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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Coimbra
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT01440660
First received: September 22, 2011
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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


Condition
Type-2 Diabetes
Diabetic Retinopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Association for Innovation and Biomedical Research on Light and Image:

Primary Outcome Measures:
  • Multimodal testing/imaging procedures - Ophthalmological Imaging [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Retinal thickness measured with OCT;

  • Multimodal testing/imaging procedures - Ophthalmological Imaging [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    MA turnover computed based on CFP.

  • Multimodal testing/imaging procedures - Ophthalmological Imaging [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Macular area with increased retinal fluorescein leakage based on RLA.

  • Multimodal testing/imaging procedures - Ophthalmological Imaging [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Implicit time local and ring amplitudes measured with mfERG.

  • Multimodal testing/imaging procedures - Psychophysical Testing [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Psychophysical tests for speed discrimination, achromatic contrast, and chromatic contrast.

  • Multimodal testing/imaging procedures - Barin Imaging [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Perfusion change measured with ASL.

  • Multimodal testing/imaging procedures - Ophthalmological Imaging [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Blood-Brain Barrier alterations assessed contrast agent with Dynamic MR.

  • Multimodal testing/imaging procedures - Brain Imaging [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Metabolite concentrations assessed with MR Spectroscopy.


Secondary Outcome Measures:
  • Multimodal testing/ imaging modalities (raw data) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Raw data obtained from the different modalities (OCT,MA turnover, RLA,mfERG, psychophysical tests, ASL, Dynamic MR and MR Spectroscopy).


Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of 20 patients, male and female over 18 years-old, with type-2 diabetes mellitus and NPDR with signs of DR progression (RT increase and/or MA turnover) (according to the inclusion/exclusion criteria).

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440660

Locations
Portugal
AIBILI - Clinical Trials Centre (CEC)
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
University of Coimbra
Investigators
Study Chair: José Cunha-Vaz, MD PhD Association for Innovation and Biomedical Research on Light and Image
Study Chair: Miguel Castelo-Branco, MD PhD FMUC
Principal Investigator: Luísa Ribeiro, MD MSc AIBILI - CEC
  More Information

No publications provided

Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT01440660     History of Changes
Other Study ID Numbers: 4C-2011-01
Study First Received: September 22, 2011
Last Updated: October 25, 2012
Health Authority: Portugal: Health Ethic Committee

Additional relevant MeSH terms:
Diabetic Retinopathy
Diabetes Mellitus
Diabetes Mellitus, Type 2
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
 Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013