Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-31 @ 8:42 PM
Study NCT ID:
NCT01640756
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AqueSys Microfistula Implant in Refractory 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'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'dispFirstSubmitDate': '2016-01-11', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-11', 'studyFirstSubmitDate': '2012-07-12', 'dispFirstSubmitQcDate': '2016-01-11', 'studyFirstSubmitQcDate': '2012-07-12', 'dispFirstPostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications', 'timeFrame': '12 Months'}], 'secondaryOutcomes': [{'measure': 'Mean change in IOP from baseline', 'timeFrame': '12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Glaucoma Implant', 'Trabeculectomy', 'POAG'], 'conditions': ['Glaucoma', 'Glaucoma, Open-Angle']}, 'descriptionModule': {'briefSummary': 'To establish the safety and performance of the AqueSys Microfistula Implant in eyes with refractory glaucoma.', 'detailedDescription': 'A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys Microfistula Implant in refractory glaucoma patients who have previously failed a glaucoma procedure and who are not well-controlled on IOP lowering medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Refractory Glaucoma\n* Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg\n* Visual field mean deviation score of -3 dB or worse\n* Shaffer Angle Grade ≥ 3\n* Area of free, healthy and mobile conjunctiva in the targeted quadrant\n\nExclusion Criteria:\n\n* Active Neovascular Glaucoma\n* Previous glaucoma shunt/valve in the targeted quadrant\n* History of corneal surgery, opacities or disease/pathology\n* Anticipated need for ocular surgery\n* Non-study eye with BCVA of 20/200 or worse'}, 'identificationModule': {'nctId': 'NCT01640756', 'briefTitle': 'AqueSys Microfistula Implant in Refractory Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AqueSys, Inc.'}, 'officialTitle': 'A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys Microfistula Implant in Subjects With Refractory Glaucoma', 'orgStudyIdInfo': {'id': 'P11-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AqueSys Microfistula Implant', 'interventionNames': ['Device: AqueSys Microfistula Implant']}], 'interventions': [{'name': 'AqueSys Microfistula Implant', 'type': 'DEVICE', 'description': 'Placement of the AqueSys Microfistula Implant in the study eye', 'armGroupLabels': ['AqueSys Microfistula Implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72704', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Vold Vision, PLLC', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Eye Institute, University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06824', 'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Connecticut', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Bascom Palmer Eye Institute, University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66213', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Stiles Eyecare Excellence and Glaucoma Institute', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '55431', 'city': 'Bloomington', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Eye Consultants, PA', 'geoPoint': {'lat': 44.8408, 'lon': -93.29828}}, {'zip': '11714', 'city': 'Bethpage', 'state': 'New York', 'country': 'United States', 'facility': 'Eye Care Associates & Glaucoma Consultants of Long Island', 'geoPoint': {'lat': 40.74427, 'lon': -73.48207}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Eye and Ear Infirmary', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Eye Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texan Eye', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Glaucoma Associates of Texas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'UVA Eye Clinic, University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Spokane Eye Clinic', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Richard A Lewis, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Grutzmacher and Lewis Surgical Eye Specialists'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AqueSys, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}