes with previous intraocular or periocular corticosteroid for DME.
- History eyes with other macular disease, causing visual reduction or disturbance.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07604545 · H25-796