Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT03597867
Status:
COMPLETED
Last Update Posted:
2018-07-24
First Post:
2018-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PGE2 Levels in Patient Treated With NSAIDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'id': 'D012167', 'term': 'Retinal Perforations'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C414203', 'term': 'nepafenac'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'C053083', 'term': 'bromfenac'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-21', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-07-21', 'lastUpdatePostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitreous NSAIDs and PGE2 levels', 'timeFrame': '3 days after topical NSAID administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vitreoretinal surgery', 'epiretinal membrane', 'macular hole', 'non steroidal antinflammatory drugs', 'prostaglandin E2'], 'conditions': ['Ocular Inflammation']}, 'descriptionModule': {'briefSummary': "The aim of this study is to determine vitreous levels of nonsteroidal antinflammatory drugs (NSAIDs) and prostaglandinE2 (PGE2) in eyes scheduled for vitrectomy.\n\nAll patients received the study drugs for 3 days before surgery. 0.5 to 1.0 mL of undiluted vitreous was removed using the vitreous cutter positioned in the midvitreous cavity. Samples were immediately frozen and stored at -80°C until analysis.\n\nSample analyses were performed using an high-performance liquid chromatography system. The lower limit of quantitation was 0.8 ng/mL.\n\nPGE2 levels were analyzed using the Prostaglandin E2 Monoclonal EIA Kit (Cayman Chemical Company) according to the manufacturer's instructions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* epiretinal membrane or full thickness macular hole scheduled for vitrectomy\n\nExclusion Criteria:\n\n* vitreous hemorrhage\n* diabetes\n* glaucoma\n* concurrent retinovascular disease\n* previous ocular inflammation\n* previous ocular surgery\n* history of ocular trauma\n* previuos intravitreal injections\n* concomitant intake of topical or systemic NSAIDs or corticosteroid therapy'}, 'identificationModule': {'nctId': 'NCT03597867', 'briefTitle': 'PGE2 Levels in Patient Treated With NSAIDs', 'organization': {'class': 'OTHER', 'fullName': 'University of Trieste'}, 'officialTitle': 'Vitreous pge2 Level Changes After Topical Administration of Diclofenac 0.1%, Nepafenac 0.3%, Indomethacin 0.5% and Bromfenac 0.09% in Vitrectomy Patients', 'orgStudyIdInfo': {'id': '02/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo using single-use vials of hyaluronic acid 0.2% preservative-free lubricating tear drops three days before surgery.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dicloftil', 'description': 'Diclofenac Na 0.1% Oph Soln, "Dicloftil®", NSAID eyedrops administered three days before surgery', 'interventionNames': ['Drug: Dicloftil']}, {'type': 'EXPERIMENTAL', 'label': 'Nevanac', 'description': 'Nepafenac 0.3% Ophthalmic Suspension, "Nevanac 3mg/ml®", NSAID eyedrops administered three days before surgery', 'interventionNames': ['Drug: Nevanac']}, {'type': 'EXPERIMENTAL', 'label': 'Indom', 'description': 'Indomethacin 5 MG/ML Ophthalmic Suspension, "Indom ®", NSAID eyedrops administered three days before surgery', 'interventionNames': ['Drug: Indom']}, {'type': 'EXPERIMENTAL', 'label': 'Yellox', 'description': 'Bromfenac 0.09 % Ophthalmic Solution, "Yellox®", NSAID eyedrops administered three days before surgery', 'interventionNames': ['Drug: Yellox']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Tears'], 'description': 'Artificial tears for 3 days preoperatively', 'armGroupLabels': ['Placebo']}, {'name': 'Dicloftil', 'type': 'DRUG', 'otherNames': ['Diclofenac Na 0.1% Oph Soln'], 'description': 'Dosing of drug 3 days prior to surgery', 'armGroupLabels': ['Dicloftil']}, {'name': 'Nevanac', 'type': 'DRUG', 'otherNames': ['Nepafenac 0.3% Ophthalmic Suspension'], 'description': 'Dosing of drug 3 days prior to surgery', 'armGroupLabels': ['Nevanac']}, {'name': 'Indom', 'type': 'DRUG', 'otherNames': ['Indomethacin 5 MG/ML Ophthalmic Suspension'], 'description': 'Dosing of drug 3 days prior to surgery', 'armGroupLabels': ['Indom']}, {'name': 'Yellox', 'type': 'DRUG', 'otherNames': ['Bromfenac 0.09 % Ophthalmic Solution'], 'description': 'Dosing of drug 3 days prior to surgery', 'armGroupLabels': ['Yellox']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34129', 'city': 'Trieste', 'state': 'TS', 'country': 'Italy', 'facility': 'Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}], 'overallOfficials': [{'name': 'Marco R Pastore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eye Clinic, Departement of Medical Surgical Sciences and Health, University of Trieste Trieste, TS, 34129, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Trieste', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Marco Rocco Pastore', 'investigatorAffiliation': 'University of Trieste'}}}}