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CompletedNCT01028443Updated Dec 9, 2009

Efficacy of Topical Cyclosporine A for Treatment and Prevention of Graft Rejection in Corneal Grafts With Previous Rejection Episodes

A Phase 4 interventional study of Sandimmune and Artelose in Endothelial Graft Rejection, sponsored by Shahid Beheshti University of Medical Sciences. Completed at 2 sites in Iran, Islamic Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-12-09.

Sponsored by Shahid Beheshti University of Medical Sciences · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The use of topical Cyclosporine A early after an episode of endothelial graft rejection after penetrating keratoplasty and continuing its administration for 6 months can reduce the course of that episode and recurrence of the rejection.

02

Conditions studied

  • Endothelial Graft Rejection
03

In context

Lead sponsor

Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All

Inclusion criteria

  • Penetrating keratoplasty in eyes without vascularization

Exclusion criteria

Exclusion Criteria:

  • History of previous intraocular surgery
05

Study design

Phase
Phase 4

Study arms

  • Active comparator
    Cyclosporine A 2%

    Drug: Sandimmune

  • Placebo comparator
    Artificial tears

    Drug: Artelose

Interventions

  • DrugSandimmune
  • DrugArtelose
06

What researchers measure

Primary outcomes

  1. The rate of rejection after drop sessation

    Time frame: 3 years

07

Study locations

2 sites
  • Ophthalmic Research Center
    Tehran, 166666, Iran, Islamic Republic of
  • Ophthalmic Research Center
    Tehran, 16666, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01028443
Lead sponsor
Shahid Beheshti University of Medical Sciences
First posted
Dec 9, 2009
Last update
Dec 9, 2009
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.

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