Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT04648618
Status:
UNKNOWN
Last Update Posted:
2020-12-01
First Post:
2020-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Obstructive Sleep Apnea and Diabetic Macular Edema Inflammatory Mediators
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-11-23', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cytokines', 'timeFrame': 'Jan 2018- Mar 2020', 'description': 'Level of cytokines between patients with and without OSA'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetic macular edema', 'obstructive sleep apnea'], 'conditions': ['Diabetic Macular Edema', 'Obstructive Sleep Apnea', 'Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': '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.\n\nDiabetic 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.\n\nThere 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.', 'detailedDescription': 'The purpose of this study is to compare the levels of inflammatory mediators in diabetic patients with macular edema with and without OSA.\n\nThis 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:\n\n* Group 1: diabetic patients with macular edema, no OSA\n* Group 2: diabetic patients with macular edema, and OSA\n\nAll 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.\n\nData 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).\n\nPrimary outcome:\n\nLevels of cytokine in serum and aqueous humour\n\nSecondary outcome:\n\nBest-corrected visual acuity\n\nData analysis:\n\nLevel 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.'}, 'eligibilityModule': {'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Type I/II diabetic patients with diabetic macular edema undergoing first intravitreal injection.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type I/II diabetic patients with evidence of diabetic macular edema requiring treatment with anti-VEGF\n\nExclusion Criteria:\n\n* 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\n* Any other retinal or macular pathology such as retinal detachment and age related macular degeneration\n* Patients that have taken any systemic immunosuppressive or anti-inflammatory within the past 30 days\n* Impaired mental capacity to comply (eg. dementia)\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT04648618', 'briefTitle': 'Obstructive Sleep Apnea and Diabetic Macular Edema Inflammatory Mediators', 'organization': {'class': 'OTHER', 'fullName': 'Uptown Eye Specialists'}, 'officialTitle': 'Impact of Obstructive Sleep Apnea on the Expression of Inflammatory Mediators in Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'OSA-DME 2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OSA + DME +', 'description': 'Patients with OSA and DME'}, {'label': 'OSA - DME +', 'description': 'Patients with DME, but no evidence of OSA'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L6Y0P6', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Uptown Eye Speicialists', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uptown Eye Specialists', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}