Brief Summary

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).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

180

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Sep 2023

Geographic Reach

1 country

2 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.6 years study duration

Study Start

First participant enrolled

September 29, 2023

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2024

Completed

8 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2025

Completed

Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

1.6 years

First QC Date

August 26, 2024

Last Update Submit

August 30, 2024

Conditions

Diabetic Retinopathy Diabetic Retinopathy Associated with Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

imaging assessment (OCT, Optical coherence tomography; OCT-A, Optical Coherence Tomography Angiography and Dynamic Vessel Analyzer); confocal microscopy, blood sampling collection and conjunctival impression cytology
* Evaluation of changes in neuroretinal morphology by OCT (Optical coherence tomography), in the morphology of the retinal vascular component by OCT-A, and retinal blood perfusion due to the presence/absence of a light signal by Dynamic Vessel Analyzer); * identification of retinal neurodegeneration factors as possible biomarkers of diabetic retinopathy, using conjunctival impression cytology and quantum/qualitative analysis of pro-inflammatory cytokines in tears and plasma; * assessment of the appearance of signs of corneal nerve degeneration by confocal microscopy in patients with signs of overt retinal neurodegeneration.
24 months

Secondary Outcomes (1)

imaging assessment (OCT, Optical coherence tomography; OCT-A, Optical Coherence Tomography Angiography and Dynamic Vessel Analyzer); confocal microscopy, blood sampling collection and conjunctival impression cytology
24 months

Study Arms (4)

cohort 1 (longitudinal study)

This group will include patients affected by type 2 diabetes for less than 10 years and without signs of diabetic retinopathy, nephropathy, and neuropathy.

Procedure: Ophthalmological examination including imaging assessmentsProcedure: confocal analysis of corneaProcedure: Dynamic Vessel Analyzer (DVA)Procedure: tear sampling collectionProcedure: blood sampling collection

cohort 2 (longitudinal study)

healthy controls: subjects in good general health as evidenced by medical history without diagnosis of type 2 diabetes

cohort 1 (cross sectional study)

Patients with a diagnosis of type 2 diabetes for longer than 20 years without clinical signs of retinopathy and other diabetic complications

cohort 2 (cross sectional study)

Patients with a diagnosis of type 2 diabetes for longer than 20 years with clinical signs of retinopathy and other diabetic complications

Interventions

Ophthalmological examination including imaging assessmentsPROCEDURE

Ophthalmological examination including imaging assessments (SD-OCT, Spectral Domain Optical Coherence Tomography, a procedure to study and quantify possible retinal neurodegeneration and OCT-A, Optical coherence tomography angiography, a procedure to study and quantify possible retinal vascular abnormalities)