Phenotypes of Nonproliferative Diabetic Retinopathy in DM 2 Patients Identified by OCT, CFP, RLA and mfERG (DIAMARKER)

Phenotypes of Nonproliferative Diabetic Retinopathy in Diabetes Type 2 Patients Identified by Optical Coherence Tomography, Colour Fundus Photography, Fluorescein Leakage and Multifocal Electrophysiology (DIAMARKER Project: Genetic Susceptibility for Multi-systemic Complications in Diabetes Type-2: New Biomarkers for Diagnostic and Therapeutic Monitoring).

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01440660

Enrollment

Registered

2011-09-26

Start date

2012-01-31

Completion date

2014-09-30

Last updated

2015-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy, Type-2 Diabetes

Brief summary

To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression using multimodal testing/imaging procedures.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age over 18 years-old. 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

1. Cataract or other eye disease that may interfere with fundus examinations 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.

Design outcomes

Primary

Measure	Time frame	Description
Multimodal testing/imaging procedures - Ophthalmological Imaging	24 months	Retinal thickness measured with OCT;
Multimodal testing/imaging procedures - Psychophysical Testing	12 months	Psychophysical tests for speed discrimination, achromatic contrast, and chromatic contrast.
Multimodal testing/imaging procedures - Barin Imaging	12 months	Perfusion change measured with ASL.
Multimodal testing/imaging procedures - Brain Imaging	12 months	Metabolite concentrations assessed with MR Spectroscopy.

Secondary

Measure	Time frame	Description
Multimodal testing/ imaging modalities (raw data)	24 months	Raw data obtained from the different modalities (OCT,MA turnover, RLA,mfERG, psychophysical tests, ASL, Dynamic MR and MR Spectroscopy).

Countries

Portugal

Outcome results