Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04830878
Status:
WITHDRAWN
Last Update Posted:
2023-04-20
First Post:
2021-03-31
Brief Title:
Methotrexate For The Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Phase I Multicenter Uncontrolled Open Label Study Assessing the Efficacy and Safety of a Combination of Systemic and Intravitreal Injections of Methotrexate for the Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients With RheGmatogenous Retinal DetacHmenT the SIGHT Study
Status:
WITHDRAWN
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIGHT
Brief Summary:
Rhegmatogenous retinal detachment RRD is a sight-threatening condition Children with RRD usually present late with clinical features of longstanding RRD specifically a serious condition named proliferative vitreoretinopathy PVR Therefore children with RRD often have poorer outcomes The objective of this study is to investigate the efficacy and safety of methotrexate in the treatment and prevention of PVR Methotrexate is a medication that has been used to treat inflammatory conditions in children and adults for a long time and it has been recently used to treat PVR in adults
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None