Obstructive Sleep Apnea and Diabetic Macular Edema Inflammatory Mediators

November 23, 2020 updated by: Uptown Eye Specialists

Impact of Obstructive Sleep Apnea on the Expression of Inflammatory Mediators in Diabetic Macular Edema

Obstructive sleep apnea (OSA) is characterized by intermittent nocturnal hypoxemia, frequent arousals, fragmented sleep and daytime sleepiness. It has been shown to increase the risk of cardiac and vascular disease through multiple mechanisms including sympathetic hyperactivity, metabolic dysregulation, and activation of oxidative stress and inflammatory pathways.

Diabetic retinopathy is a leading cause of blindness in the working age group, affecting 93 million people worldwide. Diabetic macular edema (DME) is a sight threatening complication and the most common cause of visual loss in patients with diabetes. OSA is frequently associated with diabetes with prevalence ranging from 23 to 86%. However, the relationship between OSA and DME is not well defined. The retina is especially susceptible to hypoxia, being one of the most metabolically active tissues. Many of the same inflammatory mediators have also been found to be elevated in patients with diabetic macular edema, including VEGF, VCAM-1 and IL-6.

There has been no previous study examining the biochemical impact of OSA on patients with DME. We aim to explore this relationship by examining the differences in inflammatory markers expressed in patients with DME who have undergone an overnight sleep study, which is considered the gold standard diagnostic tool in OSA.

Study Overview

Status

Unknown

Conditions

Detailed Description

The purpose of this study is to compare the levels of inflammatory mediators in diabetic patients with macular edema with and without OSA.

This will be a single centre, prospective, cross-sectional study. We will be recruiting patients undergoing intravitreal injection for diabetic macular edema divided into 2 groups:

  • Group 1: diabetic patients with macular edema, no OSA
  • Group 2: diabetic patients with macular edema, and OSA

All patients will undergo baseline ophthalmologic examination as part of a regular clinic visit including best-corrected visual acuity, intraocular pressure, slit lamp exam, dilated retinal exam, fluorescein angiography and optical coherence tomography (OCT). Diagnosis of diabetic macular edema will be confirmed with standard domain OCT. Diagnosis of OSA will be confirmed through gold standard of overnight polysomnography.

Data including demographics, ocular history, best corrected visual acuity, IOP, blood sugar control and sleep metrics will be collected. Serum and aqueous fluid samples will be collected at time of first intravitreal injection including VEGF, Placental growth factor, TGFB, ICAM-1,IL-2, IL-3, IL-6, IL-8, IL-10,IL-17, VCAM-1, MCP-1, Epidermal growth factor, Pigment epithelial derived factor (PEDF), Angiotensin 2 and Platelet derived growth factor (PDGF).

Primary outcome:

Levels of cytokine in serum and aqueous humour

Secondary outcome:

Best-corrected visual acuity

Data analysis:

Level of cytokines in serum and aqueous humor in patients with and without OSA will be compared using T test. Statistical significance is defined as p < 0.05.

Study Type

Observational

Enrollment (Actual)

30

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

  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6Y0P6
        • Uptown Eye Speicialists

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Type I/II diabetic patients with diabetic macular edema undergoing first intravitreal injection.

Description

Inclusion Criteria:

  • Type I/II diabetic patients with evidence of diabetic macular edema requiring treatment with anti-VEGF

Exclusion Criteria:

  • Contraindications to intravitreal injection including stroke within the past month, ocular or peri-ocular infection, active intraocular inflammation, hypersensitivity to components of the intra-vitreal injection
  • Any other retinal or macular pathology such as retinal detachment and age related macular degeneration
  • Patients that have taken any systemic immunosuppressive or anti-inflammatory within the past 30 days
  • Impaired mental capacity to comply (eg. dementia)
  • Pregnant or breastfeeding women

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

Cohorts and Interventions

Group / Cohort
OSA + DME +
Patients with OSA and DME
OSA - DME +
Patients with DME, but no evidence of OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokines
Time Frame: Jan 2018- Mar 2020
Level of cytokines between patients with and without OSA
Jan 2018- Mar 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uptown Eye Specialists

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)

January 1, 2018

Primary Completion (ACTUAL)

March 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

November 23, 2020

First Posted (ACTUAL)

December 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSA-DME 2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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