Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-01-03 @ 7:54 PM
Study NCT ID:
NCT03624361
Status:
COMPLETED
Last Update Posted:
2022-08-09
First Post:
2018-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MINIject Glaucoma Implant in European Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'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', 'interventionModelDescription': 'MINIject glaucoma implant CS600 with Dual Operator Delivery Tool'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2018-05-28', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualified success for lowering the IOP', 'timeFrame': 'at 6 months', 'description': "The primary objective is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21 mmHg and \\> 5 mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery"}], 'secondaryOutcomes': [{'measure': 'Safety assessment of device in terms of adverse events (AEs) and serious adverse events (SAEs) reported during duration of study', 'timeFrame': 'up to 24 months after surgery', 'description': 'show safety of the MINIject implant and the procedure used to implant the device'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Minimally Invasive Glaucoma Surgery', 'Glaucoma Implant', 'Lower IOP', 'IOP', 'Intraocular Pressure'], 'conditions': ['Glaucoma, Open-Angle', 'Glaucoma Eye', 'Intraocular Pressure']}, 'referencesModule': {'references': [{'pmid': '32769736', 'type': 'RESULT', 'citation': 'Garcia Feijoo J, Denis P, Hirneiss C, Aptel F, Perucho Gonzalez L, Hussain Z, Lorenz K, Pfeiffer N; STAR-II Investigators. A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II). J Glaucoma. 2020 Oct;29(10):864-871. doi: 10.1097/IJG.0000000000001632.'}], 'seeAlsoLinks': [{'url': 'https://www.istarmed.com/', 'label': 'Homepage of the company and information about the product'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.', 'detailedDescription': "The primary endpoint is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21mmHg (millimeter mercury) and \\> 5mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females, 50 years of age or older.\n* Diagnosis of primary open angle glaucoma during screening visit or earlier.\n* Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shafer Angle Grading System.\n\nExclusion Criteria:\n\n* Diagnosis of glaucoma other than primary open angle glaucoma (e.g. angle closure glaucoma or secondary open angle glaucoma) in the study eye.\n* Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shafer Angle Grading System.\n* Neovascular glaucoma in the study eye.\n* Corneal opacity or iridocorneal angle not visible through gonioscopy prisma in the study eye, preventing correct placement of the implant.'}, 'identificationModule': {'nctId': 'NCT03624361', 'acronym': 'STAR-II', 'briefTitle': 'MINIject Glaucoma Implant in European Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'iSTAR Medical'}, 'officialTitle': 'A Prospective, Open, Multicentre Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in European Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications', 'orgStudyIdInfo': {'id': 'STAR-II (ISM04EU)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stand-alone', 'description': 'Patients will receive MINIject Glaucoma implant in a stand-alone procedure.\n\nMINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.', 'interventionNames': ['Device: Glaucoma device implantation in a stand-alone procedure']}], 'interventions': [{'name': 'Glaucoma device implantation in a stand-alone procedure', 'type': 'DEVICE', 'description': 'MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.\n\nThe intervention is to be performed as stand-alone surgery.', 'armGroupLabels': ['Stand-alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'Center Hospotalier Universitaire Genoble Alpes', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '80336', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Ludwig-Maximilians-University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '44892', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Uni-Augenklinik Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '50937', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Uniklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Universitätsklinikum Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Norbert Pfeiffer, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Mainz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iSTAR Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}