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

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ClinicalTrials.gov Identifier: NCT01440660
Recruitment Status : Completed
First Posted : September 26, 2011
Last Update Posted : October 8, 2015
Sponsor:
Collaborator:
University of Coimbra
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image

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

Condition or disease
Type-2 Diabetes Diabetic Retinopathy

Study Type : Observational
Actual Enrollment : 20 participants
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).
Study Start Date : January 2012
Primary Completion Date : September 2014
Study Completion Date : September 2014


Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 26, 2011    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases