Last reviewed · How we verify
NCT06782997: ERGDIAB
Performance of the Electroretinogram, Performed and Interpreted by an Advanced Practice Nurse, in the Screening for Diabetic Retinopathy.
trial testing Electroretinogram in Diabetic Retinopathy in 270 participants. Currently enrolling.
17 December 2026
Quick facts
| Lead sponsor | CHU de Reims |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 270 |
| Start date | 17 June 2025 |
| Primary completion | 17 December 2026 |
| Estimated completion | 17 December 2026 |
| Sites | 1 location across France |
Drugs / interventions tested
- Electroretinogram
Conditions studied
- Diabetic Retinopathy — all drugs for Diabetic Retinopathy →
Sponsor
CHU de Reims — full company profile →
Who can join
18 and older, any sex, with Diabetic Retinopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus and the leading cause of preventable blindness in working-age individuals. Early screening for DR is a public health issue. The gold standard is fundoscopy interpreted by an ophthalmologist. In France, in 2020, it was estimated that one-third of diabetic patients had not seen an ophthalmologist in over two years. Recently, a portable electroretinogram (ERG), which provides a physiological and non-invasive assessment of retinal cell function, has been developed. It combines pupillary responses through an infrared-sensitive camera, the implicit time and the response amplitude to brief white light stimuli. The result is expressed as an overall score (DR score), considered abnormal if it is \< 7 or \> 23.4. The sensitivity of the ERG for screening diabetic retinopathy is estimated at 80%, and its specificity at 82%, compared to conventional imaging. Additionally, it has been shown that poor glycemic control is associated with an increase in implicit time in preclinical DR. This test could therefore detect earlier changes than imaging results. To date, it is not considered the gold standard in France. The investigators aim to test this hypothesis. The investigators propose a prospective, bi-center study to evaluate the performance of the ERG, performed and interpreted by an Advanced Practice Nurse (APN), compared to the gold standard of retinal imaging (retinography) interpreted remotely by an ophthalmologist.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06782997
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Electroretinogram
Trials testing the same drug.
- NCT06972602 — High-dose Topotecan for Retinoblastoma With Recurrent or Refractory Vitreous Seed · EARLY_PHASE1 · recruiting
- NCT05543018 — Effect of Intraocular Tamponade on Visual Perception · NA · unknown
Other recruiting trials for Diabetic Retinopathy
Currently open trials in the same condition.
- NCT07255326 — Effect of Omega-3 Fatty Acids on Eye Blood Vessels in Type 1 Diabetes · NA · recruiting
- NCT07002372 — Effect of Video Viewing on Intravitreal Injection Experience · NA · recruiting
- NCT06713720 — Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy · NA · recruiting
- NCT06892353 — AI-Powered DIY Screening System for Diabetic Retinopathy · NA · recruiting
- NCT06821399 — Optimization and Evaluation of the Diagnosis and Treatment System for Diabetic Retinopathy in Type 2 Diabetes Mellitus · recruiting
Other CHU de Reims trials
Trials by the same sponsor.
- NCT06955767 — Measurement of MMP-14 Protein, a Potential New Marker for Colorectal Cancer Detection, in Plasma Vesicles Named Exosomes · NA · recruiting
- NCT07163338 — Prevalence and Consequences of Antiphospholipid Syndrome in Patients Aged 65 and Over With Ischemic Strokes (IS) · NA · recruiting
- NCT07274631 — A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine · recruiting
- NCT07016035 — Translation and Validation of the French mPCOSQ (mPCOSQ-F). · recruiting
- NCT06554327 — Ventilator Associated Pneumonia Multiplex PCR for Anti-Infective Regimens · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06782997 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CHU de Reims
- Last refreshed: 28 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06782997.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing