Diabetes MellitusNCT03765112
Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT
A study testing Optical coherence tomography angiography in people with Diabetes Mellitus and Diabetic Retinopathy, run by University of British Columbia at 1 site in Canada.
Trial summary
This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy
- What is being tested?
- Optical coherence tomography angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2018to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 Participants can have 1 or 2 study eyes
- Patient Group:
- Diabetes mellitus type 1 or 2
- Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR
Who cannot join
- Substantial media opacities that would preclude successful imaging
- Active intraocular inflammation (grade trace or above) in either eye like infectious conjunctivitis, keratitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis in either eye
- Structural damage to the center of macula in the study eye
- History of prior panretinal photocoagulation
- History of treatment with intravitreal agents over the prior 6 months
- Macular edema involving the central subfield
Show all 12Show fewer
- Prior history of vitrectomy
- Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques
- Substantial non-diabetic intraocular pathology in the study eye including retinal vascular occlusion, retinal detachment, macular hole, choroidal neovascularization, macula dystrophies
- Intraocular surgery (including cataract surgery, YAG laser capsulotomy) in the study eye within 3 months preceding Day 0, or history of corneal transplantation in the study eye
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication)or history of glaucoma filtration surgery
- Inability to obtain fundus images of sufficient quality to be analyzed and graded
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Eye Care Center
Vancouver, V5Z 3N9
Eduardo Navajas, MD, 604 875 5475, edunavajas@gmail.com
Theresa Wiens, MSc, 604-875-4111 ext. 62544, twiens@eyecarecentre.org
About this study
This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls.
Read the detailed description
The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the most prevalent complication of DM and a leading cause of visual impairment due to closure of capillaries. High-resolution imaging techniques of the retina and its supplying vascular networks can allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In this study capillary changes of patients with different severity levels of diabetic retinopathy will be investigated with non-invasive imaging technology to better understand the process of disease progression.
Imaging will be done with Optical Coherence tomography (OCT) angiography as well as spectral domain OCT and ultra wide-field imaging.
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy
- Being tested
- Optical coherence tomography angiography
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiographyDevice
Multiple scans of the retina will be recorded to evaluate microvascular changes.
| Study group | Role | What they receive |
|---|---|---|
| OCTA | Experimental | Patients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging. Receives: Device: Optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion density
The density of perfused capillaries (metric variable) measured with optical coherence tomography angiography (OCTA) will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Measured: 6 months
Secondary outcomes (6)
Areas of different perfusion density
Perfusion density of the capillary network will be measured at seven different areas and will be compared within the same patient
Measured: 6 months
Foveal avascular zone (FAZ)
Size (area) of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Measured: 6 months
Foveal avascular zone (FAZ)
The circularity of FAZ will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
Measured: 6 months
Presence of predominantly peripheral lesions (PPL)
The presence of PPL (categorical variable yes/no) will be correlated with the perfusion density measured with OCTA
Measured: 6 months
Retinal layer thickness
Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA
Measured: 6 months
Change in perfusion density in patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR over the follow up of one year
Patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR will be followed over one year. Perfusion density will be measured at each timepoint and followed over the year,
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start20 Sep 2018
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Navajas, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765112
- Sponsor's protocol ID
- H18-02095
- Status last verified
- Sep 2021
- First submitted
- 28 Nov 2018
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karst SG, Heisler M, Lo J, Schuck N, Safari A, V Sarunic M, Maberley DAL, Navajas EV. Evaluating Signs of Microangiopathy Secondary to Diabetes in Different Areas of the Retina with Swept Source OCTA. Invest Ophthalmol Vis Sci. 2020 May 11;61(5):8. doi: 10.1167/iovs.61.5.8.
PubMed 32392316
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT
- ClinicalTrials.gov ID
- NCT03765112
- Acronym / sponsor ID
- H18-02095
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls.
Detailed description
The prevalence of diabetes mellitus (DM) is increasing worldwide. Diabetic retinopathy is the most prevalent complication of DM and a leading cause of visual impairment due to closure of capillaries. High-resolution imaging techniques of the retina and its supplying vascular networks can allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In this study capillary changes of patients with different severity levels of diabetic retinopathy will be investigated with non-invasive imaging technology to better understand the process of disease progression.
Imaging will be done with Optical Coherence tomography (OCT) angiography as well as spectral domain OCT and ultra wide-field imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCTA | Experimental | Device: Optical coherence tomography angiographyPatients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 Participants can have 1 or 2 study eyes
- Diabetes mellitus type 1 or 2
- Study eye with any DR severity level: no DR, mild NPDR, mod NPDR, sev NPDR, PDR
Key exclusion criteria (12 listed)
- Substantial media opacities that would preclude successful imaging
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 |
|---|---|---|
| Optical coherence tomography angiographyMultiple scans of the retina will be recorded to evaluate microvascular changes. | Device | OCTA |
Primary outcome
Perfusion density
Time frame: 6 months
The density of perfused capillaries (metric variable) measured with optical coherence tomography angiography (OCTA) will be compared between the different severity levels of diabetic retinopathy as well as to the control arm.
6 secondary outcomes
Areas of different perfusion density
Time frame: 6 months
Foveal avascular zone (FAZ)
Time frame: 6 months
Foveal avascular zone (FAZ)
Time frame: 6 months
Presence of predominantly peripheral lesions (PPL)
Time frame: 6 months
Retinal layer thickness
Time frame: 6 months
Change in perfusion density in patients with moderate or severe non proliferative diabetic retinopathy (DR) or low risk proliferative DR over the follow up of one year
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Derived from this study: PubMed 32392316Karst SG, Heisler M, Lo J, Schuck N, Safari A, V Sarunic M, Maberley DAL, Navajas EV. Evaluating Signs of Microangiopathy Secondary to Diabetes in Different Areas of the Retina with Swept Source OCTA. Invest Ophthalmol Vis Sci. 2020 May 11;61(5):8. doi: 10.1167/iovs.61.5.8.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical coherence tomography angiography in people with Diabetes Mellitus and Diabetic Retinopathy, run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 1 Oct 2021. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eduardo Navajas, MD (604 875 5475, edunavajas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion density (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765112, which also lists 1 linked publication.
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 1 Oct 2021.