Immunosuppression After Repeat Keratoplasty

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT04147390

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Keratopathy	Drug: prescribe topical 0.03 % tacrolimus Drug: prescribe mycophenolate mofetil(MMF)	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: usage mycophenolate mofetil	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
Active Comparator: usage tacrolimus	Drug: prescribe topical 0.03 % tacrolimus prescribe topical 0.03 % tacrolimus 3 times a day for 12 months

Arm

Intervention/Treatment

Active Comparator: usage mycophenolate mofetil

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

Active Comparator: usage tacrolimus

Drug: prescribe topical 0.03 % tacrolimus

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

Outcome Measures

Primary Outcome Measures

graft rejection [12 months]
clinical examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Research Center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zahra Rabbani Khah, Head of ophthalmic research center, Shahid Beheshti University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT04147390

Other Study ID Numbers:

96340

First Posted:

Nov 1, 2019

Last Update Posted:

Nov 1, 2019

Last Verified:

Oct 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mycophenolic Acid

Tacrolimus

Study Results

No Results Posted as of Nov 1, 2019