Immunosuppression After Repeat Keratoplasty

Keratopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04147390
• Other study ID #: 96340
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 2019
• Est. completion date: August 2020

Study information

• Verified date: October 2019
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: August 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• all patients who are scheduled for repeat corneal transplantation following failed primary penetrating keratoplasty (PK )

Exclusion Criteria:

• uncontrolled increase in intraocular pressure

• active herpetic keratitis and corneal ulcer

• limbal stem cell deficiency

• a history of limbal stem cell transplantation

• age less than 18 years

• pregnancy, a history of malignant disorders

• abnormal liver or kidney function

• the presence of poorly controlled systemic hypertension

• diabetes mellitus

• systemic infections

• active peptic ulcer disease

• any gastrointestinal disorders led to patient exclusion

Related Conditions & MeSH terms

• Keratopathy

Intervention

Drug:
• prescribe topical 0.03 % tacrolimus
prescribe topical 0.03 % tacrolimus 3 times a day for 12 months
• 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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	graft rejection	clinical examination	12 months