Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-03-03 @ 4:29 AM
Study NCT ID:
NCT03604328
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2018-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2018-07-10', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as measured by the occurrence of adverse events', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Timeframe to complete implant biodegradation based on implant size and location', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Open-angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'A single centre, open label, study to assess the safety, tolerability and biodegradation of PA5108 ocular implant in adults who have Open Angle Glaucoma (Primary or Secondary).', 'detailedDescription': 'Participants who are currently managing their Open Angle Glaucoma with combination drop therapy will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive via injection, a single PA5108 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Grade 3 or 4 open angle glaucoma (Shaffer-Etienne scale)\n* Visual acuity in non-study eye same or better than study eye\n* Currently taking topical ocular hypotensive medication including a prostaglandin analogue\n\nExclusion Criteria:\n\n* Aphakic eyes\n* Only one eye\n* History of, or current uveitis, Cystoid Macular Edema (CME) or cornea edema\n* Intraocular surgery or cornea/refractive surgery in study eye in past 6 months or anticipate need for eye surgery (including laser) in study eye during study period\n* Current retinal detachment\n* Uncontrolled infection in the eye'}, 'identificationModule': {'nctId': 'NCT03604328', 'briefTitle': 'Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'PolyActiva Pty Ltd'}, 'officialTitle': 'An Open-label Phase I Study to Evaluate the Safety, Tolerability and Biodegradation Period of PolyActiva PA5108 Ocular Implant When Administered Intracamerally to the Anterior Chamber of the Eye', 'orgStudyIdInfo': {'id': 'LATA-CS101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PA5108', 'description': 'PA5108 ocular implant (study eye) and topical prostaglandin analogue therapy (non-study eye)', 'interventionNames': ['Drug: PA5108']}], 'interventions': [{'name': 'PA5108', 'type': 'DRUG', 'description': 'single ocular implant, administered on day 1', 'armGroupLabels': ['PA5108']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Centre for Eye Research Australia', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Melbourne Eye Specialists', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Nathan Kerr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Royal Victorian Eye & Ear Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PolyActiva Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}