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:
Shaheed Beheshti Medical University
Information provided by:
Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01028443
First received: December 8, 2009
Last updated: NA
Last verified: April 2006
History: No changes posted
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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 Shaheed 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
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
Shaheed 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 May 16, 2013