WithdrawnPhase 1

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

Stopped: Lack of funding

United States0Started 2021-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Ability to get informed consent from a parent or a legal guardian of the child and attend all study visits.
. Males or females 18 years old or younger.
. Subject is undergoing vitrectomy for either i. initial retinal detachment with or without PVR ii. recurrent retinal detachment due to grade A or higher of proliferative vitreoretinopathy.
. Female subjects of childbearing potential must not be pregnant or breast-feeding, must have a negative serum pregnancy test at screening, and must be willing to undergo pregnancy tests throughout the study.
. Female subjects of childbearing potential and male subjects able to father children must (a) abstain from intercourse throughout the course of the study or (b) agree to practice acceptable methods of contraception throughout the course of the study (i.e., intrauterine device, oral contraceptives, barrier method, or other contraception deemed adequate by the investigator).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recurrence of Retinal Detachment

Timeframe: 6 months

Trial details

NCT IDNCT04830878

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04

View on ClinicalTrials.gov More Proliferative Vitreoretinopathy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Ability to get informed consent from a parent or a legal guardian of the child and attend all study visits.
. Males or females 18 years old or younger.
. Subject is undergoing vitrectomy for either i. initial retinal detachment with or without PVR ii. recurrent retinal detachment due to grade A or higher of proliferative vitreoretinopathy.
. Female subjects of childbearing potential must not be pregnant or breast-feeding, must have a negative serum pregnancy test at screening, and must be willing to undergo pregnancy tests throughout the study.
. Female subjects of childbearing potential and male subjects able to father children must (a) abstain from intercourse throughout the course of the study or (b) agree to practice acceptable methods of contraception throughout the course of the study (i.e., intrauterine device, oral contraceptives, barrier method, or other contraception deemed adequate by the investigator).

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria