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
- Diseases
- Type 2 diabetes, Diabetic eye disease
- 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
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CS042 - Department of Ophthalmology, University Hospital, CHU Dijon Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
| CS067- Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffael, Milan Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| CS063 - Excellence Eye Research Centre, University G. d'Annunzio of Chieti-Pescara Coordinator of this site? Confirm its status | Pescara | Italy | Unknown status |
| CS020 - G. B. Bietti Eye Foundation - IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| CS001 Centre for Clinical Trials - AIBILI Coordinator of this site? Confirm its status | Coimbra | Portugal | Unknown status |
Related publications
- One-Year Progression of Capillary Nonperfusion in Nonproliferative Diabetic Retinopathy Using Noninvasive Imaging: The CHART Study.Transl Vis Sci Technol · 2026 · PMID 41569021
This page is information, not medical advice. Discuss any trial with your doctor.