Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT00382395
Status:
SUSPENDED
Last Update Posted:
2015-09-18
First Post:
2006-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany', 'Italy', 'Spain', 'Switzerland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-17', 'studyFirstSubmitDate': '2006-09-27', 'studyFirstSubmitQcDate': '2006-09-27', 'lastUpdatePostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage reduction in IOP at both 12 and 24 months after implant', 'timeFrame': '1 & 2 years'}], 'secondaryOutcomes': [{'measure': 'Absolute IOP', 'timeFrame': '1 & 2 years'}, {'measure': 'Mean number of glaucoma medications', 'timeFrame': '1 & 2 years'}, {'measure': 'Success rate', 'timeFrame': '1 & 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma shunt', 'Ocular implant', 'Gold', 'trabeculectomy'], 'conditions': ['Glaucoma', 'Glaucoma, Open Angle']}, 'descriptionModule': {'briefSummary': 'Study Objective:\n\nTo establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.', 'detailedDescription': 'This protocol is a randomized, controlled, multi-center, outpatient study to compare the IOP lowering ability and safety profile of the SOLX Gold Shunt to the selected, commercially available aqueous shunt product (i.e., Control shunt Model FP7 Ahmed™ Glaucoma Valve Flexible Plate™) for a period of up to one year. Extended follow up is scheduled for a period not to exceed two years, should this be necessary for regulatory purposes. Follow-up beyond one year will be expected unless other patients with SOLX Gold Shunt implants in earlier phase studies outside the US clearly show no significant adverse effects associated with the long-term use of the device for follow-up periods exceeding one year, and this information is deemed adequate to reduce the required follow-up period under this protocol to a shorter period, such as 6 months for the last-to-enter patients at the time of filing for 510(k) marketing clearance review with the FDA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary open-angle, pseudoexfoliative, or pigmentary glaucoma\n* Age 21 or over\n* refractory glaucoma, with IOP \\>21 mmHg on medications and failed prior incisional glaucoma surgery\n* detectable visual field defect (negative MD score)\n* written consent\n* available for up to 24 months follow-up\n\nExclusion Criteria:\n\n* either eye with VA worse than count fingers\n* recent angle closure glaucoma episode\n* uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma\n* other significant ocular disease, except cataract\n* active ocular infection\n* expected ocular surgery in next 12 months\n* no suitable quadrant for implant\n* systemic corticosteroid therapy \\> 5 mg/day prednisone\n* intolerance to gonioscopy or other eye exams\n* mental impairment interfering with consent or compliance\n* pregnancy\n* known sensitivity to anticipated medications used at surgery\n* significant co-morbid disease\n* concurrent enrollment in another drug or device study'}, 'identificationModule': {'nctId': 'NCT00382395', 'briefTitle': 'SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'SOLX, Inc.'}, 'officialTitle': 'Randomized, Controlled, Multicenter Comparative Trial to Evaluate the SOLX Gold Shunt for the Reduction of Intraocular Pressure (IOP) in Glaucomatous Eyes Following Failed Medical and Conventional Surgical Treatments', 'orgStudyIdInfo': {'id': 'SLX53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'SOLX Gold Shunt', 'interventionNames': ['Device: SOLX Gold Shunt GMS-plus']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Control Ahmed FP7 Shunt', 'interventionNames': ['Device: Ahmed FP7 Glaucoma Valve']}], 'interventions': [{'name': 'SOLX Gold Shunt GMS-plus', 'type': 'DEVICE', 'description': 'Single use implant', 'armGroupLabels': ['1']}, {'name': 'Ahmed FP7 Glaucoma Valve', 'type': 'DEVICE', 'description': 'Single use implant', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94954', 'city': 'Petaluma', 'state': 'California', 'country': 'United States', 'facility': 'North Bay Eye Associates', 'geoPoint': {'lat': 38.23242, 'lon': -122.63665}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Glaucoma Consultants of Colorado', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'International Eye Care', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Price Vision Group', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '07103', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'University of Medicine and Dentistry of New Jersey', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Glaucoma Associates of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '74132', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Eagle Mountain Vision', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38163', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee / Hamilton Eye Institute', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': 'L5L 1W8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Credit Valley EyeCare', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'H1V 1G5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut du Glaucome de Montréal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '400 007', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Bombay City Eye Institute & Research Centre', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '600 006', 'city': 'Chennai', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Vision Research Foundation / Sankara Nethralaya', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Chaim Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '09-909', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Military Institute of the Health Services', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Jan S. Peterson, MS, RAC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Emmes Company, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SOLX, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Doug Adams', 'oldOrganization': 'SOLX, Inc.'}}}}