Pilot Study of OCT Versus Fluorescein Angiography in DME

NCT01876914 | Completed

• 2 other identifiers: OHSU IRB #93618UL1TR000128-07
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Macular Edema

Keywords

Diabetes; Edema; DME; OCT

Outcome Measures

Primary Outcomes (1)

• Total retinal blood flow & visual acuity

  Total retinal blood flow, as measured by Doppler OCT, is correlated with visual acuity and the area of macular ischemia as evaluated by FA. This will be performed by the following analysis: 1. Pearson's correlation test of total retinal blood flow with logMAR visual acuity; 2. Pearson's correlation test of total retinal blood flow with the area of macular ischemia on FA.

  1 year

Secondary Outcomes (2)

• Macular ischemic areas and microaneurysms, as identified by FA vs. OCT

  1 year

• The degree of parafoveal ischemia as identified by OCT and visual acuity

  1 year

Study Arms (1)

DME patients

Patients suspected to have a problem with at least one eye called diabetic macular edema or DME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals 18 years of age and older presenting to the Retina Service within the Department of Ophthalmology at the Casey Eye Institute of Oregon Health \& Science University with signs and symptoms of DME will be evaluated for enrollment into this study. This pilot study has a planned enrollment target sample size of 28 subjects with DME. However, up to 35 subjects will be recruited as it is possible that after subjects sign the consent form they may not meet all eligibility criteria.

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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Oregon Clinical and Translational Research Institute: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Edema

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Lauer, M.D.

  Oregon Health & Science Universtiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Andreas Lauer, MD: Associate Professor of Ophthalmology, Retina Division Chief

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 13, 2013
• Study Start: June 1, 2013
• Primary Completion: December 23, 2017
• Study Completion: December 23, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

US (1)