NCT04147390

Immunosuppression After Repeat Keratoplasty

Topical 0.03% Tacrolimus Versus Systemic Mycophenolate Mofetil for Preventing Graft Rejection After Repeat Keratoplasty: One-year Results of a Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Purpose: To compare the efficacy of topical 0.03% tacrolimus with systemic mycophenolate mofetil (MMF) in preventing corneal allograft rejection after repeat keratoplasty. Design: Prospective, randomized clinical trial Introduction: Repeat keratoplasty continues to be an important indication for corneal transplantation in many centers, and it accounts for up to 41% (varying from 6% to 41%) of all keraptoplasty cases performed. Methods: This study will enroll all patients who are candidate for repeat keratoplasty after a failed penetrating keratoplasty. Group 1 will receive MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months, and group 2 will receive topical 0.03 % tacrolimus 3 times a day for 12 months. All patients are treated with topical and oral corticosteroids postoperatively. The participants are observed closely for signs of graft rejection, and the rates of rejection-free graft survival are calculated and compared between the two groups at postoperative month 12

Conditions

• Keratopathy

Interventions

Type	Name	Description
DRUG	prescribe topical 0.03 % tacrolimus	prescribe topical 0.03 % tacrolimus 3 times a day for 12 months
DRUG	prescribe mycophenolate mofetil(MMF)	MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months

Timeline

• Start date: 2019-11-01
• Primary completion: 2020-03-01
• Completion: 2020-08-01
• First posted: 2019-11-01
• Last updated: 2019-11-01

Locations

1 site across 1 country: Iran