drugset / Trial / NCT04147390

Immunosuppression After Repeat Keratoplasty

NCT04147390

Phase 2/3 Unknown 58 enrolled Shahid Beheshti University of Medical Sciences
RandomizedParallel-groupDouble-blindPrevention

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

Timeline

Start
2019-11
Primary completion
2020-03
Completion
2020-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Mycophenolate Mofetil Small molecule 1 g Oral
Comparator Tacrolimus Small molecule 0.03 % Topical

Indications