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OpenTrials
Completed

NCT Number: NCT01440660

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

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

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Key information

Conditions

Type-2 Diabetes Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AIBILI - Clinical Trials Centre (CEC)

Coimbra, 3000-548, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Multimodal testing/imaging procedures - Ophthalmological Imaging

    Time frame: 24 months

    Retinal thickness measured with OCT;

  2. Multimodal testing/imaging procedures - Ophthalmological Imaging

    Time frame: 24 months

    MA turnover computed based on CFP.

  3. Multimodal testing/imaging procedures - Ophthalmological Imaging

    Time frame: 12 months

    Macular area with increased retinal fluorescein leakage based on RLA.

  4. Multimodal testing/imaging procedures - Ophthalmological Imaging

    Time frame: 12 months

    Implicit time local and ring amplitudes measured with mfERG.

  5. Multimodal testing/imaging procedures - Psychophysical Testing

    Time frame: 12 months

    Psychophysical tests for speed discrimination, achromatic contrast, and chromatic contrast.

  6. Multimodal testing/imaging procedures - Barin Imaging

    Time frame: 12 months

    Perfusion change measured with ASL.

  7. Multimodal testing/imaging procedures - Ophthalmological Imaging

    Time frame: 12 months

    Blood-Brain Barrier alterations assessed contrast agent with Dynamic MR.

  8. Multimodal testing/imaging procedures - Brain Imaging

    Time frame: 12 months

    Metabolite concentrations assessed with MR Spectroscopy.

Secondary outcomes

  1. Multimodal testing/ imaging modalities (raw data)

    Time frame: 24 months

    Raw data obtained from the different modalities (OCT,MA turnover, RLA,mfERG, psychophysical tests, ASL, Dynamic MR and MR Spectroscopy).

Sponsors and collaborators

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image

Other

Collaborators

  • University of Coimbra

Registry information

Official study title

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).

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2011
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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