Diabetic Macular Edema - Obstructive Sleep Apnea Relationship Study (DME-OSA)

Uptown Eye Specialists

Status: Unknown

Conditions: Diabetic Macular Edema; Sleep Apnea; Non Proliferative Diabetic Retinopathy

Treatments: Diagnostic Test: OSA diagnostic test - overnight sleep study; Drug: Aflibercept 40 MG/ML [Eylea]; Device: CPAP therapy for OSA positive patients

Study type: Observational

Funder types: Other

Identifiers

NCT03597815

DME-OSA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or greater
• Ability to understand and provide written consent
• Type II diabetes patients and evidence of Diabetic Retinopathy
• Patients with and without DME
• Able and willing to comply with all treatment and follow-up procedures

Exclusion criteria

• Contraindications to Eylea including: stroke within the past month, ocular or periocular infection, active intraocular inflammation, hypersensitivity to Eylea and/or its excipients.
• Contraindication to CPAP including: severe bullous lung disease, pneumothorax, pathologically low blood pressure, dehydration, cerebrospinal fluid leak, recent cranial surgery, or trauma
• Any other types of retinal diseases such as retinal detachment
• Any other types of macular disease such as age-related macular degeneration
• Mental capacity to comply is impaired (i.e. dementia)
• Pregnant or breastfeeding women
• Participation in any drug or device clinical investigation within 30 days prior to entry into the study

Trial design

150 participants in 4 patient groups

DME positive, OSA positive

Description:

Visit 1: Baseline DME Treatment. Includes first EYELEA(aflibercept) injection. (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 to ensure the DME is resolved by the end of the study.) Each injection is 2 mg (0.05 mL). Visit 2: Diagnosis of OSA - Overnight sleep study Visit 3: 1 month follow up post-CPAP initiation Visit 4: 6-month visit post DME initial treatment Visit 5: 2-3 month follow up - titration study (at sleep lab) Visit 6: 12-month visit post DME initial treatment in the OSA- group and at least 3 months post CPAP initiation in the OSA+ group Visit 7: 12-month sleep apnea follow up

Treatment:

Device: CPAP therapy for OSA positive patients

Diagnostic Test: OSA diagnostic test - overnight sleep study

Drug: Aflibercept 40 MG/ML [Eylea]

DME positive, OSA negative

Description:

Visit 1: Baseline DME Treatment Includes first EYELEA(aflibercept) injection. (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 to ensure the DME is resolved by the end of the study.) Each injections is 2 mg (0.05 mL). Visit 2: Diagnosis of OSA - Overnight sleep study Visit 3: 6-month visit post DME initial treatment Visit 4: 12-month visit post DME initial treatment in the OSA- group and at least 3 months post CPAP initiation in the OSA+ group

Treatment:

Diagnostic Test: OSA diagnostic test - overnight sleep study

Drug: Aflibercept 40 MG/ML [Eylea]

DME negative (NPDR positive), OSA positive

Description:

no injections needed. Visit 1: Baseline NPDR diagnosis Sleep lab visits Visit 2: Diagnosis of OSA - Overnight sleep study Visit 3: 1 month follow up post-CPAP initiation Visit 4: 2-3 month follow up - titration study Visit 5: 12-month sleep apnea follow up

Treatment:

Device: CPAP therapy for OSA positive patients

Diagnostic Test: OSA diagnostic test - overnight sleep study

DME negative (NPDR positive), OSA negative

Description:

no injections needed. Visit 1: Baseline NPDR diagnosis Visit 2: Diagnosis of OSA - Overnight sleep study

Treatment:

Diagnostic Test: OSA diagnostic test - overnight sleep study