Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01701518
Status:
UNKNOWN
Last Update Posted:
2016-01-05
First Post:
2012-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-01-11', 'releaseDate': '2018-07-03'}], 'estimatedResultsFirstSubmitDate': '2018-07-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-04', 'studyFirstSubmitDate': '2012-10-03', 'studyFirstSubmitQcDate': '2012-10-03', 'lastUpdatePostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': '3 Months', 'description': 'Best corrected visual acuity measured before surgery and 3 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.'}], 'secondaryOutcomes': [{'measure': 'Best corrected visual acuity at 1,4 and 6 months', 'timeFrame': '6 months', 'description': 'Best corrected visual acuity measured at 1,4 and 6 months after surgery using an early treatment diabetic retinopathy study (ETDRS) chart.'}, {'measure': 'Retinal thickness and volume', 'timeFrame': '6 months', 'description': 'Measure the change in retinal thickness and volume from baseline and at 1, 3, 4, 6 months using optical coherence tomography (OCT).'}, {'measure': 'Intraocular pressure (IOP)', 'timeFrame': '6 months', 'description': 'Change of IOP from baseline will be monitored.'}, {'measure': 'Cataract progression (if applicable)', 'timeFrame': '6 months', 'description': 'For phakic patients, cataract progression from baseline to the 6 months visit will also be monitored.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ozurdex', 'Dexamethasone', 'Epiretinal membrane', 'Macular edema'], 'conditions': ['Epiretinal Membrane', 'Macular Edema']}, 'descriptionModule': {'briefSummary': 'To determine if an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes is safe and effective to decrease the macular edema, as demonstrated by a gain in vision and decreased in retinal thickness and volume.', 'detailedDescription': 'We believe that the use of intravitreal corticosteroids post-operatively has the capacity to mitigate much of the residual swelling and retinal thickening that is seen after vitrectomy for epiretinal membranes. The unique pharmacokinetics of the sustained released dexamethasone implant (Ozurdex®) makes it an ideal delivery system to use post-vitrectomy for epiretinal membrane surgery. Its duration of action and its drug delivery characteristics over 6 months approximately match the post-operative time course of healing and remodeling in an edematous retina.\n\nThis is a prospective, multicentre, pilot study evaluating the efficacy of an intravitreal sustained release dexamethasone implant (Ozurdex®) injected at the conclusion of surgery in 15 patients undergoing vitrectomy and membrane peeling for idiopathic epiretinal membranes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing vitrectomy surgery for a visually significant (≤ 20/50) idiopathic epiretinal membrane.\n* Central retinal thickness ≥ 250 μm.\n* Age more than 18 years old.\n* Decision makers able to give informed consent.\n* Females of child bearing potential must agree to use acceptable means of birth control for the duration of the study.\n\nExclusion Criteria:\n\n* Secondary epiretinal membranes (ex: secondary to a retinal vein occlusion, etc.).\n* Any other macular pathology that could affect anatomic or functional results.\n* History of uveitis requiring intravitreal triamcinolone injection.\n* History of steroid-responsive glaucoma.\n* History of moderate or advanced glaucoma (cup to disc ratio ≥ 0.7).\n* IOP \\> 23 mm Hg if untreated, or \\> 21 mm Hg if treated with medication.\n* Pregnant or breast-feeding woman.\n* Unable to attend the scheduled follow-up appointments.\n* Patients with known hypersensitivity to any components of Ozurdex® or to other corticosteroids.\n* Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.'}, 'identificationModule': {'nctId': 'NCT01701518', 'briefTitle': 'A Pilot Study of the Effectiveness of Intra-operative Ozurdex® in Vitrectomy Surgery for Epiretinal Membranes', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'A Prospective Multicentre Pilot Study of the Effectiveness of an Intra-operative Intravitreal Sustained Release Dexamethasone Implant (Ozurdex®) in Vitrectomy Surgery for Epiretinal Membranes', 'orgStudyIdInfo': {'id': 'OZ123'}, 'secondaryIdInfos': [{'id': 'OZ123', 'type': 'OTHER', 'domain': 'Health Canada'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ozurdex', 'description': 'Intra-operative Ozurdex (biodegradable 0.7mg dexamethasone implant) post-vitrectomy for epiretinal membrane', 'interventionNames': ['Drug: Ozurdex']}], 'interventions': [{'name': 'Ozurdex', 'type': 'DRUG', 'otherNames': ['0.7mg dexamethasone implant'], 'description': 'biodegradable 0.7mg dexamethasone implant', 'armGroupLabels': ['Ozurdex']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Charlene Muller', 'role': 'CONTACT', 'email': 'charlene.muller@sunnybrook.ca', 'phone': '416-480-5091'}, {'name': 'Peter J Kertes, MD,CM,FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5C 2T2', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Rajeev Muni, MD, FRCSC', 'role': 'CONTACT', 'email': 'rajeev.muni@utoronto.ca', 'phone': '(416) 867-7422'}, {'name': 'Rajeev Muni, MD,FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Charlene Muller', 'role': 'CONTACT', 'email': 'charlene.muller@sunnybrook.ca', 'phone': '416-480-5091'}], 'overallOfficials': [{'name': 'Peter J Kertes, MD,CM,FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Unity Health Toronto', 'class': 'OTHER'}, {'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-07-03', 'type': 'RELEASE'}, {'date': '2019-01-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Sunnybrook Health Sciences Centre'}}}}