Diabetic Retinopathy and Subclinical Signs of Disease Transition

NCT03635671 | Terminated

• 1 other identifier: DIRECTION
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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. Some factors are known to temporarily aggravate or improve diabetic retinopathy, but underlying pathophysiologic factors are still unknown. High-resolution imaging techniques of the retina and its supplying vascular networks now allow novel insight to subtle changes that cannot be appreciated in standard fundus examination. In detail, the investigators image study patients with optical coherence tomography (OCT) - technology, that provides morphological information of retinal structure and the supplying vessels in a non-invasive way. Retinal layer thickness as well as capillary density will be quantified and followed in patients that are in a critical period of disease transition to better understand the process of diabetic retinopathy.

Conditions

Diabetic Retinopathy

Keywords

Imaging; Diabetes; OCTA

Outcome Measures

Primary Outcomes (1)

• Perfusion density

  Mean change of perfusion density of the macula evaluated within the 9 ETDRS subfields for the superior and inferior vascular plexus separately.

  6 months

Secondary Outcomes (2)

• Perfusion density

  12 months

• Retinal layer thickness

  6 and 12 months

Study Arms (2)

Intensified blood glucose control

Patients with diabetes mellitus type 2 and poor blood sugar control that are introduced to insulin or GLP-1 therapy

Diagnostic Test: Optical Coherence Tomography Angiography

Nephropathy

Patients that are introduced to hemodialysis or renal transplantation secondary to renal failure

Diagnostic Test: Optical Coherence Tomography Angiography

Interventions

Optical Coherence Tomography Angiography DIAGNOSTIC_TEST

Retinal scans will be acquired at each follow up visit

Also known as: Optical Coherence Tomography

Intensified blood glucose control; Nephropathy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diabetes type 1 or 2 that enter a critical period of possible disease transition will be recruited in a tertiary referral center.

You may qualify if:

• Diabetes mellitus type 1 or 2
• Age 18-90

You may not qualify if:

• Media opacities like cataract or vitreous hemorrhage
• 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
• Atrophy of retinal pigment epithelium, subretinal fibrosis, laser scar within foveal avascular zone (FAZ) or organized hard exudate plaques
• Ocular disorders 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 photographs or fluorescein angiograms of sufficient quality to be analyzed and graded

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Eye Care Center

Vancouver, British Columbia, V5Z 3N9, Canada

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• David Maberley, MD

  Head of the Department of Ophthalmology and Visual Science, UBC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCSC

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: September 1, 2018
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)