Methotrexate For The Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients
NCT04830878 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2023-04-20
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
- lead OTHER
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
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