Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diabetic Retinopathy and Subclinical Signs of Disease Transition (DIRECTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03635671
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
David Maberley, University of British Columbia

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.

Condition or disease Intervention/treatment
Diabetic Retinopathy Diagnostic Test: Optical Coherence Tomography Angiography

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diabetic Retinopathy and Subclinical Signs of Disease Transition
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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
Diagnostic Test: Optical Coherence Tomography Angiography
Retinal scans will be acquired at each follow up visit
Other Name: Optical Coherence Tomography

Nephropathy
Patients that are introduced to hemodialysis or renal transplantation secondary to renal failure
Diagnostic Test: Optical Coherence Tomography Angiography
Retinal scans will be acquired at each follow up visit
Other Name: Optical Coherence Tomography




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Retinal layer thickness [ Time Frame: 6 and 12 months ]
    Mean change in retinal layer thickness of all retinal layers separately



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635671


Contacts
Layout table for location contacts
Contact: Sonja Karst, MD 604-875-5475 sonja.karst@ubc.ca
Contact: Theresa Wiens 604-875-4111 ext 62544 twiens@eyecarecentre.org

Locations
Layout table for location information
Canada, British Columbia
Eye Care Center Recruiting
Vancouver, British Columbia, Canada, V5Z 3N9
Contact: Theresa Wiens, MSc    604-875-4111 ext 62544    twiens@eyecarecentre.org   
Sub-Investigator: Sonja Karst, MD         
Sponsors and Collaborators
University of British Columbia
Investigators
Layout table for investigator information
Principal Investigator: David Maberley, MD Head of the Department of Ophthalmology and Visual Science, UBC

Layout table for additonal information
Responsible Party: David Maberley, MD, FRCSC, University of British Columbia
ClinicalTrials.gov Identifier: NCT03635671     History of Changes
Other Study ID Numbers: DIRECTION
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David Maberley, University of British Columbia:
Imaging
Diabetes
OCTA

Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases