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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01028443
First received: December 8, 2009
Last updated: NA
Last verified: April 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Endothelial Graft Rejection
Drug: Sandimmune
Drug: Artelose
Phase 4

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • The rate of rejection after drop sessation [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Arms Assigned Interventions
Active Comparator: Cyclosporine A 2% Drug: Sandimmune
Placebo Comparator: Artificial tears Drug: Artelose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Penetrating keratoplasty in eyes without vascularization

Exclusion Criteria:

  • History of previous intraocular surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028443

Locations
Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 166666
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti Medical University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01028443     History of Changes
Other Study ID Numbers: 8546
Study First Received: December 8, 2009
Last Updated: December 8, 2009
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 26, 2014