Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
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: January 29, 2015
Last verified: January 2015

September 22, 2011
January 29, 2015
January 2012
September 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01440660 on ClinicalTrials.gov Archive Site
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).
Same as current
Not Provided
Not Provided
 
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).

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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).

  • Type-2 Diabetes
  • Diabetic Retinopathy
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT01440660
4C-2011-01
No
Association for Innovation and Biomedical Research on Light and Image
Association for Innovation and Biomedical Research on Light and Image
University of Coimbra
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
Association for Innovation and Biomedical Research on Light and Image
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP