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Recruiting NCT02253030

OCT Angiography in Wet AMD

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optical Coherence Tomography.
Who it may be relevant to
Registry conditions: Neovascular (Wet) Age-related Macular Degeneration (AMD). Basic parameters: 50 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Optical Coherence Tomography Angiography in Neovascular Age-related Macular Degeneration

Overview

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.

Interventions

  • Device Optical Coherence Tomography

Primary outcome measures

  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Casey Eye Institute, Oregon Health & Science University — Portland

Identifiers

NCT: NCT02253030 · IRB#000010535

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗