Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT04501367
Status:
UNKNOWN
Last Update Posted:
2023-06-29
First Post:
2020-07-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019773', 'term': 'Epiretinal Membrane'}, {'id': 'D010211', 'term': 'Papilledema'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In patients who undergo vitrectomy with internal limiting membrane peel surgery , subjects will be randomized to three groups and be followed for a period of two months. One group will be selected to receive one DEXTENZA (in the lower canaliculus), the second group will receive two DEXTENZA (upper and lower canaliculi) and the third group will receive prednisolone acetate 1% (control eye) . All groups will receive a subconjunctival dexamethasone injection at the time of surgery.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in retina edema', 'timeFrame': 'assessed on day 30 and day 60', 'description': 'As measured by Optical Coherence Tomography (OCT)'}], 'secondaryOutcomes': [{'measure': 'Mean change in Inflammation ( Cell and Flare)', 'timeFrame': 'as assessed on days 1, 7, 30, 60', 'description': 'As measured by SUN (Standardization of Uveitis Nomenclature) grading scale;absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of 0-1'}, {'measure': 'Mean change in pain scores', 'timeFrame': 'as assessed on days 1, 7, 30, 60', 'description': 'as measured with the visual analog scale (VAS); between 0 and 10; 0 meaning no pain and 10 meaning worst pain possible'}, {'measure': 'Mean Change in Best- Corrected Visual Acuity (BCVA)', 'timeFrame': 'from baseline at days 1, 7, 30, 60', 'description': 'as measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart'}, {'measure': 'Physician ease of Dextenza insertion', 'timeFrame': 'as assessed on day of surgery', 'description': 'measured by a 0-10 scale'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitrectomy', 'Macular Pucker', 'Retinal Edema']}, 'descriptionModule': {'briefSummary': 'Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel', 'detailedDescription': 'Assessing the efficacy and safety of DEXTENZA, sustained release dexamethasone 0.4 mg inserts, when placed within the lower eye lid canaliculus or both the upper and lower canaliculi for the treatment of pain, inflammation, and cystoid macular edema following 27 gauge vitrectomy with internal limiting membrane peel for the treatment of retinal edema associated with macular pucker'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: A patient's study eye must meet the following criteria to be eligible for inclusion in the study:\n\n* Symptomatic macular pucker with retinal edema\n* Age 18 years and older\n* Scheduled vitrectomy and internal limiting membrane peel\n* Willing and able to comply with clinic visits and study related procedures\n* Willing and able to sign the informed consent form\n\nExclusion Criteria: A patient who meets any of the following criteria will be excluded from the study:\n\n* Patients under the age of 18\n* Pregnancy ( must be ruled out in women of child-bearing age with pregnancy test)\n* Active infectious systemic disease\n* Active infectious ocular or extraocular disease\n* Obstructed nasolacrimal duct in the study eye (s)\n* Hypersensitivity to dexamethasone or prednisolone eye drops\n* Patients being treated with immunomodulating agents in the study eye(s)\n* Patient being treated with immunosuppressants and/or oral steroids\n* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator"}, 'identificationModule': {'nctId': 'NCT04501367', 'briefTitle': 'Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kovach Eye Institute'}, 'officialTitle': 'Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) When Placed Within the Lower Eye Lid Canaliculus or Both the Upper and Lower Canaliculi for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.', 'orgStudyIdInfo': {'id': 'Kovacheye'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DEXTENZA Group', 'description': 'Patients undergoing vitrectomy with internal limiting membrane peel', 'interventionNames': ['Drug: Dexamethasone Intracanalicular Insert, 0.4 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Second DEXTENZA Group', 'description': 'Patients undergoing vitrectomy with internal limiting membrane peel', 'interventionNames': ['Drug: Dexamethasone Intracanalicular Insert, 0.4 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Topical Prednisolone Acetate 1% Group', 'description': 'Patients undergoing vitrectomy with internal limiting membrane peel', 'interventionNames': ['Drug: Prednisone acetate 1%']}], 'interventions': [{'name': 'Dexamethasone Intracanalicular Insert, 0.4 mg', 'type': 'DRUG', 'description': 'To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery', 'armGroupLabels': ['DEXTENZA Group']}, {'name': 'Dexamethasone Intracanalicular Insert, 0.4 mg', 'type': 'DRUG', 'description': 'To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with two DEXTENZA (upper and lower canaliculi) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery', 'armGroupLabels': ['Second DEXTENZA Group']}, {'name': 'Prednisone acetate 1%', 'type': 'DRUG', 'description': 'To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery', 'armGroupLabels': ['Topical Prednisolone Acetate 1% Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60126', 'city': 'Elmhurst', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jamie White, BA', 'role': 'CONTACT', 'email': 'jamie.white@kovacheye.com', 'phone': '630-833-9361', 'phoneExt': '129'}, {'name': 'Saad Ahmad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kovach Eye Institute', 'geoPoint': {'lat': 41.89947, 'lon': -87.94034}}], 'centralContacts': [{'name': 'Saad Ahmad, MD', 'role': 'CONTACT', 'email': 'ifixretinas@gmail.com', 'phone': '6308339361'}, {'name': 'Jamie White, Bachelors', 'role': 'CONTACT', 'email': 'jamie.white@kovacheye.com', 'phone': '6308339621'}], 'overallOfficials': [{'name': 'Saad Ahmad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kovach Eye Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kovach Eye Institute', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}