NCT03597815

Diabetic Macular Edema - Obstructive Sleep Apnea Relationship Study

Examining the Relationship Between Diabetic Macular Edema and Obstructive Sleep Apnea: Prevalence, Association and Impact.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Uptown Eye Specialists · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A 12 month, non-randomized, controlled, prospective study evaluating the relationship between diabetic macular edema (DME) and obstructive sleep apnea (OSA). Subjects eligible for the inclusion in the study will be grouped based on their diagnosis: DME \& OSA positive, DME positive only, OSA positive only, and DME \& OSA negative. All DME positive patients (irrespective of OSA status) will receive the standard of care treatment with anti-VEGF using Eylea in a standardized treat and extend protocol. All patients will undergo baseline ophthalmologic examinations 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. During each visit, the intraocular pressure and perfusion of the optic nerve head will be monitored for patient safety. DME positive patients will receive a minimum of 6 injections with the first five occurring at 1-month intervals and the sixth occurring two months after the fifth. Further injections will be provided at the discretion of the ophthalmologist in according to the treat and extend protocol of Eylea. Data for Visits 1 and 4 in Table 1 will be collected at the first and sixth injections whereas the other injection visits will be treated as regular office visits and not study visits. The investigators aim to identify the presence of OSA using the gold standard testing of an overnight sleep study to determine the prevalence of OSA in the DME population. Further, the investigators will attempt to determine if there is a correlation of OSA by comparing it to non-DME patients who have NPDR. The mechanism of OSA action on diabetic microvascular complications may involve increased inflammatory responses and oxidative stress pathways such as increased advanced glycation end products. By comparing the gold standard metric of severity index of OSA (Apnea-hypopnea index) to DME metrics (LogMAR Snellen vision and CRT) at the baseline of both disease diagnoses, the investigators can determine severity association. The specific metrics of DME treatment (Vision, CRT, number of injections) will be compared to pre-CPAP data to determine what the impact of CPAP was (if any) on DME treatment metrics. Further, the investigators aim to compare the one-year post-CPAP DME treatment metrics against one-year non-CPAP/non-OSA patients to determine the relative impact against a control group.

Conditions

• Diabetic Macular Edema
• Sleep Apnea
• Non Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-03-31
• Completion: 2020-12-01
• First posted: 2018-07-24
• Last updated: 2020-11-24

Locations

1 site across 1 country: Canada