Diabetes PRP and OCT
Completed
Conditions studied: Proliferative Diabetic Retinopathy
In brief
The purpose of this study is to evaluate the effectiveness of investigational Doppler Optical Coherence Tomography (OCT) and OCT angiography in the management of proliferative diabetic retinopathy (PDR - a leading cause of blindness in diabetic patients) before and after treatment. Angiography is the mapping of the blood vessels, and Doppler detects blood flow. PDR is due to poor oxygen circulation in smaller blood vessels in the back of the eye (retina), and is observed in 80% of people who have had diabetes for more than 10 years. This study will look at how blood flow to the eye is affected before and after treatment.
Key facts
- Study ID
- NCT01928550
- Run by
- Oregon Health and Science University
- People needed
- 8
- Starts
- 2013-08-01
- Expected to finish
- 2016-05-25
- Last updated by the study team
- 2018-04-09
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- a. Diagnosis of diabetes mellitus (type 1 or type 2).
You may not qualify if…
- Inability to give informed consent.
- Inability to maintain stable fixation for OCT imaging.
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
- Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to treatment
- Women who are pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography
- Subject is expecting to move out of the area of the clinical center to an area and not willing to return for follow-up visits during the 6 months of the study.
Where it is running
- Oregon Health & Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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