Status:
COMPLETED
Phenotypes of Nonproliferative Diabetic Retinopathy in DM 2 Patients Identified by OCT, CFP, RLA and mfERG (DIAMARKER)
Lead Sponsor:
Association for Innovation and Biomedical Research on Light and Image
Collaborating Sponsors:
University of Coimbra
Conditions:
Type-2 Diabetes
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Brief Summary
To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression using multimodal testing/imaging procedures.
Eligibility Criteria
Inclusion
- Age over 18 years-old.
- Diabetes mellitus type 2 according to 1985 WHO criteria.
- Non-proliferative diabetic retinopathy (ETDRS level \<= 35)
- Signs of NPDR progression based on existing clinical information:
- Retinal thickness (RT) increase (increase in RT above normal range as measured by OCT, considering the macular thickness normative data) in the central subfield, the inner ring and/or the outer ring (leaking phenotype); OR
- Neovascular disease activity as shown by microaneurysms (MA) turnover (MA formation rate \>= 2, i.e. number of new MA per year) computed from CFP using the RetmarkerDR software (ischemic phenotype).
- Informed consent.
Exclusion
- Cataract or other eye disease that may interfere with fundus examinations
- Any eye surgery or treatment within a period of 6-months.
- Pregnant or nursing (lactating) women.
- Patients with chronic or severe kidney disease (glomerular filtration rate, GFR \< 30 mL/min/1.73m2).
- Patients with acute kidney injury.
- Patients with known allergic or hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients.
- Patients around the time of liver transplantation..
- Patients with implants containing metals.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01440660
Start Date
January 1 2012
End Date
September 1 2014
Last Update
October 8 2015
Active Locations (1)
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1
AIBILI - Clinical Trials Centre (CEC)
Coimbra, Portugal, 3000-548