Ignite Creation Date:
2024-05-06 @ 6:03 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05523869
Status:
RECRUITING
Last Update Posted:
2023-03-02
First Post:
2022-08-29
Brief Title:
Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment With Proliferative Vitreoretinopathy
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment With Proliferative Vitreoretinopathy
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOPO-RD
Brief Summary:
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None