Corneal Graft Rejection Clinical Trial
Official title:
Evaluation of the Efficacy of 2% Cyclosporine in Preventing Graft Rejection
Aim/ Objective: Study consists of 2 separate and distinct entities A. Evaluation of the
efficacy of 2% cyclosporine in preventing graft rejection in primary grafts w/o high risk
characteristics study 1 (PKP study) B. Evaluation of the efficacy of 2% cyclosporine in
preventing graft rejection in therapeutic keratoplasty- study 2(TKP study) Materials &
Methods: In both arms Patients requiring keratoplasty, above the age of 18 whom
satisfactorily meet The inclusion criteria are different for each study Eligible candidates
will be enrolled after signing an Informed Consent form Patients will be randomized into one
of 2 groups
- Only on topical steroids group A
- On topical steroids + 2% cyclosporine Group B Study design: Prospective, randomized
non-blinded study at a single centre. Methodology In both arms
1. Schedule of topical steroid administration : 6 times for 2 weeks; 5 times for 2
weeks; 4 times for a month; 3 times for a month, and, subsequently twice-a-day until 1
year is completed Systemic steroids may be administered in the initial 2 weeks at the
discretion of the investigators. (For all patients with fungal keratitis topical
steroids can preferrably be administered only after 2 weeks post keratoplasty.) Until
then voveran ophtha may be used
3. Patients randomized to receive 2% cyclosporine will receive the same 3 times a day
for 2years
4. All patients will be followed for a minimum period of 2 years
5. Follow up schedule - at 1 week, 2 weeks, 1 month, 2 months, 3 months, then every 3
months until 2 years are completed
6. All episodes of graft rejection will be treated as per accepted norms and the
patient will no longer follow the standardized protocol for steroid administration
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05009407 -
CD160 Expression in Corneal Vessels
|
||
| Terminated |
NCT00447642 -
Study to Assess LX201 for Prevention of Corneal Allograft Rejection or Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes Following Penetrating Keratoplasty
|
Phase 3 |