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NCT04636307Completed

Characterization of Retinal Disease Progression in Eyes With Non Proliferative Diabetic Retinopathy in Diabetes Type 2 Using Non-invasive Procedures (CHART)

Characterization of Retinal Disease Progression in Eyes With Non Proliferative Diabetic Retinopathy (NPDR) in Diabetes Type 2 Using Non-invasive Procedures (CHART)

Source: ClinicalTrials.gov · Last updated 5 Dec 2025

Brief summary (registry, in English)

To identify biomarkers, obtained using non-invasive procedures, that can predict disease progression and progression to sight-threatening stages of the disease and to characterize the retinal changes that occur in Non Proliferative Diabetic Retinopathy (NPDR).

Status (registry)
Completed
Study type
Observational
Enrollment
202 (actual)
First submitted
29 Oct 2020
Start date
22 Sept 2021
Primary completion date
21 Mar 2023
Lead sponsor
Association for Innovation and Biomedical Research on Light and Image
NCT number
NCT04636307

What you commit to

  • Study type: Observational
  • Participants enrolled: 202
  • From 22 Sept 2021 to the primary completion date, 21 Mar 2023
  • 5 sites in 3 countries
  • 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

  • Any eye surgery within a period of 6-months;
  • Previous laser treatment or previous intravitreal injections;

Other illness

  • Cataract or other eye disease that may interfere with fundus examinations;
  • Any patient comorbidity likely to affect the eye and not related with diabetes or cardiovascular disease;
  • Uncontrolled systemic hypertension (values outside normal range: systolic 70-210 mmHg and diastolic 50-120 mmHg).

Lab values

  • Repeated HbA1C \> 10% in the first visit;

Age

  • Age-related macular degeneration, glaucoma, vitreomacular disease, or other retinal vascular disease, or any ocular condition that, in the opinion of the investigator may affect retinopathy status or alter visual acuity during the study;

Other

  • Presence of CIME (CRT ≥ 290 μm in women and ≥ 305 μm in men) with vision loss or needing immediate treatment, according to clinical practice;
  • Dilatation of the pupil \< 5 mm;

Who the study is looking for

  • Diabetes type 2 according to 1985 WHO criteria;
  • Age between 35 and 90 years;
  • NPDR levels 35, 43, 47 or 53 (based on the ETDRS criteria - 7 fields CFP) after confirmation by the Reading Centre;
  • Refraction with a spherical equivalent less than 5 Dp;
  • Informed consent.

Age in the registry: 35 years to 90 years · Sex: All

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CS042 - Department of Ophthalmology, University Hospital, CHU Dijon
Coordinator of this site? Confirm its status
DijonFranceUnknown status
CS067- Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffael, Milan
Coordinator of this site? Confirm its status
MilanItalyUnknown status
CS063 - Excellence Eye Research Centre, University G. d'Annunzio of Chieti-Pescara
Coordinator of this site? Confirm its status
PescaraItalyUnknown status
CS020 - G. B. Bietti Eye Foundation - IRCCS
Coordinator of this site? Confirm its status
RomaItalyUnknown status
CS001 Centre for Clinical Trials - AIBILI
Coordinator of this site? Confirm its status
CoimbraPortugalUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.