Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-27 @ 9:20 PM
Study NCT ID:
NCT05024695
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2021-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D000080324', 'term': 'Choroidal Effusions'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005124', 'term': 'Eye Abnormalities'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Person(s) checking intraocular pressures are masked, except for day of surgery, throughout the duration of the trial.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 975}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-07', 'studyFirstSubmitDate': '2021-08-23', 'studyFirstSubmitQcDate': '2021-08-23', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure decrease', 'timeFrame': '24 months', 'description': 'Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated Diurnal IOP at Month 24.'}, {'measure': 'Intraocular pressure decrease (outcome 2)', 'timeFrame': '24 months', 'description': 'Change from baseline in mean unmedicated diurnal IOP at Month 24.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['glaucoma', 'MIGS', 'primary open angle glaucoma', 'suprachoroidal space', 'supraciliary space'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': "Evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.", 'detailedDescription': "This is a prospective, multicenter, masked clinical trial to evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '46 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Males and females, 46 years of age or older\n* A diagnosis of primary open-angle glaucoma, who are candidates for medical therapy, laser treatment, or glaucoma-filtering surgery\n* Pseudophakic with prior uncomplicated cataract surgery\n\nKey Exclusion Criteria:\n\n* Angle closure, congenital, or secondary glaucoma\n* Diagnosed degenerative visual disorders\n* Clinically significant intraocular inflammation or infection'}, 'identificationModule': {'nctId': 'NCT05024695', 'acronym': 'STAR-V', 'briefTitle': "Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.", 'organization': {'class': 'INDUSTRY', 'fullName': 'iSTAR Medical'}, 'officialTitle': 'A Prospective, Multicenter Masked Clinical Trial to Evaluate the Safety and Effectiveness of the MINIject CS627 Implant in Subjects With Open Angle Glaucoma', 'orgStudyIdInfo': {'id': 'ISM06 (STAR-V)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Implant Group', 'interventionNames': ['Device: MINIject™ Implant']}], 'interventions': [{'name': 'MINIject™ Implant', 'type': 'DEVICE', 'description': 'The MINIject™ SO627 is an integrated system for Minimally Invasive Glaucoma Surgery (MIGS) comprised of a glaucoma drainage implant, the MINIject™ SO627 and the SO Delivery System, designed to deliver the MINIject™ implant into the supraciliary space.', 'armGroupLabels': ['Implant Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Advanced Eye Research Institute', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Vold Vision', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Beverly Hills Institute of Ophthalmology', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '95926', 'city': 'Chico', 'state': 'California', 'country': 'United States', 'facility': 'Reeve Woods Eye Center', 'geoPoint': {'lat': 39.72849, 'lon': -121.83748}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sacramento Eye Consultants, A Medical Corporation', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '81501', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': 'Grand Junction Eye Care', 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Eye Associates of Fort Myers', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '83616', 'city': 'Eagle', 'state': 'Idaho', 'country': 'United States', 'facility': 'Intermountain Eye Center', 'geoPoint': {'lat': 43.69544, 'lon': -116.35401}}, {'zip': '61615', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Eye Center', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61201', 'city': 'Rock Island', 'state': 'Illinois', 'country': 'United States', 'facility': 'Virdi Eye Clinic', 'geoPoint': {'lat': 41.50948, 'lon': -90.57875}}, {'zip': '66213', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Stiles Eyecare Excellene and Glaucoma Institute', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '71303', 'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LA Eye and Laser', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'zip': '55431', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Eye Consultants', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '68124', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Eye Consultants PC', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89145', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Center for Sight Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Ophthalmology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45040', 'city': 'Mason', 'state': 'Ohio', 'country': 'United States', 'facility': 'Apex Eye Clinical Research, LLC', 'geoPoint': {'lat': 39.36006, 'lon': -84.30994}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Eye Surgeons', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Eye Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Glaucoma Associates of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '79922', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'El Paso Eye Surgeons', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '76102', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Ophthalmology Associates', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Eye Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77027', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Berkeley Eye Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'R and R Eye Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'The Eye Institute of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Spokane Eye Clinical Research', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53142', 'city': 'Kenosha', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Eye Centers of Racine and Kenosha', 'geoPoint': {'lat': 42.58474, 'lon': -87.82119}}, {'zip': 'L6H 0J8', 'city': 'Oakville', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Prism Eye Institute', 'geoPoint': {'lat': 43.45011, 'lon': -79.68292}}, {'zip': 'J7N0C2', 'city': 'Boisbriand', 'state': 'Quebec', 'country': 'Canada', 'facility': "The Institute de l'Oeil des Laurentides", 'geoPoint': {'lat': 45.61678, 'lon': -73.83249}}, {'city': 'Montreal', 'country': 'Canada', 'facility': 'Clinique Opthalmologies Bellevue', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Swiss Glaucoma Research Foundation Swiss Visio Montchoisi', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'East Grinstead', 'country': 'United Kingdom', 'facility': 'Queen Victoria Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.12382, 'lon': -0.0061}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Glaucoma Service Moorfields Eye Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust Western Eye Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "KCL Frost Eye Research Department St Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'York', 'country': 'United Kingdom', 'facility': 'Research & Development Unit, Learning and Research Centre (LaRC), York Hospital', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}], 'overallOfficials': [{'name': 'Sabine Glibert', 'role': 'STUDY_DIRECTOR', 'affiliation': 'iSTAR Medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iSTAR Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}