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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 141
- Locations
- 2
- Primary Endpoint
- LOR ratios
Study Overview
Brief 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).
Detailed Description
Diabetic Retinopathy (DR) is a frequent complication of Diabetes Mellitus (DM) and is the main cause of vision loss in the working population in western countries.
Several studies provided evidence that good diabetic control is important to prevent and delay disease progression, but while some patients develop sight-threatening DR (STDR) despite good control, others escape the development of vison loss with poor metabolic control.
The STDR is defined as DME and PDR. DME is defined as thickening of the macula and is mainly due to accumulation of fluid in the central macular area resulting mainly from fluid leakage due to the alterations of the BRB. Identifying the eyes/patients at risk to develop central involved macular edema (CIME) and consequent vision-loss, as well as to understand its causes is fundamental for its appropriate treatment and, finally, to avoid vision loss due to DME.
Several studies have shown different prevalence's of DR, ranging from 10.1% to 48.1%.
The prevalence of DM in Portugal has increased and, between patients aged 20 to 79 years, was 11.7% in 2009, reaching 13.3% in 2013.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
- •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 examinations.
- •Glaucoma.
- •Any eye surgery within a period of 6-months before the screening visit date.
- •Other retinal vascular disease.
- •Previous laser or intravitreal injection treatment.
- •Dilatation of the pupil < 5 mm.
Outcomes
Primary Outcomes
LOR ratios
Time Frame: 24 months
LOR ratios obtained with OCT-L analysis in the full retina and layer by layer.
Development of CIME or PDR
Time Frame: 24 months
Characterization of retinal microvascular changes occurring in eyes with mild to moderate NPDR
Capillary closure in the superficial and deep retinal vascular layers
Time Frame: 24 months
Capillary closure in the superficial and deep retinal vascular layers by vessel density calculation, quantified by OCTA software (Angioplex, Zeiss);
Secondary Outcomes
- Microaneurysms turnover(24 months)
- Retinal Thickness(24 months)