Nctid:
NCT06232616
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008269", "term"=>"Macular Edema"}, {"id"=>"D000019773", "term"=>"Epiretinal Membrane"}], "ancestors"=>[{"id"=>"D000008268", "term"=>"Macular Degeneration"}, {"id"=>"D000012162", "term"=>"Retinal Degeneration"}, {"id"=>"D000012164", "term"=>"Retinal Diseases"}, {"id"=>"D000005128", "term"=>"Eye Diseases"}], "browseLeaves"=>[{"id"=>"M11261", "name"=>"Macular Edema", "asFound"=>"Macular Edema", "relevance"=>"HIGH"}, {"id"=>"M7657", "name"=>"Edema", "relevance"=>"LOW"}, {"id"=>"M21675", "name"=>"Epiretinal Membrane", "asFound"=>"Epiretinal Membrane", "relevance"=>"HIGH"}, {"id"=>"M11260", "name"=>"Macular Degeneration", "relevance"=>"LOW"}, {"id"=>"M14997", "name"=>"Retinal Degeneration", "relevance"=>"LOW"}, {"id"=>"M14999", "name"=>"Retinal Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000003907", "term"=>"Dexamethasone"}], "ancestors"=>[{"id"=>"D000000893", "term"=>"Anti-Inflammatory Agents"}, {"id"=>"D000000932", "term"=>"Antiemetics"}, {"id"=>"D000001337", "term"=>"Autonomic Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000005765", "term"=>"Gastrointestinal Agents"}, {"id"=>"D000005938", "term"=>"Glucocorticoids"}, {"id"=>"D000006728", "term"=>"Hormones"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}], "browseLeaves"=>[{"id"=>"M7102", "name"=>"Dexamethasone", "asFound"=>"High", "relevance"=>"HIGH"}, {"id"=>"M235549", "name"=>"Dexamethasone acetate", "relevance"=>"LOW"}, {"id"=>"M4217", "name"=>"Anti-Inflammatory Agents", "relevance"=>"LOW"}, {"id"=>"M4251", "name"=>"Antiemetics", "relevance"=>"LOW"}, {"id"=>"M8881", "name"=>"Gastrointestinal Agents", "relevance"=>"LOW"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>20}}, "statusModule"=>{"overallStatus"=>"ENROLLING_BY_INVITATION", "startDateStruct"=>{"date"=>"2024-03-11", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-11", "studyFirstSubmitDate"=>"2024-01-04", "studyFirstSubmitQcDate"=>"2024-01-28", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-12", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"improvement of visual acuity", "timeFrame"=>"from baseline to postoperative 24 weeks", "description"=>"mean change in best corrected visual acuity"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Epiretinal Membrane"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to evaluate the efficacy and safety of 25-gauge pars plana vitrectomy combined with intravitreal dexamethasone implant for the treatment of idiopathic epiretinal membrane with cystoid macular oedema. The main questions it aims to answer are:\n\n* mean changes in best corrected visual acuity and central macular thickness from baseline to post-operative 24 weeks\n* mean change in proportion of cystoid macular oedema area from baseline to post-operative 24 weeks\n* intraocular pressure throughout postoperative 24 weeks\n* concentrations of inflammatory factors in vitreous samples Participants will undergo a standard three-port 25-gauge pars plana vitrectomy and epiretinal membrane peeling combined with phacoemulsification, aspiration, and intraocular lens implantation. The dexamethasone implant will be injected into the vitreous cavity at the end of the operation."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"40 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* symptomatic patients aged 40 years or above with idiopathic stage 3-4 epiretinal membrane defined on the basis of spectral-domain optical coherence tomography classification;\n* central retinal thickness \\>300 µm;\n* cystoid oedema within a 1 mm diameter range with the macular fovea as the center;\n* ocular axial length less than 25.00 mm.\n\nExclusion Criteria:\n\n* concomitant or previous macular diseases that may hinder visual improvement other than epiretinal membrane (e.g., age-associated macular degeneration, retinal vein occlusion, or diabetic macular oedema);\n* previous vitreoretinal surgery or intravitreal injection history;\n* history of glaucoma or optic neuropathy of any kind;\n* patients with uncontrolled systemic diseases or infectious diseases;\n* patients who took medicines that may have ocular side effects, such as glucocorticoid or hydroxychloroquine."}, "identificationModule"=>{"nctId"=>"NCT06232616", "briefTitle"=>"Vitrectomy Combined With Intravitreal Dexamethasone Implant for Idiopathic Epiretinal Membrane With Macular Oedema", "organization"=>{"class"=>"OTHER", "fullName"=>"Shanghai Eye Disease Prevention and Treatment Center"}, "officialTitle"=>"Vitrectomy Combined With Intravitreal Dexamethasone Implant for the Treatment of Idiopathic Epiretinal Membrane With Cystoid Macular Oedema", "orgStudyIdInfo"=>{"id"=>"YFZXYDK202401"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"OTHER", "label"=>"Single arm", "description"=>"In this single-arm designed study, participants with idiopathic epiretinal membranes with macular oedema were assigned a vitrectomy with an intravitreal dexamethasone implant.", "interventionNames"=>["Procedure: vitrectomy combined with intravitreal dexamethasone implant"]}], "interventions"=>[{"name"=>"vitrectomy combined with intravitreal dexamethasone implant", "type"=>"PROCEDURE", "description"=>"The dexamethasone implant will be injected into the vitreous cavity at the end of the surgery.", "armGroupLabels"=>["Single arm"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"200040", "city"=>"Shanghai", "state"=>"Shanghai", "country"=>"China", "facility"=>"Shanghai Eye Disease Prevention & Treatment Center", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}], "overallOfficials"=>[{"name"=>"Tao Sun, Ph.D.", "role"=>"STUDY_CHAIR", "affiliation"=>"Shanghai Eye Diseases Prevention & Treatment Center"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL"], "timeFrame"=>"after the results are published in the journal.", "ipdSharing"=>"YES", "description"=>"mean change in best corrected visual acuity throughout the study until the results are published in the journal.", "accessCriteria"=>"E-mail contact"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Shanghai Eye Disease Prevention and Treatment Center", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
