Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425419
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-01-09
Brief Title:
The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy
Sponsor:
Massachusetts Eye and Ear Infirmary
Organization:
Massachusetts Eye and Ear Infirmary
Study Overview
Official Title:
The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The goal of this clinical trial is to evaluate the safety and efficacy of intravitreal topotecan for the treatment of patients with rhegmatogenous retinal detachment due to proliferative vitreoretinopathy PVR or resulting from an open globe injury and compare the outcomes to those who do no receive intravitreal topotecan The main objectives it aims to achieve are
to study the safety profile of intravitreal topotecan in the treatment of PVR
to evaluate the efficacy of intravitreal topotecan in treating PVR
Post-consent participants will
undergo vitrectomy with or without scleral buckle as part of standard treatment for retinal detachment
receive intravitreal topotecan at the time of surgery post-operative day 7 and post-operative day 28 if randomized to receive the medication
come in at post-operative day 1 7 28 56 84 126 and 168 to undergo a complete ophthalmic exam along with a fundus photography and optical coherence tomography of the macula have their intraocular pressure and visual acuity measured and their adverse events monitored if any
Researchers will compare participants who receive intravitreal topotecan for PVR to those who do not to see if there is a significant variability in recurrence of retinal detachment rate of retinal reattachment and PVR grade 6 months after surgery
to study the safety profile of intravitreal topotecan in the treatment of PVR
to evaluate the efficacy of intravitreal topotecan in treating PVR
Post-consent participants will
undergo vitrectomy with or without scleral buckle as part of standard treatment for retinal detachment
receive intravitreal topotecan at the time of surgery post-operative day 7 and post-operative day 28 if randomized to receive the medication
come in at post-operative day 1 7 28 56 84 126 and 168 to undergo a complete ophthalmic exam along with a fundus photography and optical coherence tomography of the macula have their intraocular pressure and visual acuity measured and their adverse events monitored if any
Researchers will compare participants who receive intravitreal topotecan for PVR to those who do not to see if there is a significant variability in recurrence of retinal detachment rate of retinal reattachment and PVR grade 6 months after surgery
Detailed Description:
Rhegmatogenous retinal detachment RRD is an acute sight-threatening condition that occurs after separation of the neurosensory retina from the underlying retinal pigment epithelium RPE due to the presence of a retinal break Proliferative vitreoretinopathy PVR represents growth of ectopic fibrocellular growth on the surface of within and underneath the retina PVR is hypothesized to occur secondary to the migration of RPE cells to the peri-retina leading to a mesenchymal transition into contractile myofibroblasts PVR affects 5-10 of RRDs and is the most common cause of surgical failure in RRD
Given that PVR involves a pro-inflammatory and pro-fibrotic cellular response adjuvants such as corticosteroids and antimetabolites such as 5-fluorouracil have been attempted in the treatment of this condition Overall the efficacy results of these treatments have been mixed and no standard of care adjuvant therapy has emerged
Topotecan is a chemotherapeutic agent that acts as a topoisomerase inhibitor It is most commonly administered intravitreally for patients with refractory or recurrent vitreous seeds from retinoblastoma and shows high efficacy in this setting At the same time intravitreal topotecan administered at doses of 5-30µg has been associated with no ocular or systemic complications or adverse electroretinogram changes To the best of available knowledge topotecan has not been administered for the treatment of proliferative vitreoretinopathy Topotecan has anti-inflammatory anti-proliferative and anti-fibrotic activity that is hypothesized to exhibit high efficacy for the treatment of PVR In this study the efficacy and safety of intravitreal topotecan for the treatment of PVR will be investigated
Given that PVR involves a pro-inflammatory and pro-fibrotic cellular response adjuvants such as corticosteroids and antimetabolites such as 5-fluorouracil have been attempted in the treatment of this condition Overall the efficacy results of these treatments have been mixed and no standard of care adjuvant therapy has emerged
Topotecan is a chemotherapeutic agent that acts as a topoisomerase inhibitor It is most commonly administered intravitreally for patients with refractory or recurrent vitreous seeds from retinoblastoma and shows high efficacy in this setting At the same time intravitreal topotecan administered at doses of 5-30µg has been associated with no ocular or systemic complications or adverse electroretinogram changes To the best of available knowledge topotecan has not been administered for the treatment of proliferative vitreoretinopathy Topotecan has anti-inflammatory anti-proliferative and anti-fibrotic activity that is hypothesized to exhibit high efficacy for the treatment of PVR In this study the efficacy and safety of intravitreal topotecan for the treatment of PVR will be investigated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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