Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT05026632
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2021-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NPI-002 Intravitreal Implant for the Delay of Cataract Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2021-08-24', 'studyFirstSubmitQcDate': '2021-08-24', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lens Densitometry', 'timeFrame': '6 months', 'description': 'Change from Baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'This study will examine the safety and efficacy NPI-002 intravitreal implants post vitrectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Indicated for vitrectomy\n2. Natural Lens in place at time of vitrectomy\n3. Some cataract present as assessed pre-operatively\n\nExclusion Criteria:\n\n1. Previous intraocular surgery in study eye.\n2. Clear zonular weakness or defects / coloboma.\n3. Not on stable dose of medications for other conditions.\n4. Need for oral corticosteroids during study participation.\n5. Evidence or history of uveitis, or ocular ischemia.\n6. Current smoker\n7. Use of supplemental oxygen\n8. Evidence or history of proliferative diabetic retinopathy.\n9. Current lung disease (PU, COPD, Asthma) resulting in decreased oxygen saturation.\n10. Sensitivity to thiol compounds.\n11. Participation in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT05026632', 'briefTitle': 'NPI-002 Intravitreal Implant for the Delay of Cataract Progression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nacuity Pharmaceuticals, Inc.'}, 'officialTitle': 'Safety and Efficacy of NPI-002 Intravitreal Implant for the Delay of Cataract Progression in Patients Undergoing Vitrectomy', 'orgStudyIdInfo': {'id': 'C-21-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single NPI-002 Intravitreal Implant', 'description': 'one NPI-002 implant inserted at the time of vitrectomy', 'interventionNames': ['Drug: NPI-002 Intravitreal Implant']}, {'type': 'EXPERIMENTAL', 'label': 'Double NPI-002 Intravitreal Implant', 'description': 'two NPI-002 implants inserted at the time of vitrectomy', 'interventionNames': ['Drug: NPI-002 Intravitreal Implant']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No implant inserted at time of vitrectomy'}], 'interventions': [{'name': 'NPI-002 Intravitreal Implant', 'type': 'DRUG', 'description': 'Implant inserted during vitrectomy.', 'armGroupLabels': ['Double NPI-002 Intravitreal Implant', 'Single NPI-002 Intravitreal Implant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adelaide', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Kylie Danise', 'role': 'CONTACT'}], 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'centralContacts': [{'name': 'Jami R Kern, PhD', 'role': 'CONTACT', 'email': 'jami@nacuity.com', 'phone': '817-291-4232'}], 'overallOfficials': [{'name': 'Jami R Kern, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nacuity Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nacuity Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}