OCT Angiography in Wet AMD

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

Official title:

Optical Coherence Tomography Angiography in Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02253030
• Other study ID #: IRB#000010535
• Status: Recruiting
• Start date: September 2014
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Oregon Health and Science University
• Contact: George Pacheco, COA
• Phone: 503-494-7398
• Email: pachecge[@]ohsu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Optical Coherence Tomography

Locations

Country	Name	City	State
United States	Casey Eye Institute, Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of choroidal neovascular (CNV) vessel area in mm2		1 year
Primary	Measure of CNV membrane area in mm2		1 year
Primary	Measure of CNV length density in mm		1 year
Primary	Measure of retinal fluid volume in mm3		1 year
Primary	Measure of drusen area in mm2		3 years