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

NCT04636307 | Completed

• 1 other identifier: ECR-RET-2020-15
• Study Type: observational
• Target: 202
• Locations: 3 countries
• Sites: 5

Brief Summary

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).

Conditions

NPDR - Non Proliferative Diabetic Retinopathy; Diabetes Mellitus, Type 2; Retinal Disease

Outcome Measures

Primary Outcomes (3)

• DRSS severity progression

  DRSS severity progression of one, two or more ETDRS step changes

  36 months

• Progression to vision-threatening complications

  CIME defined as eyes with a CRT ≥ 290 μm in women and ≥ 305 μm in men (Zeiss Cirrus SD-OCT); CSME identified on clinical evaluation as defined by ETDRS by retinal thickening within 500 μm of the center of the fovea or presence of hard exudates (with thickening of the adjacent retina) within 500 μm of the center of the fovea, or thickening of at least 1 disc area located less than 1 disc diameter from the center of the fovea. (Zeiss Cirrus SD-OCT); PDR identified by the presence of abnormal new vessels in the retina.

  36 months

• Presence of ischemia

  dentified by decrease of 2 or more Standard deviations (in relation to healthy control population) on the values of vessel density, perfusion density or FAZ circularity.

  36 months

Interventions

Biomarkers OTHER

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 NPDR.

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetes Type-2 and NPDR (levels 35, 43, 47 or 53)

You may qualify if:

• 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.

You may not qualify if:

• Repeated HbA1C \> 10% in the first visit;
• Cataract or other eye disease that may interfere with fundus examinations;
• 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;
• Any eye surgery within a period of 6-months;
• Previous laser treatment or previous intravitreal injections;
• Any patient comorbidity likely to affect the eye and not related with diabetes or cardiovascular disease;
• 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;
• Uncontrolled systemic hypertension (values outside normal range: systolic 70-210 mmHg and diastolic 50-120 mmHg).

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead
• European Vision Institute Clinical Research Network: collaborator

Study Sites (5)

CS042 - Department of Ophthalmology, University Hospital, CHU Dijon

Dijon, France

Location

CS067- Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffael, Milan

Milan, Italy

Location

CS063 - Excellence Eye Research Centre, University G. d'Annunzio of Chieti-Pescara

Pescara, Italy

Location

CS020 - G. B. Bietti Eye Foundation - IRCCS

Roma, Italy

Location

CS001 Centre for Clinical Trials - AIBILI

Coimbra, Portugal

Location

Related Publications (1)

• Marques IP, Reste-Ferreira D, Santos T, Mendes L, Rocha AC, Bandello F, Parravano M, Mastropasqua L, Creuzot-Garcher C, Leal S, Baschiera F, Cunha-Vaz J. One-Year Progression of Capillary Nonperfusion in Nonproliferative Diabetic Retinopathy Using Noninvasive Imaging: The CHART Study. Transl Vis Sci Technol. 2026 Jan 5;15(1):26. doi: 10.1167/tvst.15.1.26.

  PMID: 41569021 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Retinal Diseases

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 19, 2020
• Study Start: September 22, 2021
• Primary Completion: March 21, 2023
• Study Completion: May 22, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (3); PT (1); FR (1)