OCT Angiography in Wet AMD
Study Details
Study Description
Brief Summary
The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to:
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diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD)
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evaluate patients undergoing treatment for wet AMD
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determine if reduced flow to the choroid is a risk factor for developing wet AMD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Newly-diagnosed, untreated wet AMD This group will be adults newly diagnosed with wet AMD who have not undergone any treatment for the condition. Their data will be gathered only once, prior to treatment. |
Device: Optical Coherence Tomography
|
| Wet AMD undergoing "as-needed" treatment This group will be adults undergoing treatment as-needed for wet AMD. They will be followed monthly over the course of 1 year. |
Device: Optical Coherence Tomography
|
| High-risk eyes This group will be adults with wet AMD in one eye and findings of dry AMD in the other. The eye with dry AMD will be followed every 6 months for 3 years. |
Device: Optical Coherence Tomography
|
| Wet AMD undergoing a "treat and extend" strategy This group will be adults with wet AMD undergoing treatment under the "treat and extend" strategy. (The "treat and extend" strategy increases the intervals between treatments as long as the macula remains dry.) They will be followed over the course of 1 year with extra imaging before extending follow-up intervals. |
Device: Optical Coherence Tomography
|
Outcome Measures
Primary Outcome Measures
- Measure of choroidal neovascular (CNV) vessel area in mm2 [1 year]
- Measure of CNV membrane area in mm2 [1 year]
- Measure of CNV length density in mm [1 year]
- Measure of retinal fluid volume in mm3 [1 year]
- Measure of drusen area in mm2 [3 years]
Eligibility Criteria
Criteria
Inclusion Criteria (Groups with wet AMD):
- Adults aged 50 and older with clinical findings of treatment-naïve (never treated) neovascular AMD with active new blood vessel growth confirmed by clinical testing will be considered
Inclusion Criteria (Group with healthy eyes)
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No evidence of retinal disease
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Refractive error greater than +3.00 diopters or -7.00 diopters (glasses Rx)
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No recent eye surgery in the last 4 months
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No significant cataract to interfere with the quality of the imaging
Exclusion Criteria (All Groups):
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Inability to give informed consent
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Significant kidney disease
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Blood pressure greater than 180/110
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Previous macular laser treatment
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Inability to maintain stable fixation during OCT imaging
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Visual acuity worse than 20/200
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Casey Eye Institute, Oregon Health & Science University | Portland | Oregon | United States | 97239 |
Sponsors and Collaborators
- Oregon Health and Science University
Investigators
- Principal Investigator: Steven Bailey, MD, Oregon Health and Science University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB#000010535