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A prospective, open-label, parallel-controlled study for the efficacy and safety of mycophenolate mofetil in the prevention and treatment of high-risk corneal allograft

A prospective, open-label, parallel-controlled study for the efficacy and safety of mycophenolate mofetil in the prevention and treatment of high-risk corneal allograft

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026319
Enrollment
Unknown
Registered
2019-09-29
Start date
2019-10-08
Completion date
Unknown
Last updated
2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-risk corneal transplant

Interventions

Experimental group:Mycophenolate dispersible tablets,Other medications are consistent with the control regimen
control group:1) Postoperative administration of glucocorticoid eye drops 2) Combined tacrolimus eye drops after surgery 3) Artificial tears can be administered at any time 4) Use of antibiotics as ap

Sponsors

Beijing Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Subjects should meet the following criteria in order to participate in this study. Identifying high-risk corneal transplant recipients (any of the following criteria) can be included in the case; 1) Corneal leukoplakia combined with neovascularization or pre-iris adhesion; 2) corneal leukoplakia after burns (acid, alkali, heat); 3) Two or more corneal retransplantation; 4) Plant bed >= 9.0mm; 5) Corneal transplantation combined with vitrectomy; 6) Penetrating keratoplasty during inflammatory phase or bacterial infection of corneal ulcer or perforation; 7) 3 to 4 quadrants of corneal implants showing superficial or deep neovascularization; 8) Active recurrent or chronic uveitis; immunogenic grafts with severe atopic dermatitis and steroid-responsive glaucoma. 9)Aged 18-70 years; 10) Informed consent can be signed and the agreed timetable for this study can be observed.

Exclusion criteria

Exclusion criteria: Objects may not participate in research if they have one of the following conditions: 1) There is reason to suspect that the patient was forced to join the trial; 2) The patient has severe cardiovascular and cerebrovascular diseases; severe organic diseases such as liver and kidney dysfunction; 3) Other clinically considered not suitable for this treatment; 4) Other malignant diseases such as acute or chronic systemic infection, peptic ulcer disease, and malignant blood diseases; 5) Those who are allergic or intolerant to MMF, CsA immunosuppressive agents or who have a history of allergies; 6) Pregnant women or those who are preparing for pregnancy or neurological diseases and language dysfunction; 7) Those who took immunosuppressives 3 months before enrollment.

Design outcomes

Primary

MeasureTime frame
Rejection rate and time of occurrence within 1 year;

Secondary

MeasureTime frame
vision;Pharmacoeconomic evaluation;

Countries

China

Contacts

Public ContactZhiqiang Pan

Beijing Tongren Hospital, Capital Medical University

Panyj0526@sina.com+86 13911799840

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026