NCT04830878

Methotrexate For The Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Proliferative Vitreoretinopathy

Interventions

Type	Name	Description
DRUG	Methotrexate	Systemic and intraoperative intravitreal injection of methotrexate

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-04-01
• Completion: 2024-04-01
• First posted: 2021-04-05
• Last updated: 2023-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study