Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT

Diabetes Mellitus Clinical Trial

Official title:

Macular Involvement in Diabetic Retinopathy Evaluated With Swept-Source OCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03765112
• Other study ID #: H18-02095
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2021
• Source: University of British Columbia
• Contact: Eduardo Navajas, MD
• Phone: 604 875 5475
• Email: edunavajas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: March 31, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Retinal Diseases

Intervention

Device:
• Optical coherence tomography angiography
Multiple scans of the retina will be recorded to evaluate microvascular changes.

Locations

Country	Name	City	State
Canada	Eye Care Center	Vancouver

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Retinal layer thickness	Retinal layer thickness measured with optical coherence tomography (OCT) will be correlated with the perfusion density measured with OCTA	6 months
Secondary	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