Pilot Study of OCT Versus Fluorescein Angiography in DME

Completed

Conditions studied: Diabetic Macular Edema

In brief

Diabetic Macular Edema (DME), which can happen as a complication of diabetes, occurs when fluid and proteins collect in the macula (the yellow central area of the retina). The fluid can cause swelling which in turn can lead to worsening central vision. The purpose of this study is to see if the study device (Swept Source Optical Coherence Tomography or SS-OCT) is able to diagnose DME as well as an already approved imaging procedure called fluorescein angiography (FA). FA is standard of care and would be conducted regardless of study participation. The dye used in FA, which can cause allergic reactions in some patients and is not used in pregnant women, is not needed with the study device. Another purpose of the study is to avoid the risk of administering the FA dye if possible.

Key facts

Study ID

NCT01876914

Run by

Oregon Health and Science University

People needed

20

Starts

2013-06-01

Expected to finish

2017-12-23

Last updated by the study team

2018-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of diabetes mellitus (type 1 or type 2).

You may not qualify if…

• Inability to give informed consent.
• Inability to complete study tests within a 30 day period.
• 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 prior history of reaction to fluorescein or other dyes.
• 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 of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography.

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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