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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04830878
Other study ID # IRB-59989
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date April 2021
Est. completion date April 2024

Study information

Verified date April 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 2024
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: 1. Ability to get informed consent from a parent or a legal guardian of the child and attend all study visits. 2. Males or females 18 years old or younger. 3. 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. 4. 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. 5. 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: 1. Ocular or periocular infection in either eye including (but not limited to): 1. History of herpetic infection in the study eye(s) or adnexa. 2. Presence of known active or inactive toxoplasmosis or toxoplasmosis scar in either eye. 3. History of cytomegalovirus infection or clinical evidence of active cytomegalovirus infection at screening and/or Day 1. 2. Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye(s). 3. 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. 4. Other planned eye surgery during the course of the trial 5. Corneal opacity in the study eye(s) that would preclude reliable assessment of the posterior segment. 6. Uncontrolled glaucoma in the study eye(s), evidenced by an intraocular pressure (IOP) > 21 mmHg while on maximum medical therapy, or chronic hypotony (unmeasurable eye pressure). 7. Subjects should not be currently undergoing treatment with one of the following at the time of RD diagnosis: systemic steroids, methotrexate, azathioprine, or mycophenolate mofetil (or an equivalent drug, e.g., mycophenolic acid) or other immunomodulatory therapies. 8. Malignancy in remission for less than 5 years prior to study participation. 9. Allergy or hypersensitivity to investigational product or other study related procedures/medications. 10. Any recent systemic infection (excluding common cold) within 30 days of Day 1. 11. Known to be immunocompromised. 12. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of an investigational drug, might affect the interpretation of the results of the study, or renders the subject at high risk for treatment complications. 13. Any uncontrolled systemic disease, except stable syndromic conditions. 14. Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions (i.e., intrauterine device, oral contraceptives, barrier method, or other contraception deemed adequate by the investigator). 15. Participation in other investigational drug (oral or topical therapy) or device clinical trials within 30 days prior to Day 1 and/or participation in other investigational drug (intravitreal injection therapy) within 3 months or 5 half-lives (whichever is longer) prior to Day 1 or planning to participate in other investigational drug or device clinical trials during a time which would overlap with the duration of the study. This includes both ocular and non-ocular clinical trials. Exposure to investigational biologics should be discussed with the investigators. 16. In addition, the investigator may declare a subject ineligible for any sound reason. 17. Chest X-ray within 3 months prior to initiation of systemic MTX that shows active pulmonary diseases of any etiology.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Methotrexate
Systemic and intraoperative intravitreal injection of methotrexate

Locations

Country Name City State
United States Byers Eye Institute at Stanford University and Lucille Packard Children Hospital Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrence of Retinal Detachment Number of Participants with Recurrent Retinal Detachment 6 months
See also
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Completed NCT04891991 - Intravitreal Infliximab for Proliferative Vitreoretinopathy Phase 2
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Completed NCT00373282 - Triamcinolone Acetonide in Silicone-Filled Eyes as Adjunctive Treatment for Proliferative Vitreoretinopathy Phase 3
Completed NCT01995045 - Postoperative Pain Control Following Vitreoretinal Surgery Phase 4
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Not yet recruiting NCT06425419 - The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy Phase 1
Completed NCT02192970 - Bevacizumab Against Recurrent Retinal Detachment Phase 2
Not yet recruiting NCT04682054 - Molecular Taxonomy of Surgically-harvested Ocular Tissues Defined by Single-cell Transcriptomics N/A
Recruiting NCT05660447 - A Multi-Center Study on the Use of Rho-Kinase Inhibitor to Reduce or Prevent PVR in RRD Eyes at High Risk for PVR Phase 2/Phase 3
Not yet recruiting NCT06033703 - Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment Phase 1/Phase 2
Active, not recruiting NCT00371020 - The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR Phase 3