WF and PR OCTA in Diabetic Retinopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03922932|
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : September 16, 2020
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||290 participants|
|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|
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.
- 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.
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
|Contact: Denzil Romfh, ODfirstname.lastname@example.org|
|Contact: George Pacheco, COAemail@example.com|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Denzil Romfh, OD 503-494-4351 firstname.lastname@example.org|
|Contact: George Pacheco, COA 503-494-7398 email@example.com|
|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|
|Principal Investigator:||Thomas Hwang, MD||Oregon Health and Science University|