Diabetic Macular EdemaNCT04648618
Obstructive Sleep Apnea and Diabetic Macular Edema Inflammatory Mediators
An observational study of Diabetic Macular Edema and Obstructive Sleep Apnea, run by Uptown Eye Specialists at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Obstructive Sleep Apnea, Diabetic Retinopathy
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- No healthy volunteers
- Adult, Older adult
Study population: Type I/II diabetic patients with diabetic macular edema undergoing first intravitreal injection.
Who may be able to join
- Type I/II diabetic patients with evidence of diabetic macular edema requiring treatment with anti-VEGF
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- diabetic macular edema, obstructive sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| OSA + DME + | Patients with OSA and DME | |
| OSA - DME + | Patients with DME, but no evidence of OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines
Level of cytokines between patients with and without OSA
Measured: Jan 2018- Mar 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Jan 2018
- Primary completion31 Mar 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uptown Eye Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648618
- Sponsor's protocol ID
- OSA-DME 2
- Status last verified
- Nov 2020
- First submitted
- 23 Nov 2020
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obstructive Sleep Apnea on the Expression of Inflammatory Mediators in Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT04648618
- Acronym / sponsor ID
- OSA-DME 2
- Keywords
- diabetic macular edema, obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uptown Eye SpecialistsUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA + DME + | – | –Patients with OSA and DME |
| OSA - DME + | – | –Patients with DME, but no evidence of OSA |
Who may qualify
- Ages
- 18 years and older
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type I/II diabetic patients with diabetic macular edema undergoing first intravitreal injection.
Key inclusion criteria (1 listed)
- Type I/II diabetic patients with evidence of diabetic macular edema requiring treatment with anti-VEGF
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cytokines
Time frame: Jan 2018- Mar 2020
Level of cytokines between patients with and without OSA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema and Obstructive Sleep Apnea, run by Uptown Eye Specialists at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokines (time frame: Jan 2018- Mar 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.