Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-29 @ 3:53 AM
Study NCT ID:
NCT06964061
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-03-18', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to complete biodegradation of the implant assessed by gonioscopy', 'timeFrame': 'Day 1 through study completion at least until Week 52'}], 'primaryOutcomes': [{'measure': 'Efficacy: change in mean diurnal intraocular pressure in study eye', 'timeFrame': 'Weeks 2, 12, 26 and 52'}, {'measure': 'Incidence of ocular symptoms and ocular treatment-emergent adverse events', 'timeFrame': 'Day 1 through study completion at least until Week 52', 'description': 'Ocular safety and tolerability (AEs)'}], 'secondaryOutcomes': [{'measure': 'Efficacy: intraocular pressure change from baseline in study eye at different diurnal time points.', 'timeFrame': 'Weeks 2-52'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Open Angle Glaucoma (OAG)', 'Ocular Hypertension (OH)']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to learn how effective and safe is a single administration of PA5346 Ocular Implant for the reduction of intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension. It will also assess how long it takes for PA5346 Ocular Implant to dissolve in the eye.', 'detailedDescription': 'This is an open-label study that will evaluate the efficacy, safety, tolerability and biodegradation of PA5346 Ocular Implant administered as a single dose at 115mcg in adults with open-angle glaucoma or ocular hypertension.\n\nThe study plans to recruit approximately 12 participants. Eligible participants will receive a single PA5346 Ocular Implant administered into the intracameral space of the study eye and followed for approximately 52 weeks at a minimum or until the implant is no longer visible in the study eye.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Ability to provide informed consent and follow study instructions\n* 18 years of age or older\n* Diagnosis of open-angle glaucoma or ocular hypertension in both eyes\n* Qualifying IOPs across 2 visits following washout of IOP-lowering medication, if applicable\n* Qualifying best-corrected visual acuity BCVA using Early Treatment Diabetic Retinopathy Study (ETDRS) chart in study eye\n* Qualifying corneal endothelial cell density (CEDC) in the study eye\n\nKey Exclusion Criteria:\n\n* Pseudoexfoliation or pigment dispersion, narrow irido-corneal drainage angles, or existing peripheral anterior synechiae in the inferior angle either eye.\n* Advanced or severe glaucoma\n* Disqualifying central corneal thickness in either eye\n* Significant other ocular conditions that could prevent accurate assessment of IOP and corneal health\n* Uncontrolled medical conditions\n* Have previously received, any injectable glaucoma medication into the anterior chamber of the study eye\n* Have received intravitreal injections in the study eye within the last 3 months of the Screening Visit and anticipated need for an intravitreal injection during the course of the study\n* Unwilling or unable to discontinue, in either eye, soft contact lens wear at least 2 days and hard contact lens wear 1 week before scheduled study visits and on implant administration days'}, 'identificationModule': {'nctId': 'NCT06964061', 'briefTitle': 'Evaluate Efficacy, Safety, Tolerability and Biodegradation of PA5346 Ocular Implant in Patients With Open-Angle Glaucoma or Ocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'PolyActiva Pty Ltd'}, 'officialTitle': 'An Open-label Study to Evaluate the Efficacy, Safety, Tolerability, and Biodegradation Period of PA5346 Ocular Implant, 115mcg When Administered to Patients With Open-Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'LATA-CS104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PA5436 Ocular Implant, 115mcg', 'description': 'PA5436 Ocular Implant, 115mcg administered by the Investigator into the anterior chamber of the study eye through a clear corneal injection', 'interventionNames': ['Combination Product: PA5436 Ocular Implant, 115mcg']}], 'interventions': [{'name': 'PA5436 Ocular Implant, 115mcg', 'type': 'COMBINATION_PRODUCT', 'description': 'The PA5346 Ocular Implant is supplied preloaded into the needle of a single use Administration Device ready for use.', 'armGroupLabels': ['PA5436 Ocular Implant, 115mcg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3109', 'city': 'Doncaster', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Cataract & Eye Surgery Centre', 'geoPoint': {'lat': -37.78828, 'lon': 145.12373}}, {'zip': '3002', 'city': 'East Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Marios Constantinou', 'role': 'CONTACT', 'email': 'MConstantinou@ceruleaclinicaltrials.org.au', 'phone': '+61 3 9929 8076'}], 'facility': 'Cerulea Pty Ltd', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Melbourne Eye Specialists', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'centralContacts': [{'name': 'Vanessa Waddell', 'role': 'CONTACT', 'email': 'vanessa.waddell@polyactiva.com', 'phone': '+61 3 90203565'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PolyActiva Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}