Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT

This study evaluates micro-vascular changes in patients with diabetes. Results of diseased retinas will be compared to healthy controls.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus; Diabetic Retinopathy
• Intervention / Treatment: Device: Optical coherence tomography angiography

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 Type: Interventional
• Enrollment (Anticipated): 175
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eduardo Navajas, MD; Phone Number: 604 875 5475; Email: edunavajas@gmail.com
• Study Contact Backup: Name: Theresa Wiens; Phone Number: 62544 604-875-4111; Email: twiens@eyecarecentre.org

Study Locations

• Canada
  • Vancouver, Canada, V5Z 3N9
    • Recruiting
    • Eye Care Center
    • Contact: Eduardo Navajas, MD; Phone Number: 604 875 5475; Email: edunavajas@gmail.com
    • Contact: Theresa Wiens, MSc; Phone Number: 62544 604-875-4111; Email: twiens@eyecarecentre.org
    • Sub-Investigator: Sonja Karst, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
  • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCTA; Patients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging.	Device: Optical coherence tomography angiography; Multiple scans of the retina will be recorded to evaluate microvascular changes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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	6 months
Retinal layer thickness	Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA	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,	18 months

Collaborators and Investigators

• Sponsor: University of British Columbia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2018
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: H18-02095

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No