Diabetes PRP and OCT

NCT01928550 | Completed

• 2 other identifiers: IRB000095728UL1TR000128-07
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Proliferative Diabetic Retinopathy

Keywords

Diabetes; OCT; PDR

Outcome Measures

Primary Outcomes (1)

• Total retinal blood flow & visual acuity

  1\) Total retinal blood flow, as measured by Doppler OCT, will be correlated with visual acuity and the severity of PDR. This will be performed by the following analysis: 1. Pearson's correlation test of total retinal blood flow with logMAR (Logarithm of the Minimal Angle of Resolution) visual acuity before and after PRP; 2. Pearson's correlation test of total retinal blood flow with area of capillary drop-out on FA before and after PRP; 3. Pearson's correlation test of total retinal blood flow with areas of leakage on FA before and after PRP; 4. Pearson's correlation test of total retinal blood flow with areas of thickening on OCT before and after PRP. 5. Paired t test of total retinal blood flow on OCT before and after PRP.

  1 year

Secondary Outcomes (1)

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

  1 year

Study Arms (1)

PDR patients

Patients suspected to have Proliferative Diabetic Retinopathy or PDR

Eligibility Criteria

• Age: 18 Years - 100 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 PDR will be considered and evaluated for enrollment into this study. This pilot study has a planned enrollment target sample size of 28 subjects needing PRP. However, up to 40 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:

• 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.

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

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Christina Flaxel, MD

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: August 26, 2013
• Study Start: August 1, 2013
• Primary Completion: May 25, 2016
• Study Completion: May 25, 2016
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

US (1)