NCT03765112

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

3.8 years

First QC Date

November 28, 2018

Last Update Submit

September 29, 2021

Conditions

Diabetes MellitusDiabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Areas of different perfusion density

    6 months

  • Foveal avascular zone (FAZ)

    6 months

  • Foveal avascular zone (FAZ)

    6 months

  • Presence of predominantly peripheral lesions (PPL)

    6 months

  • Retinal layer thickness

    6 months

  • +1 more secondary outcomes

Study Arms (1)

OCTA

EXPERIMENTAL

Patients with diabetes and healthy controls will be imaged with optical coherence tomography (OCT) angiography, Spectral domain OCT and ultra wide-field imaging.

Device: Optical coherence tomography angiography

Interventions

Optical coherence tomography angiographyDEVICE

Multiple scans of the retina will be recorded to evaluate microvascular changes.

OCTA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Care Center

Vancouver, V5Z 3N9, Canada

RECRUITING

Related Publications (1)

  • Karst SG, Heisler M, Lo J, Schuck N, Safari A, V Sarunic M, Maberley DAL, Navajas EV. Evaluating Signs of Microangiopathy Secondary to Diabetes in Different Areas of the Retina with Swept Source OCTA. Invest Ophthalmol Vis Sci. 2020 May 11;61(5):8. doi: 10.1167/iovs.61.5.8.

    PMID: 32392316DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Central Study Contacts

Eduardo Navajas, MD

CONTACT

604 875 5475edunavajas@gmail.com

Theresa Wiens

CONTACT

604-875-4111twiens@eyecarecentre.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2018

First Posted

December 5, 2018

Study Start

September 20, 2018

Primary Completion

July 1, 2022

Study Completion

March 31, 2023

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)