Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-24 @ 11:13 PM
Study NCT ID:
NCT02272569
Status:
COMPLETED
Last Update Posted:
2021-02-15
First Post:
2014-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STARflo European Safety and Efficacy Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-01-27', 'releaseDate': '2022-04-27'}, {'resetDate': '2023-11-20', 'releaseDate': '2023-01-30'}], 'estimatedResultsFirstSubmitDate': '2022-04-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-11', 'studyFirstSubmitDate': '2014-10-21', 'studyFirstSubmitQcDate': '2014-10-22', 'lastUpdatePostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP', 'timeFrame': '12 months', 'description': 'IOP of each patients at baseline will be compared to IOP of patient after 12 months'}], 'secondaryOutcomes': [{'measure': 'Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP', 'timeFrame': '24 months', 'description': 'IOP of each patients at baseline will be compared to IOP of patient after 24 months'}, {'measure': 'Reduction in number of IOP lowering medications at 12 months vs. baseline', 'timeFrame': '12 months', 'description': 'compare number of active ingredient of each patients at baseline vs number of active ingredient after 12 months'}, {'measure': 'Reduction in number of IOP lowering medications at 24 months vs. baseline', 'timeFrame': '24 months', 'description': 'compare number of active ingredient of each patients at baseline vs number of active ingredient after 24 months'}, {'measure': 'Rate of adverse events', 'timeFrame': '24 months', 'description': 'assessment and counting of adverse events (% by adverse event) including procedure related complications'}, {'measure': 'Visual Acuity', 'timeFrame': '12 months', 'description': 'comparison of visual acuity at 12 months vs. baseline'}, {'measure': 'Absolute success rate (%) at 12 months', 'timeFrame': '12 months', 'description': 'absolute success: IOP \\< 21mmHg and \\< 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication'}, {'measure': 'Qualified success rate (%) at 12 months', 'timeFrame': '12 months', 'description': 'qualified success: IOP \\< 21mmHg and \\< 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication'}, {'measure': 'Qualified success rate (%) at 24 months', 'timeFrame': '24 months', 'description': 'qualified success: IOP \\< 21mmHg and \\< 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication'}, {'measure': 'Absolute success rate (%) at 24 months', 'timeFrame': '24 months', 'description': 'absolute success: IOP \\< 21mmHg and \\< 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glaucoma', 'glaucoma drainage device', 'glaucoma shunt'], 'conditions': ['Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.', 'detailedDescription': 'This is a prospective, multicenter clinical trial to assess the efficacy and the safety of the STARflo™ Glaucoma Implant.\n\nPatients will enter the study after providing written informed consent. Patients will be screened to confirm that they are eligible for study participation.\n\nWhen eligibility has been established using the in/exclusion criteria, surgery will be scheduled.\n\nPre and post-surgery, patients will be evaluated at scheduled intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months) for a total duration of 24 months following surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Diagnosis of refractory open angle glaucoma\n* Documented 21 mmHg \\< IOP ≤ 40 mmHg, under medication\n* Patient must provide written informed consent\n\nMain Exclusion Criteria:\n\n* Patients with diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye\n* Patients who failed one or more cilio ablative procedure in the study eye if these cilio ablative procedures were performed as a consequence of previous failed filtering surgery\n* Clinically significant intra-ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye'}, 'identificationModule': {'nctId': 'NCT02272569', 'briefTitle': 'STARflo European Safety and Efficacy Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'iSTAR Medical'}, 'officialTitle': 'A Prospective, Non-comparative, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the STARflo Glaucoma Implant in Patients With Open Angle Glaucoma', 'orgStudyIdInfo': {'id': 'ISM01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STARflo Glaucoma Implant', 'description': 'Implantation of the STARflo Glaucoma Implant by an ab-externa technique with connection from the anterior chamber to the suprachoroidal space', 'interventionNames': ['Device: STARflo Glaucoma Implant']}], 'interventions': [{'name': 'STARflo Glaucoma Implant', 'type': 'DEVICE', 'description': 'Implantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications.', 'armGroupLabels': ['STARflo Glaucoma Implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'UZA', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'MHAT Central Onco Hospital', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '69417', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital de la Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Paris', 'country': 'France', 'facility': 'CHNO des Quinze Vingts', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University Clinic Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '80336', 'city': 'Munich', 'country': 'Germany', 'facility': 'Ludwig-Maximilians-University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Universitatsklinik fur Augenheilkunde Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Zubair Hussain, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sponsor Representative'}, {'name': 'Sheng Lim, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical Advisor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iSTAR Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-04-27', 'type': 'RELEASE'}, {'date': '2023-01-27', 'type': 'RESET'}, {'date': '2023-01-30', 'type': 'RELEASE'}, {'date': '2023-11-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'iSTAR Medical'}}}}