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WF and PR OCTA in Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT03922932
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Brief Summary:
Diabetic retinopathy (DR) is a leading cause of vision loss in working-age Americans. Capillary damage from hyperglycemia causes vision loss through downstream effects, such as retinal ischemia, edema, and neovascularization (NV). Proper screening and timely treatment with laser photocoagulation and anti-vascular endothelial growth factor (VEGF) injections can minimize morbidity. In the last decade, clinicians have been able to use objective structural data from optical coherence tomography (OCT) to guide the treatment of diabetic macular edema. Other aspects of care, however, still largely depend on subjective interpretation of clinical features and fluorescein angiography (FA) to determine the disease severity and treatment threshold. The recently developed OCT angiography (OCTA) provides dye-less, injection-free, three-dimensional images of the retinal and choroidal circulation with high capillary contrast. Not only is it safer, faster, and less expensive than conventional dye-based angiography, OCTA provides the potential of giving clinicians objective tools for determining severity of disease by detecting and quantifying NV and non-perfusion.

Condition or disease
Diabetic Retinopathy

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Study Type : Observational
Estimated Enrollment : 290 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Wide-Field and Projection-Resolved Optical Coherence Tomography Angiography in Diabetic Retinopathy
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Group A: PDR
This group will consist of 25 subjects with active proliferative diabetic retinopathy (PDR) and 25 subjects with treated PDR.
Group B: NPDR
This group will consist of 50 subjects with severe non-proliferative diabetic retinopathy (NPDR), 50 subjects with moderate NPDR, and 50 subjects with mild NPDR.
Group ME: Macular Edema
This group is a sub-set of 25 subjects from either Group A or B who have macular edema requiring treatment.
Group C: DM without Retinopathy
This group will consist of 50 subjects with diabetes mellitus (DM) who do not have retinopathy.
Group D: Healthy Controls
This group will consist of 40 subjects with healthy eyes who do not have diabetes.



Primary Outcome Measures :
  1. PR-OCTA Measure of Non-Perfusion Areas [ Time Frame: 3 years ]
    Non-perfusion areas of the 3 retinal plexuses and choriocapillaris will be measured in mm2.

  2. Non-PR-OCTA Measure of Retinal Non-Perfusion Areas [ Time Frame: 1 year ]
    Non-perfusion areas of the 3 retinal plexuses will be measured in mm2.

  3. Non-PR-OCTA Retinal Neovascularization Areas [ Time Frame: 1 year ]
    Retinal neovascularization areas will be measured in mm2.

  4. Structural OCT Cyst Volume [ Time Frame: 1 year ]
    Cyst volume will be measured in mm3.

  5. Structural OCT Retinal Thickening Area [ Time Frame: 1 year ]
    The area of retinal thickening will be measured in mm2.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults age 18 or older with either healthy eyes or diabetic retinopathy
Criteria

Participant-Related Inclusion Criteria:

I. All Diabetics (Groups A, B, C)

  • Type 1 diabetes of at least 5 years duration or
  • Type 2 diabetes of any duration II. Group B
  • Able to return for follow-up over 3 years

Participant-Related Exclusion Criteria:

I. Group B

  • Significant medical condition that would make long-term follow-up difficult II. Controls (Group D)
  • Any medical problems associated with retinal vascular abnormalities (i.e., hypertension, systemic vasculitis, carotid insufficiency, etc.)

Eye-Related Inclusion Criteria:

I. Group A:

  • Presence of active neovascularization, with or without prior treatment
  • Presence of involuted fibrovascular proliferans

II. Group B:

  • NPDR of any severity as defined by the International Clinical Diabetic Retinopathy Severity Scale

III. Groups C & D:

  • No evidence of diabetic retinopathy

IV. Group ME:

  • Presence of center-involving macular edema requiring treatment

Eye-Related Exclusion Criteria: (Applies to study eye only. May be present in non-study eye.)

  • Visual acuity worse than 20/200
  • Inability to maintain stable fixation for OCT imaging
  • History of major eye surgery (vitrectomy, cataract surgery, scleral buckle, other intraocular surgery, etc.) within 90 days of enrollment
  • History of another eye disease or condition that may alter retinal perfusion, permeability, or retinal anatomy
  • Substantial media opacity (cataract, corneal scar, vitreous hemorrhage) that may interfere with study imaging

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): NCT03922932


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

Locations
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United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: David Poole, COT    503-494-8024    pooleb@ohsu.edu   
Contact: Denny Romfh, OD    503-494-4351    romfhd@ohsu.edu   
Sub-Investigator: David Wilson, MD         
Sub-Investigator: Andreas Lauer, MD         
Sub-Investigator: Steve Bailey, MD         
Sub-Investigator: Phoebe Lin, MD, PhD         
Sub-Investigator: John P Campbell, MD, PhD         
Sub-Investigator: Christina Flaxel, MD         
Sub-Investigator: Kavita Bhavsar, MD         
Sub-Investigator: Matthew Duggan, MD         
Sub-Investigator: Rene Choi, MD, PhD         
Sub-Investigator: Stanford Taylor, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Thomas Hwang, MD Oregon Health and Science University

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Responsible Party: David Huang, Thomas Hwang, MD, Associate Professor of Ophthalmology, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03922932     History of Changes
Other Study ID Numbers: OHSU IRB#00016932
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

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