Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT05523869
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012591', 'term': 'Scleral Buckling'}], 'ancestors': [{'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-07', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-08-29', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent RRD secondary to PVR', 'timeFrame': '6 months or last follow-up'}], 'secondaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': '6 months or last follow-up'}, {'measure': 'Proliferative vitreoretinopathy grade', 'timeFrame': '6 months or last follow-up'}, {'measure': 'Retinal reattachment rate', 'timeFrame': '6 months or last follow-up'}, {'measure': 'Complications', 'timeFrame': '6 months or last follow-up'}, {'measure': 'Best corrected visual acuity change from baseline', 'timeFrame': '6 months or last follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment']}, 'descriptionModule': {'briefSummary': 'Intravitreal topotecan has anti-inflammatory, anti-proliferative and anti-fibrotic activity that we hypothesize may exhibit high efficacy for the treatment of proliferative vitreoretinopathy (PVR) in patients with rhegmatogenous retinal detachment (RRD). A high efficacy for intravitreal topotecan has been exhibited in cell cultures of PVR. At the same time, intravitreal topotecan has been routinely used in the treatment of vitreous seeds from retinoblastoma. At doses of 5-30 micrograms per injection, no adverse events have been reported with the use of intravitreal topotecan. Therefore, the current prospective matched phase II trial aims to investigate the efficacy and safety of intravitreal topotecan for severe PVR in patients with RRD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'To be enrolled, patients need to meet the following inclusion criteria:\n\n1. patients aged 18 years and older\n2. patients who undergo PPV and/or SB for recurrent RRD due to PVR\n3. patients with RRD and PVR grade C or D\n4. patients who have failed standard of care surgery for RRD in the same eye previously. In order to satisfy this inclusion criterion, patients need to have previously received at least one vitreoretinal surgery for RRD, including pneumatic retinopexy, pars plana vitrectomy and/or scleral buckle, and to have clinical documentation supporting re-detachment of the retina after one or more vitreoretinal surgeries for RRD in the same eye. This cohort of patients is expected to have an extremely guarded visual prognosis and visual potential.\n5. patients who are voluntarily able and willing to participate Patients undergoing combined phacoemulsification and PPV and/or SB will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during PPV.\n\nThe following subject exclusion criteria will be considered:\n\n1. patients with a history of tractional or exudative retinal detachment\n2. patients with severe non-proliferative or proliferative diabetic retinopathy\n3. patients with other planned ocular surgery following PPV\n4. patients with primary RRD\n5. female patients of childbearing age (i.e. less than 50 years old).\n6. patients with pre-existing bone marrow suppression or cytopenias\n7. patients with pre-existing interstitial lung disease (ILD) Any other medications or treatments, including rescue therapy, will be permitted before and/or during the trial.'}, 'identificationModule': {'nctId': 'NCT05523869', 'acronym': 'TOPO-RD', 'briefTitle': 'Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy', 'orgStudyIdInfo': {'id': 'TOPO-RD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle', 'interventionNames': ['Drug: Intravitreal topotecan', 'Procedure: Pars plana vitrectomy with or without scleral buckle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pars plana vitrectomy with or without scleral buckle', 'interventionNames': ['Procedure: Pars plana vitrectomy with or without scleral buckle']}], 'interventions': [{'name': 'Intravitreal topotecan', 'type': 'DRUG', 'description': 'Patients meeting all inclusion criteria and not meeting exclusion criteria will be assigned to receive pars plana vitrectomy with or without scleral buckle with intravitreal topotecan 8 µg/0.1mL, administered preoperatively within one week from surgery, intraoperatively during surgery, as well as postoperatively at 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks, for a total of 7 injections.', 'armGroupLabels': ['Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle']}, {'name': 'Pars plana vitrectomy with or without scleral buckle', 'type': 'PROCEDURE', 'description': 'Standard three-port pars plana vitrectomy with or without scleral buckle.', 'armGroupLabels': ['Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle', 'Pars plana vitrectomy with or without scleral buckle']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4Y 1H1', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Peter Kertes, MD', 'role': 'CONTACT', 'phone': '416-480-4244'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Rajeev Muni', 'role': 'CONTACT', 'phone': '(416) 867-7411'}], 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Rajeev Muni, MD', 'role': 'CONTACT', 'email': 'rajeev.muni@utoronto.ca', 'phone': '416-867-7411'}, {'name': 'Marko Popovic, MD', 'role': 'CONTACT', 'email': 'marko.popovic@mail.utoronto.ca', 'phone': '416-867-7411'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}