OCT Angiography in Wet AMD

NCT ID: NCT02253030

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Optical Coherence Tomography

Intervention Type DEVICE

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.

Optical Coherence Tomography

Intervention Type DEVICE

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.

Optical Coherence Tomography

Intervention Type DEVICE

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.

Optical Coherence Tomography

Intervention Type DEVICE

Interventions

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Optical Coherence Tomography

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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David Huang

Steven Bailey, MD, Assistant Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Steven Bailey, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Casey Eye Institute, Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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George Pacheco, COA

Role: CONTACT

503-494-7398

Denny Romfh, OD

Role: CONTACT

503-494-4351

Facility Contacts

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George Pacheco, COA

Role: primary

503-494-7398

Denny Romfh, OD

Role: backup

503-494-4351

Other Identifiers

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IRB#000010535

Identifier Type: -

Identifier Source: org_study_id

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