Characterization of Retinal Disease Progression in Eyes With Non Proliferative Diabetic Retinopat… (NCT04636307) | Clinical Trial Compass
CompletedNot Applicable
Characterization of Retinal Disease Progression in Eyes With Non Proliferative Diabetic Retinopathy in Diabetes Type 2 Using Non-invasive Procedures (CHART)
France, Italy, Portugal202 participantsStarted 2021-09-22
Plain-language 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).
Who can participate
Age range
35 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA
* 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.
EXCLUSION CRITERIA
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
DRSS severity progression
Timeframe: 36 months
2
Progression to vision-threatening complications
Timeframe: 36 months
3
Presence of ischemia
Timeframe: 36 months
Trial details
NCT IDNCT04636307
SponsorAssociation for Innovation and Biomedical Research on Light and Image