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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 : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

Tracking Information
First Submitted Date April 18, 2019
First Posted Date April 22, 2019
Last Update Posted Date September 16, 2020
Actual Study Start Date August 30, 2017
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2019)
  • 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.
  • 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.
  • Non-PR-OCTA Retinal Neovascularization Areas [ Time Frame: 1 year ]
    Retinal neovascularization areas will be measured in mm2.
  • Structural OCT Cyst Volume [ Time Frame: 1 year ]
    Cyst volume will be measured in mm3.
  • Structural OCT Retinal Thickening Area [ Time Frame: 1 year ]
    The area of retinal thickening will be measured in mm2.
Original Primary Outcome Measures Same as current
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 WF and PR OCTA in Diabetic Retinopathy
Official Title Wide-Field and Projection-Resolved Optical Coherence Tomography Angiography in Diabetic Retinopathy
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.
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 Non-Probability Sample
Study Population Adults age 18 or older with either healthy eyes or diabetic retinopathy
Condition Diabetic Retinopathy
Intervention Not Provided
Study Groups/Cohorts
  • 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.
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: April 18, 2019)
290
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Denzil Romfh, OD 503-494-4351 romfhd@ohsu.edu
Contact: George Pacheco, COA 503-494-7398 pachecge@ohsu.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03922932
Other Study ID Numbers OHSU IRB#00016932
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
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 September 2020