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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 12, 2018
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

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.

Condition or disease
Diabetic Retinopathy

Study Type : Observational
Estimated Enrollment : 215 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy
Study Start Date : September 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Number of participants with decreased total retinal blood flow by OCT angiography [ Time Frame: 1 year ]
  2. Number of participants with capillary dropout and/or new abnormal retinal blood vessel growth by OCT angiography [ Time Frame: 1 year ]
  3. Number of participants with measureable macular edema by OCT imaging [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

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): NCT02330042


Contacts
Contact: David Poole, COT 503-494-8024 pooleb@ohsu.edu
Contact: Denzil Romfh, OD 503-494-4351 romfhd@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: David Poole, COT    503-494-8024    pooleb@ohsu.edu   
Contact: Denzil Romfh, OD    503-494-4351    romfhd@ohsu.edu   
Principal Investigator: Thomas Hwang, MD         
Sub-Investigator: Andreas Lauer, MD         
Sub-Investigator: Christina Flaxel, MD         
Sub-Investigator: Steve Bailey, MD         
Sub-Investigator: Michael Klein, MD         
Sub-Investigator: Phoebe Lin, MD         
Sub-Investigator: David Wilson, MD         
Sub-Investigator: Yali Jia, PhD         
Sub-Investigator: Ou Tan, PhD         
Sub-Investigator: Lorinna Lombardi, MD         
Sub-Investigator: Ellen Davis, MD         
Sub-Investigator: Seema Gupta, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Thomas Hwang, MD Oregon Health and Science University

Responsible Party: David Huang, Yali Jia, PhD, Research Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02330042     History of Changes
Other Study ID Numbers: IRB#00010949
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Keywords provided by David Huang, Oregon Health and Science University:
Diabetes
OCT
Angiography
Diabetic retinopathy

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