Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04482543
Status:
UNKNOWN
Last Update Posted:
2020-07-22
First Post:
2020-07-18
Brief Title:
Repeated Methotrexate for Proliferative Vitreoretinopathy Grade C
Sponsor:
Shahid Beheshti University of Medical Sciences
Organization:
Shahid Beheshti University of Medical Sciences
Study Overview
Official Title:
Repeated Intra-silicone Oil Injection of Methotrexate for Management of Proliferative Vitreoretinopathy Grade C A Multi-center Study
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
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:
This multicenter randomized clinical trial evaluates the effect of multiple intra-silicone oil injections of methotrexate MTX on rhegmatogenous retinal detachment RRD with grade C proliferative vitreoretinopathy PVR
74 eyes with the diagnosis of RRD with PVR grade C will be randomized into two groups the intervention group and the control group All eyes undergo pars plana vitrectomyPPV and intraocular injection of silicone oil SO At the end of the surgical procedure intra-SO injection of 250 µg MTX will be performed in the intervention group No intra-SO injection will be done in the control group In the intervention group Intra-SO injection of MTX will be repeated at 3 and 6 weeks postoperatively Silicone oil removal will be done 3 months after surgerySpectral-domain optical coherence tomography SD-OCT image of the macula will be acquired at months 3 and 6 The retinal reattachment rate at months 6 will be assessed as the main outcome measure of the study Best corrected visual acuity retinal reproliferation rate and adverse events are the secondary outcome measures Comprehensive ocular examination will be performed at weeks 1 3 6 and at months 3 4 and 6
74 eyes with the diagnosis of RRD with PVR grade C will be randomized into two groups the intervention group and the control group All eyes undergo pars plana vitrectomyPPV and intraocular injection of silicone oil SO At the end of the surgical procedure intra-SO injection of 250 µg MTX will be performed in the intervention group No intra-SO injection will be done in the control group In the intervention group Intra-SO injection of MTX will be repeated at 3 and 6 weeks postoperatively Silicone oil removal will be done 3 months after surgerySpectral-domain optical coherence tomography SD-OCT image of the macula will be acquired at months 3 and 6 The retinal reattachment rate at months 6 will be assessed as the main outcome measure of the study Best corrected visual acuity retinal reproliferation rate and adverse events are the secondary outcome measures Comprehensive ocular examination will be performed at weeks 1 3 6 and at months 3 4 and 6
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?:
None
Is an FDA AA801 Violation?:
None