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OCT Biomarkers for Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT02330042
Recruitment Status : Recruiting
First Posted : January 1, 2015
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Tracking Information
First Submitted Date December 30, 2014
First Posted Date January 1, 2015
Last Update Posted Date April 9, 2020
Study Start Date September 2014
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2020)
  • Number of participants with decreased total retinal blood flow by OCT angiography [ Time Frame: 1 year ]
    Total retinal blood flow will be measured in uL/min.
  • Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography [ Time Frame: 1 year ]
    Neovascular membrane area will be measured in mm2.
  • Number of participants with measureable macular edema by OCT imaging [ Time Frame: 1 year ]
    Retinal thickening area will be measured in mm2.
Original Primary Outcome Measures
 (submitted: December 30, 2014)
  • Number of participants with decreased total retinal blood flow by OCT angiography [ Time Frame: 1 year ]
  • Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography [ Time Frame: 1 year ]
  • Number of participants with measureable macular edema by OCT imaging [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title OCT Biomarkers for Diabetic Retinopathy
Official Title Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy
Brief Summary Diabetic retinopathy (DR) is caused by changes in the blood vessels of the retina associated with long-term Type 1 or Type 2 diabetes mellitus. DR is a leading cause of blindness in the United States. Standard optical coherence tomography (OCT) cannot directly detect vascular changes, which may occur early affecting the passage of blood through the tiny capillaries (reduced capillary flow) or cause the greatest damage through formation of abnormal blood vessel growth (neovascularization). Currently, fluorescein angiography (FA) is the gold standard for detecting these changes, but FA requires an injection of a dye into the vein of the arm of the patient. This dye can cause undesirable side effects. Recently, OCT has been used to make functional measurements (such as total retinal blood flow among others) and to perform angiography. Thus, functional OCT may provide a useful, alternate way to evaluate diabetic retinopathy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with Type 1 diabetes of greater than 5 years duration OR Type 2 diabetes of any duration. Healthy controls are also being enrolled in this study.
Condition Diabetic Retinopathy
Intervention Not Provided
Study Groups/Cohorts
  • Group A

    Patients with:

    • Type 1 or Type 2 diabetes mellitus
    • severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR).
  • Group B

    Patients with:

    • Type 1 or Type 2 diabetes mellitus
    • with or without mild to moderate NPDR
  • Group C (controls)
    Patients without diabetes or evidence of any form of eye disease
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 30, 2014)
215
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria for participants with diabetes:

  • Male or female participants 18-79 years old
  • With Type 1 diabetes for over 5 years or Type 2 diabetes of any duration

Exclusion Criteria for participants with diabetes:

  • Vision worse than 20/200
  • Inability to maintain fixation for OCT imaging
  • Significant kidney disease, kidney failure or kidney transplant
  • Unstable medical status, including blood pressure greater than 180/110 or unstable heart disease
  • Pregnant or nursing an infant
  • Presence of an eye disease (other than diabetic retinopathy) that can affect retinal blood flow, retinal permeability or retinal anatomy
  • Significant cataract, corneal scar, vitreous bleed or other media opacity
  • History of major eye surgery within 4 months prior to enrollment in this study

Inclusion Criteria for participants without diabetes (controls):

  • Male or female participants 18-79 years old

Exclusion Criteria for participants without diabetes (controls):

  • Vision worse than 20/200
  • Inability to maintain fixation for OCT imaging
  • Significant kidney disease, kidney failure or kidney transplant
  • Unstable medical status, including blood pressure greater than 180/110 or unstable heart disease
  • Pregnant or nursing an infant
  • Presence of any eye disease that can affect retinal blood flow, retinal permeability or retinal anatomy
  • Significant cataract, corneal scar, vitreous bleed or other media opacity
  • History of major eye surgery within 4 months prior to enrollment in this study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: David Poole, COT 503-494-8024 pooleb@ohsu.edu
Contact: Denzil Romfh, OD 503-494-4351 romfhd@ohsu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02330042
Other Study ID Numbers IRB#00010949
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party David Huang, Oregon Health and Science University
Study Sponsor Oregon Health and Science University
Collaborators Not Provided
Investigators
Principal Investigator: Thomas Hwang, MD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date April 2020