Characterization of Retinal Vascular Disease in Eyes With Mild to Moderate NPDR in Diabetes Type 2 (NCT03696810) | Clinical Trial Compass
CompletedNot Applicable
Characterization of Retinal Vascular Disease in Eyes With Mild to Moderate NPDR in Diabetes Type 2
Portugal141 participantsStarted 2018-10-30
Plain-language summary
Characterization of Retinal vascular disease in eyes with mild to moderate NPDR in Diabetes type 2, using novel non-invasive Imaging methods, in a longitudinal, prospective and interventional clinical Study with 2 years of duration (CORDIS).
Who can participate
Age range35 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Informed consent.
* Diabetes Mellitus type 2 according to 1985 WHO criteria.
* Age between 35 and 85 years.
At least in one eye:
Mild or moderate DR, with NPDR levels 20, 35, 43 and 47 (based on the ETDRS criteria - 7 fields CFP);
* Absence of CIME or PDR;
* Presence of at least 1 MA in the central 6000 µm in diameter area - Field 2;
* No previous intravitreal injections;
* BCVA 75 letters (20 /32);
* Refraction with a spherical equivalent less than 5 Dp.
At 6 months (Visit 2), at least one of the following criteria should be met:
Phenotype B criteria:
\- OCT RT above the following thresholds (DRCR.net criteria)(16,29)
For ETDRS levels 20, 35, 43 and 47 at least 1 of the following criteria should be met at month 6:
Central RT (within centre circle 1000 µm in diameter area) above abnormal gender-specific thickness assessed based on OCT (DRCR.net criteria). Defined, considering Cirrus SD-OCT, the following thresholds (2):
* Central RT between 260 and 290 µm for women (SCME) and between 275 and 305 µm for men (SCME)
* Central RT greater than 290 µm for women (CIME) and Central RT greater than 305 µm for men (CIME).
OR
Phenotype C criteria:
\- MA Turnover ≥ 6, assessed by RetmarkerDR. OR Patients who do not meet the eligibility criteria in visit 2 for phenotype B or C but that were previously identified as phenotype B or C will also be considered as eligible by investigator decision.
Exclusion Criteria
* Cataract or other eye disease that may interfere with fundus…
What they're measuring
1
Development of CIME or PDR
Timeframe: 24 months
2
Capillary closure in the superficial and deep retinal vascular layers
Timeframe: 24 months
3
LOR ratios
Timeframe: 24 months
Trial details
NCT IDNCT03696810
SponsorAssociation for Innovation and Biomedical Research on Light and Image