OHSU

IRB #

IRB00010535

Title

Optical coherence tomography angiography in neovascular age-related macular degeneration

Principal Investigator

Steven Bailey

Study Purpose

To improve optical coherence tomography (OCT) blood vessel mapping technology in the eye and determine its role in age-related macular degeneration (AMD) evaluation and management.

Medical Condition(s)

Neovascular (wet) macular degeneration
Non-exudative (dry) macular degeneration

Eligibility Criteria

Inclusion for AMD subjects:

Arms 1 & 2
- Adults age 50 and older
- clinical findings of treatment naive neovascular AMD with active choroidal neovascularization (CNV), confirmed by dye leakage on fluorescein angiogram
- At least one of the following on OCT: subretinal fluid (SRF), intraretinal fluid (IRF) or subretinal pigment epithelial fluid.

Arm 3
- Adults age 50 and older
- Drusen in study eye
- Pigmentary changes in study eye
- History of CNV in fellow eye

Inclusion for healthy controls:
- No evidence of retinal macular disease – including drusen, epiretinal membrane, or macular edema
- No evidence of retinal vascular disease: hypertensive retinopathy, diabetic retinopathy, or retinal vein occlusion
- Refractive error within the following range +3.00 diopters to – 7.00 diopters (prior to cataract surgery if applicable)
- No recent ocular surgery within 4 months
- No substantial cataract estimated by physician to interfere with quality scans

Exculsion for all subjects:
- Inability to give informed consent
- 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.
- Prior macular laser treatment or photodynamic therapy (PDT)
- Inability to maintain stable fixation for OCT
- Visual acuity worse than 20/200
- Fibrosis > 75% of the CNV lesion
- Other ocular condition is present such that, in the opinion of the investigator, may alter the retinal anatomy (e.g., epiretinal membrane)
- An ocular condition is present (other than neovascular AMD) that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis, or other ocular inflammatory disease, etc.)
- Substantial cataract that, in the opinion of the investigator, is likely to interfere with imaging with FA, color photos, fundus autofluorescence (FAF), and OCT
- Media opacity or other that would prevent either fixation or ability to obtain adequate images as determined by the examiner
- History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months

Additional exclusion for longitudinal studies:
- Inability to commit to one year of follow-up due to a life threatening or debilitating illness making it unlikely the subject could complete the study, limited transportation, or refusal to provide informed consent or of commitment to the full length of the study

Age Range

50 - 100

Healthy Volunteers Needed

Yes

Duration of Participation

Arm 1: one visit
Arm 2: one year
Arm 3: three years

Minors Included

No

Contact

Shahrzad Mohammadi
503-494-7398
mohammas@ohsu.edu

Sponsor

National Institute of Health, National Eye Institute

Recruitment End

Compensation Provided

Yes

Compensation

Initial visit $30
Follow-up visits $20


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