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Characterization of Retinal Vascular Disease in Eyes With Mild to Moderate NPDR in Diabetes Type 2 (CORDIS)

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ClinicalTrials.gov Identifier: NCT03696810
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Fundação para a Ciência e a Tecnologia
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image

Brief Summary:
Characterization of Retinal vascular disease in eyes with mild to moderate NPDR in Diabetes type 2, using novel non-invasive Imaging methods, in a longitudinal, prospective and interventional clinical Study with 2 years of duration (CORDIS).

Condition or disease Intervention/treatment Phase
NPDR - Non Proliferative Diabetic Retinopathy Diagnostic Test: Laboratory tests Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Characterization of Retinal Vascular Disease in Eyes With Mild to Moderate NPDR in Diabetes Type 2, Using Novel Non-invasive Imaging Methods, in a Longitudinal, Prospective and Interventional Clinical Study With 2 Years of Duration (CORDIS)
Actual Study Start Date : October 30, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 17, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
• Laboratory tests
• Laboratory tests (HbA1C levels and lipids)
Diagnostic Test: Laboratory tests
• Laboratory tests (HbA1C levels and lipids)




Primary Outcome Measures :
  1. Development of CIME or PDR [ Time Frame: 24 months ]
    Characterization of retinal microvascular changes occurring in eyes with mild to moderate NPDR

  2. Capillary closure in the superficial and deep retinal vascular layers [ Time Frame: 24 months ]
    Capillary closure in the superficial and deep retinal vascular layers by vessel density calculation, quantified by OCTA software (Angioplex, Zeiss);

  3. LOR ratios [ Time Frame: 24 months ]
    LOR ratios obtained with OCT-L analysis in the full retina and layer by layer.


Secondary Outcome Measures :
  1. Microaneurysms turnover [ Time Frame: 24 months ]
    Microaneurysms turnover computed from CFP using the RetmarkerDR software

  2. Retinal Thickness [ Time Frame: 24 months ]
    RT obtained with structural OCT in the full retina and by retinal layers



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Diabetes Mellitus type 2 according to 1985 WHO criteria
  • Age between 35 and 80 years
  • HbA1c ≤ 10 %
  • Mild or moderate DR, with NPDR levels 20, 35, 43 and 47 (based on the ETDRS criteria - 7 fields CFP)
  • Absence of CIME or PDR
  • Presence of at least 1 MA in the central 6000 µm in diameter area
  • No previous intravitreal injections
  • BCVA 75 letters (20 /32)
  • Refraction with a spherical equivalent less than 5 Dp
  • Central RT (within centre circle 1000 µm in diameter area) above abnormal gender-specific thickness assessed based on OCT
  • Central RT between 260 and 290 µm for women (SCME) and between 275 and 305 µm for men (SCME)
  • Central RT greater than 290 µm for women (CIME) and Central RT greater than 305 µm for men (CIME).
  • MA Turnover ≥ 6, assessed by RetmarkerDR.

Exclusion Criteria:

  • Cataract or other eye disease that may interfere with fundus examinations.
  • Glaucoma.
  • Any eye surgery within a period of 6-months before the screening visit date.
  • Other retinal vascular disease.
  • Previous laser or intravitreal injection treatment.
  • Dilatation of the pupil < 5 mm.

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): NCT03696810


Contacts
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Contact: Maria L Ribeiro, PhD +351 239 480 124 lr@aibili.pt
Contact: Liliana C Soares, BSc +351239480151 lcarvalho@aibili.pt

Locations
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Portugal
AIBILI- Association for Biomedical Research and Inovation on Light and Image. Recruiting
Coimbra, Portugal, 3000-548
Contact: Maria L Ribeiro, PhD    00351239480124    lr@aibili.pt   
Contact: Liliana C Soares, BSc    00351239480151    lcarvalho@aibili.pt   
Principal Investigator: Maria L Ribeiro, PhD         
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
Fundação para a Ciência e a Tecnologia

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Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT03696810     History of Changes
Other Study ID Numbers: CEC/194/18
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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