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.
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
- Conditions the study is for
- Neovascular Age-related Macular Degeneration, Age-related Macular Degeneration, Diabetic Retinopathy
- What is being tested?
- AngioVue SD-OCT
- Type of treatment
- Injection or infusion, Medical device
- 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.
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.
- Conditions
- Neovascular Age-related Macular Degeneration, Age-related Macular Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion, Diabetic Macular Edema
- 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 group | Role | What they receive |
|---|---|---|
| SD-OCT Angiography | Experimental | 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. Receives: Device: AngioVue SD-OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted29 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion11 Mar 2019
- Study completion11 Mar 2019
Why it stopped: Terminated due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Optovue
- Responsible party
- Sponsor
- Investigators
- Priyatham Mettu, MD, Principal investigator, Duke University
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Domain-Optical Coherence Tomography Angiography of Retinal Diseases
- ClinicalTrials.gov ID
- NCT02510885
- Acronym / sponsor ID
- Pro00063777
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to COVID-19
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Optovue
- Study start
- Jul 2015
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Posted 19 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SD-OCT Angiography | Experimental | Device: AngioVue SD-OCTStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable or unwilling to give consent
- Under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngioVue SD-OCTOCT-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. | Device | SD-OCT Angiography |
Primary outcome
Number of Participants With Image Quality Sensitive Enough to Identify Specific New Vessel Morphology
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priyatham Mettu, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
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.