NCT02253030

Brief Summary

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

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Sep 2014Dec 2026

Study Start

First participant enrolled

September 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
12.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

12.3 years

First QC Date

September 25, 2014

Last Update Submit

February 8, 2024

Conditions

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

Keywords

AMDOCTAngiographyMacular degeneration

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (4)

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

Interventions

Optical Coherence TomographyDEVICE
High-risk eyesNewly-diagnosed, untreated wet AMDWet AMD undergoing "as-needed" treatmentWet AMD undergoing a "treat and extend" strategy

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Casey Eye Institute, Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Steven Bailey, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

George Pacheco, COA

CONTACT

503-494-7398pachecge@ohsu.edu

Denny Romfh, OD

CONTACT

503-494-4351romfhd@ohsu.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Steven Bailey, MD, Assistant Professor of Ophthalmology

Study Record Dates

First Submitted

September 25, 2014

First Posted

October 1, 2014

Study Start

September 1, 2014

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations

US(1)