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Neovascular Age-related Macular DegenerationNCT02510885

SD-OCT Angiography

A study testing AngioVue SD-OCT in people with Neovascular Age-related Macular Degeneration and Age-related Macular Degeneration, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective of this study is to image retinal vascular alterations in patients with retinal disease using the AngioVue OCT-A system and understand the information these images provide. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AngioVue SD-OCT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteUnited States
Study dates
Jul 2015to 11 Mar 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable and willing to provide consent
  • History of clinically diagnosed retinal diseases, including but not limited to age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, macular telangiectasias, and diabetic macular edema
  • At least 18 years of age

Who cannot join

  • Unable or unwilling to give consent
  • Under 18 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke Eye Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Spectral Domain-Optical Coherence Tomography Angiography of Retinal Diseases

The objective of this study is to image retinal vascular alterations in patients with retinal disease using the AngioVue OCT-A system and understand the information these images provide. The investigators will image study participants who have retinal diseases with the AngioVue unit (Optovue) and will collect relevant clinical data to understand the nature of the information contained in images obtained on AngioVue. This study being conducted under an abbreviated IDE. The investigators will analyze data using descriptive statistics. Risks related to light exposure will be managed by ensuring that the exposure to the AngioVue light source is well below maximum permissible limits for safe exposure.

Read the detailed description

OCT is an optical ranging and imaging technique first described in 1991 that has since been used successfully to provide high-resolution, micrometer-scale depth imaging in clinical ophthalmology (and other fields). It can be thought of as the optical analogue of ultrasound imaging. For the ocular posterior segment, OCT provides rapid acquisition of high-resolution, cross-sectional images of the retina that approximate tissue histology. In vivo imaging of the retina with OCT has thus dramatically improved clinicians' diagnostic capabilities, allowing earlier and more accurate diagnosis of disease and more precise assessment of response to therapies over time.

While OCT provides important information on retinal anatomy, it is currently limited in its ability to provide information on retinal vasculature and blood flow. Angiography is the current gold-standard imaging modality for retinal vascular imaging. Angiography involves intravenous injection of a fluorescent dye (typically either fluorescein or indocyanine green for the retinal or choroidal vessels, respectively) that circulates through the body. A light source emitting light at the specific excitation wavelength of the dye is placed in front of the patient's eye, and a camera equipped with a filter corresponding to the emission wavelength of the dye is then used to image vessel morphology and retinal perfusion, either through still images or through a short movie. Angiography provides physiologic information about the retina that complements the anatomical information provided by OCT. While generally well tolerated by most patients, angiography does have drawbacks: it often requires the use of a separate imaging system, it requires several minutes for image acquisition, and it involves intravenous injection of a dye. Patients occasionally experience side effects of intravenous dye administration, including nausea, discomfort, and rarely, anaphylaxis.

Several retinal imaging companies are developing the next generation of OCT technology: OCT angiography (OCT-A). OCT-A allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid (the vascular plexus subjacent to the retina), without the need for intravenous dye administration. OCT-A platforms currently under development include both spectral domain (SD) and swept-source (SS) based technologies. Whereas SS-based OCT-A utilizes a longer wavelength (~1060 nm) light source, SD-based units use the same light source used in commercially available and FDA-cleared OCT units on a modified platform. Optovue, Inc. (Fremont, CA) has developed one such unit, a customized, high-resolution SD-OCT system that implements a novel algorithm, the amplitude-based method of split-spectrum amplitude-decorrelation angiography (SSADA) for OCT-A. This SSADA algorithm allows for detection of motion in the blood vessel lumen by measuring the variation in reflected OCT signal amplitude between consecutive cross-sectional scans. Optovue has integrated the novel SSADA algorithm into their commercially approved RTVue SD-OCT unit for their OCT-A unit, the AngioVue. The AngioVue can generate high-quality angiograms of both the retina and choroid. Additionally, this refined method has produced images of the smallest retinal vessels (capillaries) in normal healthy control participants. In this proposed prospective interactive clinical study, we will use the AngioVue unit to image patients and characterize vascular abnormalities that are present in the setting of retinal diseases.

Being tested
AngioVue SD-OCT
Keywords
neovascular age-related macular degeneration, age-related macular degeneration, diabetic retinopathy, SD-OCT, Angiography, diabetic macular edema
Medical subject headings
Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AngioVue SD-OCTDevice

    OCT-A allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid, without intravenous dye administration. SD-OCT units use the light source used in commercially available and FDA-cleared OCT units on a modified platform. Optovue, Inc. has developed a customized SD-OCT system that implements a novel algorithm, the amplitude-based method of split-spectrum amplitude-decorrelation angiography (SSADA) for OCT-A. This detects motion in the blood vessel lumen by measuring the variation in reflected OCT signal amplitude between consecutive cross-sectional scans. Optovue has integrated the novel SSADA algorithm into their commercially approved RTVue SD-OCT unit for their OCT-A unit, the AngioVue. This unit is being conducted under an abbreviated IDE.

Study groups in NCT02510885
Study groupRoleWhat they receive
SD-OCT AngiographyExperimentalStudy participants will undergo imaging of both eyes with the AngioVue unit (approximately 60 seconds/eye), per standard operating protocol. Imaging is noncontact, and pharmacologic dilation will not be used for the purposes of this study. In most instances, study participants will undergo only a single imaging session on a single day. However, potential participants will be asked to consent for additional imaging sessions (up to 12) that may occur over the course of subsequent future visits to the clinic. Additionally, study participants will be asked to consent to prospective collection of clinical and demographic data, to correlate findings of OCT-A imaging to subsequent clinical course.
Receives: Device: AngioVue SD-OCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Image Quality Sensitive Enough to Identify Specific New Vessel Morphology

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion11 Mar 2019
  4. Study completion11 Mar 2019

Why it stopped: Terminated due to COVID-19

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02510885
Sponsor's protocol ID
Pro00063777
Status last verified
Mar 2022
First submitted
28 Jul 2015
Last updated
19 Apr 2022
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing AngioVue SD-OCT in people with Neovascular Age-related Macular Degeneration and Age-related Macular Degeneration, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Image Quality Sensitive Enough to Identify Specific New Vessel Morphology (time frame: Day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.

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