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出境医 / 临床实验 / WF and PR OCTA in Diabetic Retinopathy
WF and PR OCTA in Diabetic Retinopathy
Study Description
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 |
Study Design
| 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 2023 |
| Estimated Study Completion Date : | December 2023 |
Arms and Interventions
| Group/Cohort |
|---|
|
Group A: PDR
This group will consist of 25 subjects with active proliferative diabetic retinopathy (PDR) and 25 subjects with treated PDR.
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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.
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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.
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Group C: DM without Retinopathy
This group will consist of 50 subjects with diabetes mellitus (DM) who do not have retinopathy.
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Group D: Healthy Controls
This group will consist of 40 subjects with healthy eyes who do not have diabetes.
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Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Denzil Romfh, OD | 503-494-4351 | romfhd@ohsu.edu | |
| Contact: George Pacheco, COA | 503-494-7398 | pachecge@ohsu.edu |
Locations
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Denzil Romfh, OD 503-494-4351 romfhd@ohsu.edu | |
| Contact: George Pacheco, COA 503-494-7398 pachecge@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
| Principal Investigator: | Thomas Hwang, MD | 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 |
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| 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 |
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| 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 |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
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)
Participant-Related Exclusion Criteria: I. Group B
Eye-Related Inclusion Criteria: I. Group A:
II. Group B:
III. Groups C & D:
IV. Group ME:
Eye-Related Exclusion Criteria: (Applies to study eye only. May be present in non-study eye.)
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| 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 |
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| 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 |
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| PRS Account | Oregon Health and Science University | ||||||||
| Verification Date | September 2020 | ||||||||
