IRB #

IRB00010949

Title

Functional Optical Coherence Tomography-Derived Biomarkers for Diabetic Retinopathy

Principal Investigator

Thomas Hwang

Study Purpose

Recently, we have used a high-speed OCT system to make non-invasive functional measurements such as angiography, total retinal blood flow, and retinal arterial pulsatility. The goal of the proposed project is to improve these functional OCT-derived
biomarkers and determine their roles in the early detection and management of diabetic retinopathy.

Medical Condition(s)

1. Non-Proliferative Diabetic Retinopathy (NPDR)
2. Proliferative Diabetic Retinopathy (PDR)

Eligibility Criteria

Inclusion Criteria for Diabetic Subjects (Groups A and B):
- Adults 18 and older
- Type I diabetics of greater than 5 years duration OR Type II diabetics of any duration

Inclusion Criteria for Diabetic Study Eyes (Groups A and B). One eye must meet all criteria:
- Group A1: PDR with presence of active active retinal neovascularization (RNV) within field 1 or 2 on fundus photos, confirmed with fluorescein angiography (FA)
- Group A2: Severe NPDR confirmed on 7-field fundus photos using the International Clinical Retinopathy Severity Scales OR PDR with active RNV outside fields 1 or 2.
- Group B1: Mild or moderate NPDR, confirmed on 7-field fundus photos using the International Clinical Diabetic Retinopathy Severity Scales
Group B2: Diabetes without evidence of retinopathy, confirmed on 7-field fundus photos

Inclusion Criteria for Study Eye for Control Subjects (Group C):
- No evidence of diabetic retinopathy on exam, confirmed by 7-field fundus photos
- No evidence of retinal vascular disease
- No evidence of retinal macular disease
- Ability to maintain stable fixation for OCT imaging
- No recent ocular surgery within 4 months
- Visual acuity 20/200 or better
- No substantial cataract estimated by physician to interfere with quality scans

Exclusion Criteria for All Subjects (Groups A, B and C):
- Inability to give informed consent
- Significant renal disease, defined as 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 (ie, unstable medical status including blood pressure greater than 180/110 or unstable cardiovascular disease)

Exclusion Criteria for Study Eyes (Groups A, B and C). May be present in non-study eye:
- Presence of another ocular disease, including retinal vein occlusions, reetinal arterial occlusions, macular telangiectasis, radiation retinopathy, uveitis, or any other retinal vascular disease that may alter retinal perfusion or permeability in the opinion of the investigator
- Presence of another ocular disease, including epiretinal membrane, macular hole, retinal detachment and other conditions that may alter the retinal anatomy in the opinion of the investigator
- Inability to mantain stable fixation for OCT imaging
- Visual acuity worse than 20/200
- Substantial media opacity, including significant cataract, corneal scar, vitreous hemorrhage, that in the opinion of the investigator is likely to interfere with acquisition of study imaging
- History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc) within prior 4 months

Age Range

18 - 100

Healthy Volunteers Needed

Yes

Duration of Participation

Diabetics: One year with total of 2 study visits (Initial and 12-month)
Controls: One study visit only

Minors Included

No

Contact

Denny Romfh
503-494-4351
romfhd@ohsu.edu

Sponsor

National Institutes of Health, National Eye Institute

Recruitment End

12/31/2017

Compensation Provided

Yes

Compensation

Diabetics: $40 for each successfully completed visit (ie, $80 total compensation per subject if both study visits completed)
Controls: $40 for successful completion of enrollment visit


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