Last reviewed · How we verify
NCT06582472: 2022-12376008
Early Retinal Neurodegeneration As Risk Factor, Biomarker and Pharmacological Target of Diabetic Retinopathy
trial testing Ophthalmological examination including imaging assessments in Diabetic Retinopathy in 180 participants. Currently enrolling.
19 May 2025
Quick facts
| Lead sponsor | IRCCS Ospedale San Raffaele |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 180 |
| Start date | 29 September 2023 |
| Primary completion | 19 May 2025 |
| Estimated completion | 19 May 2025 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Ophthalmological examination including imaging assessments
- confocal analysis of cornea
- Dynamic Vessel Analyzer (DVA)
- tear sampling collection
- blood sampling collection
Conditions studied
- Diabetic Retinopathy — all drugs for Diabetic Retinopathy →
- Diabetic Retinopathy Associated with Type 2 Diabetes Mellitus — all drugs for Diabetic Retinopathy Associated with Type 2 Diabetes Mellitus →
Sponsor
IRCCS Ospedale San Raffaele — full company profile →
Who can join
Adults 40 to 80, any sex, with Diabetic Retinopathy or Diabetic Retinopathy Associated with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Despite the evidence that diabetic retinopathy (DR) remains the first cause of blindness among the working-age population, it lacks a specific preventive treatment. This is because early mechanisms leading to the development of DR have been, until recently, unknown. Recent studies have suggested that the early stages of DR could be preceded by neuronal abnormalities, in particular retinal ganglion cell death, coupled with widespread retinal inflammation. According to these studies, endothelial dysfunction and the development of microaneurysms, the classic hallmarks of DR, could be the consequence of these early abnormalities. This project will aim to verify whether neurodegeneration could represent at the same time: 1) a risk factor for subsequent development of DR (this will be investigated through a follow-up study in type 2 diabetic patients free of diabetic retinopathy). 2) a biomarker of the complication (if so, patients with long-standing diabetes in the absence of retinopathy should show no signs of neurodegeneration).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06582472
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other IRCCS Ospedale San Raffaele trials
Trials by the same sponsor.
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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 NCT06582472 (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 IRCCS Ospedale San Raffaele
- Last refreshed: 3 September 2024
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/NCT06582472.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing