Phenotypes of Nonproliferative Diabetic Retinopathy in DM 2 Patients Identified by OCT, CFP, RLA and mfERG (DIAMARKER)
NCT ID: NCT01440660
Last Updated: 2015-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2012-01-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Leaking Phenotype
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.
No interventions assigned to this group
Ischemic Phenotype
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Diabetes mellitus type 2 according to 1985 WHO criteria.
3. Non-proliferative diabetic retinopathy (ETDRS level \<= 35)
4. Signs of NPDR progression based on existing clinical information:
1. 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
2. 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).
5. Informed consent.
Exclusion Criteria
2. Any eye surgery or treatment within a period of 6-months.
3. Pregnant or nursing (lactating) women.
4. Patients with chronic or severe kidney disease (glomerular filtration rate, GFR \< 30 mL/min/1.73m2).
5. Patients with acute kidney injury.
6. Patients with known allergic or hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients.
7. Patients around the time of liver transplantation..
8. Patients with implants containing metals.
18 Years
ALL
No
Sponsors
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University of Coimbra
OTHER
Association for Innovation and Biomedical Research on Light and Image
OTHER
Responsible Party
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Principal Investigators
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José Cunha-Vaz, MD PhD
Role: STUDY_CHAIR
Association for Innovation and Biomedical Research on Light and Image
Miguel Castelo-Branco, MD PhD
Role: STUDY_CHAIR
FMUC
Luísa Ribeiro, MD MSc
Role: PRINCIPAL_INVESTIGATOR
AIBILI - CEC
Locations
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AIBILI - Clinical Trials Centre (CEC)
Coimbra, , Portugal
Countries
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Other Identifiers
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4C-2011-01
Identifier Type: -
Identifier Source: org_study_id
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