Endothelial Graft RejectionPhase 4NCT01028443
Efficacy of Topical Cyclosporine A for Treatment and Prevention of Graft Rejection in Corneal Grafts With Previous Rejection Episodes
A Phase 4 study testing Sandimmune and Artelose in people with Endothelial Graft Rejection, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Endothelial Graft Rejection
- What is being tested?
- Sandimmune and Artelose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 2 sitesIran
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Penetrating keratoplasty in eyes without vascularization
Who cannot join
- History of previous intraocular surgery
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Ophthalmic Research Center
Tehran, Tehran Province, 166666
Ophthalmic Research Center
Tehran, Tehran Province, 16666
About this study
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.
- Conditions
- Endothelial Graft Rejection
- Being tested
- Sandimmune, Artelose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SandimmuneDrug
ArteloseDrug
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine A 2% | Active comparator | Not described Receives: Drug: Sandimmune |
| Artificial tears | Placebo comparator | Not described Receives: Drug: Artelose |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of rejection after drop sessation
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial Graft RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028443
- Sponsor's protocol ID
- 8546
- Status last verified
- Apr 2006
- First submitted
- 8 Dec 2009
- Last updated
- 9 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Cyclosporine A for Treatment and Prevention of Graft Rejection in Corneal Grafts With Previous Rejection Episodes
- ClinicalTrials.gov ID
- NCT01028443
- Acronym / sponsor ID
- 8546
- Conditions
- Endothelial Graft Rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine A 2% | Active comparator | Drug: Sandimmune |
| Artificial tears | Placebo comparator | Drug: Artelose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Penetrating keratoplasty in eyes without vascularization
Key exclusion criteria (1 listed)
- History of previous intraocular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sandimmune | Drug | Cyclosporine A 2% |
| Artelose | Drug | Artificial tears |
Primary outcome
The rate of rejection after drop sessation
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sandimmune and Artelose in people with Endothelial Graft Rejection, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of rejection after drop sessation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2009.