Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-29 @ 4:51 AM
Study NCT ID:
NCT05191706
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2021-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2021-12-13', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade of anterior chamber cells (ACC)', 'timeFrame': 'Post-Operative Day 14'}], 'secondaryOutcomes': [{'measure': 'Grade of anterior chamber flare (ACF)', 'timeFrame': 'Post-Operative Day 14'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'cataract'], 'conditions': ['Cataract']}, 'descriptionModule': {'briefSummary': 'A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing uncomplicated cataract surgery with or without a posterior chamber intraocular lens (IOL) implantation.\n* If a contact lens is used for correction of post-operative aphakia, it must be a silicone elastomer lens or a rigid gas permeable lens (no water content).\n* Other protocol-specified inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that could increase the risk to the subject as determined by the investigator.\n* Has a post-traumatic cataract.\n* Presence of active or suspected viral, bacterial, or fungal disease in the study eye.\n* Ocular hypertension with an IOP in the study eye \\>25 mmHg at Screening with or without treatment with anti-glaucoma monotherapy.\n* Subjects who have received a periocular corticosteroid injection in the study eye in the 3 months prior to Screening.\n* Subjects who have received any intravitreal corticosteroid delivery vehicle (eg, Retisert®, Ozurdex®, Iluvien®) in the study eye at any time.\n* Other protocol-specified exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT05191706', 'briefTitle': 'Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract', 'organization': {'class': 'INDUSTRY', 'fullName': 'EyePoint Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract', 'orgStudyIdInfo': {'id': 'EYP-DIP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DEXYCU (dexamethasoneintraocular suspension) 9%', 'description': 'A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prednisolone acetate ophthalmic suspension (USP) 1%', 'description': "Active treatment control, prednisolone acetate ophthalmic suspension (USP) 1%, four times daily (QID) for 28days, followed by a treatment taper at the investigator's discretion.", 'interventionNames': ['Drug: Prednisolone Acetate Ophthalmic']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'single anterior chamber injection', 'armGroupLabels': ['DEXYCU (dexamethasoneintraocular suspension) 9%']}, {'name': 'Prednisolone Acetate Ophthalmic', 'type': 'DRUG', 'description': 'topical administration four times a day for 28 days, followed by treatment taper', 'armGroupLabels': ['Prednisolone acetate ophthalmic suspension (USP) 1%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'EyePoint Investigational Site', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'EyePoint Investigational Site', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'EyePoint Investigative Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'EyePoint Investigational Site', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'EyePoint Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '14209', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'EyePoint Investigational Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'EyePoint Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'EyePoint Investigational Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'EyePoint Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'centralContacts': [{'name': 'Ramiro Ribeiro, MD, PhD', 'role': 'CONTACT', 'email': 'rribeiro@eyepointpharma.com', 'phone': '833-393-7646'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EyePoint Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}