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Diabetic Macular Edema - Obstructive Sleep Apnea Relationship Study

NCT03597815 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2020-11-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the relationship between DME and obstructive sleep apnea (OSA). OSA impacts millions of North Americans, many of whom are undiagnosed. The investigators aim to evaluate if a relationship exists between the two diseases, whether or not the severity of OSA impacts the severity of DME, and whether treating OSA results in better treatment outcomes for DME. The study will involve the standard of care provided for both DME (involving anti-VEGF injections) and OSA (involving continuous positive airway pressure \[CPAP\] machine).Approximately 150 subjects are expected to be enrolled in this study.

In summary:

Question 1: Is there a correlation between DME and OSA? Question 2: Is there a relationship between the severity of DME (CRT and vision) and OSA (AHI index)? Question 3: Does treating OSA result in improving DME metrics, and does it neutralize the outcomes at 1 year compared to OSA negatives.

Conditions

Interventions

DRUG

Aflibercept 40 MG/ML [Eylea]

Intravitreal injection, form of anti-VEGF therapy

DIAGNOSTIC_TEST

OSA diagnostic test - overnight sleep study

Overnight with specialist care in hospital - heart, lung and brain activity monitored.

DEVICE

CPAP therapy for OSA positive patients

positive airway pressure ventilator, applies mild air pressure in a continuous basis to keep the airways continuously open in patients who are able to breath spontaneously on their own.

Sponsors & Collaborators

  • Uptown Eye Specialists

    lead OTHER

Principal Investigators

  • Sohel Somani · Uptown Eye

Eligibility

Min Age
18 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-03-31
Completion
2020-12-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03597815 on ClinicalTrials.gov