OCT Angiography in Wet AMD

Optical Coherence Tomography Angiography in Neovascular Age-related Macular Degeneration

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.

Study Overview

• Status: Recruiting
• Conditions: Neovascular (Wet) Age-related Macular Degeneration (AMD)
• Intervention / Treatment: Device: Optical Coherence Tomography

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: George Pacheco, COA; Phone Number: 503-494-7398; Email: pachecge@ohsu.edu
• Study Contact Backup: Name: Denny Romfh, OD; Phone Number: 503-494-4351; Email: romfhd@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Casey Eye Institute, Oregon Health & Science University
      • Sub-Investigator: Andreas Lauer, MD
      • Sub-Investigator: Christina Flaxel, MD
      • Sub-Investigator: Michael Klein, MD
      • Contact: George Pacheco, COA; Phone Number: 503-494-7398; Email: pachecge@ohsu.edu
      • Sub-Investigator: Thomas Hwang, MD
      • Sub-Investigator: Phoebe Lin, MD, PhD
      • Sub-Investigator: Kavita Bhavsar, MD
      • Sub-Investigator: John Campbell, MD, PhD
      • Sub-Investigator: Yali Jia, PhD
      • Sub-Investigator: Ou Tan, PhD
      • Contact: Denny Romfh, OD; Phone Number: 503-494-4351; Email: romfhd@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Both female and male participants over the age of 50 are being studied.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Steven Bailey, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimated): October 1, 2014

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: OCT; AMD; Macular degeneration; Angiography
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: IRB#000010535