Diabetic Retinopathy and Subclinical Signs of Disease Transition

Diabetic Retinopathy Clinical Trial

— DIRECTION  

Official title:

Diabetic Retinopathy and Subclinical Signs of Disease Transition

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03635671
• Other study ID #: DIRECTION
• Status: Terminated
• Start date: September 1, 2018
• Est. completion date: July 15, 2019

Study information

• Verified date: August 2019
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	Eye Care Center	Vancouver	British Columbia

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	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	Perfusion density	Mean change of perfusion density of the macula evaluated within the 9 ETDRS subfields for the superior and inferior vascular plexus separately.	12 months
Secondary	Retinal layer thickness	Mean change in retinal layer thickness of all retinal layers separately	6 and 12 months