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

NCT04830878 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-04-20

No results posted yet for this study

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

DRUG

Methotrexate

Systemic and intraoperative intravitreal injection of methotrexate

Sponsors & Collaborators

Principal Investigators

  • Edward Wood, MD · Stanford University

  • Quan Dong Nguyen, MD, MSc · Stanford University

  • Ahmad Al-Moujahed, MD, PhD, MPH · Stanford University

  • Hashem Ghoraba, MD · Stanford University

  • Darius Moshfeghi, MD · Stanford University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2023-04-30
Completion
2024-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04830878 on ClinicalTrials.gov