Methotrexate For The Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Pat… (NCT04830878) | Clinical Trial Compass
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 range18 Years
SexALL
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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).
Exclusion criteria
✕. Ocular or periocular infection in either eye including (but not limited to):
✕. History of herpetic infection in the study eye(s) or adnexa.
✕. Presence of known active or inactive toxoplasmosis or toxoplasmosis scar in either eye.
✕. History of cytomegalovirus infection or clinical evidence of active cytomegalovirus infection at screening and/or Day 1.
✕. Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye(s).
✕. Media opacity that would limit clinical visualization in the study eye(s) and, in the opinion of the investigator, could not be repaired or improved during the RD surgery.
✕. Other planned eye surgery during the course of the trial
✕. Corneal opacity in the study eye(s) that would preclude reliable assessment of the posterior segment.