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
1 other identifier
interventional
58
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2019
CompletedFirst Posted
Study publicly available on registry
November 1, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedNovember 1, 2019
October 1, 2019
4 months
October 30, 2019
October 30, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
graft rejection
clinical examination
12 months
Study Arms (2)
usage mycophenolate mofetil
ACTIVE COMPARATORusage tacrolimus
ACTIVE COMPARATORInterventions
prescribe topical 0.03 % tacrolimus 3 times a day for 12 months
MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months
Eligibility Criteria
You may qualify if:
- all patients who are scheduled for repeat corneal transplantation following failed primary penetrating keratoplasty (PK )
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmic Research Center
Tehran, Iran
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of ophthalmic research center
Study Record Dates
First Submitted
October 30, 2019
First Posted
November 1, 2019
Study Start
November 1, 2019
Primary Completion
March 1, 2020
Study Completion
August 1, 2020
Last Updated
November 1, 2019
Record last verified: 2019-10