OCT Angiography in Wet AMD

Study Overview
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Brief Summary
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The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to: diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD) evaluate patients undergoing treatment for wet AMD determine if reduced flow to the choroid is a risk factor for developing wet AMD.

Official Title
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Optical Coherence Tomography Angiography in Neovascular Age-related Macular Degeneration

Conditions
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Neovascular (Wet) Age-related Macular Degeneration (AMD)

Intervention / Treatment
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* Device: Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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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) No evidence of retinal disease Refractive error greater than +3.00 diopters or -7.00 diopters (glasses Rx) No recent eye surgery in the last 4 months No significant cataract to interfere with the quality of the imaging Exclusion Criteria (All Groups): Inability to give informed consent Significant kidney disease Blood pressure greater than 180/110 Previous macular laser treatment Inability to maintain stable fixation during OCT imaging Visual acuity worse than 20/200

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newly-diagnosed, untreated wet AMD<br>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<br> <br> |
| Wet AMD undergoing as-needed treatment<br>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<br> <br> |
| High-risk eyes<br>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<br> <br> |
| Wet AMD undergoing a treat and extend strategy<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, OCT, Macular degeneration, Angiography