Recruiting

OCT Angiography

Sponsor:

Oregon Health and Science University

Code:

NCT02253030

Conditions

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

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Optical Coherence Tomography

Study Details

Brief 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.

Conditions

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

Study ID

NCT02253030

Start date

Sep, 2014

Status verified date

Feb, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

Optical Coherence Tomography

Primary outcome measure

  • Measure of choroidal neovascular (CNV) vessel area in mm2 [ Time Frame: 1 year ]
  • Measure of CNV membrane area in mm2 [ Time Frame: 1 year ]
  • Measure of CNV length density in mm [ Time Frame: 1 year ]
  • Measure of retinal fluid volume in mm3 [ Time Frame: 1 year ]
  • Measure of drusen area in mm2 [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

George Pacheco, COA

503-494-7398pachecge@ohsu.edu

Denny Romfh, OD

503-494-4351romfhd@ohsu.edu

Locations

Casey Eye Institute, Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

George Pacheco, COA

503-494-7398pachecge@ohsu.edu

Denny Romfh, OD

503-494-4351romfhd@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Feb 12, 2024

Last verified

Feb, 2024

Keywords

  • AMD
  • OCT
  • Angiography
  • Macular degeneration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-02-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.