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 range35 Years – 90 Years
SexALL
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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).
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