OCT Angiography in Wet AMD

Oregon Health & Science University (OHSU)

Status: Enrolling

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

Treatments: Device: Optical Coherence Tomography

Study type: Observational

Funder types: Other

Identifiers

NCT02253030

IRB#000010535

Details and patient eligibility

About

The primary goals of this study are to use optical coherence tomography (OCT) angiography (blood vessel mapping) to:

1. diagnose the presence of new blood vessels in wet age-related macular degeneration (AMD)
2. evaluate patients undergoing treatment for wet AMD
3. determine if reduced flow to the choroid is a risk factor for developing wet AMD.

Enrollment: 160 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

• 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

Trial design

160 participants in 4 patient groups

Newly-diagnosed, untreated wet AMD

Description:

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.

Treatment:

Device: Optical Coherence Tomography

Wet AMD undergoing "as-needed" treatment

Description:

This group will be adults undergoing treatment as-needed for wet AMD. They will be followed monthly over the course of 1 year.

Treatment:

Device: Optical Coherence Tomography

High-risk eyes

Description:

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.

Treatment:

Device: Optical Coherence Tomography

Wet AMD undergoing a "treat and extend" strategy

Description:

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.

Treatment:

Device: Optical Coherence Tomography