- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03635671
Diabetic Retinopathy and Subclinical Signs of Disease Transition (DIRECTION)
August 27, 2019 updated by: David Maberley, University of British Columbia
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 3N9
- Eye Care Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- Diabetes mellitus type 1 or 2
- Age 18-90
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intensified blood glucose control
Patients with diabetes mellitus type 2 and poor blood sugar control that are introduced to insulin or GLP-1 therapy
|
Retinal scans will be acquired at each follow up visit
Other Names:
|
Nephropathy
Patients that are introduced to hemodialysis or renal transplantation secondary to renal failure
|
Retinal scans will be acquired at each follow up visit
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perfusion density
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perfusion density
Time Frame: 12 months
|
Mean change of perfusion density of the macula evaluated within the 9 ETDRS subfields for the superior and inferior vascular plexus separately.
|
12 months
|
Retinal layer thickness
Time Frame: 6 and 12 months
|
Mean change in retinal layer thickness of all retinal layers separately
|
6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Maberley, MD, Head of the Department of Ophthalmology and Visual Science, UBC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
July 15, 2019
Study Completion (Actual)
July 15, 2019
Study Registration Dates
First Submitted
August 15, 2018
First Submitted That Met QC Criteria
August 15, 2018
First Posted (Actual)
August 17, 2018
Study Record Updates
Last Update Posted (Actual)
August 29, 2019
Last Update Submitted That Met QC Criteria
August 27, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIRECTION
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
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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