CClinicalTrials.gg
TerminatedNCT02510885Updated Apr 19, 2022Results posted

SD-OCT Angiography

An interventional study of AngioVue SD-OCT in Neovascular Age-related Macular Degeneration, Age-related Macular Degeneration and Diabetic Retinopathy, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-19.

Sponsored by Duke University · Not applicable, Interventional, and Other

Why this study was terminated
Terminated due to COVID-19
Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Neovascular Age-related Macular Degeneration
  • Age-related Macular Degeneration
  • Diabetic Retinopathy
  • Retinal Vein Occlusion
  • Diabetic Macular Edema

Keywords

  • neovascular age-related macular degeneration
  • age-related macular degeneration
  • diabetic retinopathy
  • SD-OCT
  • Angiography
  • diabetic macular edema
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 39 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Unable or unwilling to give consent
  • Under 18 years of age
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (actual)

Study arms

  • Experimental
    SD-OCT Angiography

    Study 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.

    Device: AngioVue SD-OCT

Interventions

  • DeviceAngioVue SD-OCT

    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.

06

What researchers measure

Primary outcomes

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

    Time frame: Day 0

07

Results

Posted Apr 19, 2022

Participant flow

Participant flow — Overall Study
MilestoneSD-OCT Angiography
Started39
Completed39
Not completed0

Outcome measures

PrimaryNumber of Participants With Image Quality Sensitive Enough to Identify Specific New Vessel Morphology
Time frame:
Day 0
Reported as:
Count of participants · Participants
Number of Participants With Image Quality Sensitive Enough to Identify Specific New Vessel Morphology
ParticipantsSD-OCT Angiography
Number of Participants With Image Quality Sensitive Enough to Identify Specific New Vessel Morphology39

Adverse events

Collected over Day 0. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SD-OCT Angiography0/39 (0%)0/39 (0%)0/39 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)SD-OCT Angiography
Mean64.4 ± 19.5
Sex: Female, Male
Sex: Female, Male(Participants)SD-OCT Angiography
Female20
Male19
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SD-OCT Angiography
Hispanic or Latino1
Not Hispanic or Latino38
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)SD-OCT Angiography
United States39
08

Study locations

1 site
  • Duke Eye Center
    Durham, North Carolina 27710, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · May 18, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02510885
Lead sponsor
Duke University
Collaborators
Optovue
Responsible party
Sponsor
First posted
Jul 29, 2015
Start date
Jul 2015
Primary completion
Mar 11, 2019
Completion
Mar 11, 2019
Results posted
Apr 19, 2022
Last update
Apr 19, 2022

Study contacts

Priyatham Mettu, MD
principal investigator · Duke University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion