KeratopathyPhase 2/3NCT04147390
Immunosuppression After Repeat Keratoplasty
A Phase 2/3 study testing prescribe topical 0.03 % tacrolimus and prescribe mycophenolate mofetil(MMF) in people with Keratopathy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Purpose: To compare the efficacy of topical 0.03% tacrolimus with systemic mycophenolate mofetil (MMF) in preventing corneal allograft rejection after repeat keratoplasty. Design: Prospective, randomized clinical trial Introduction: Repeat keratoplasty continues to be an important indication for corneal… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratopathy
- What is being tested?
- prescribe topical 0.03 % tacrolimus and prescribe mycophenolate mofetil(MMF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteIran
- Study dates
- Nov 2019to Aug 2020
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients who are scheduled for repeat corneal transplantation following failed primary penetrating keratoplasty (PK )
Who cannot join
- uncontrolled increase in intraocular pressure
- active herpetic keratitis and corneal ulcer
- limbal stem cell deficiency
- a history of limbal stem cell transplantation
- age less than 18 years
- pregnancy, a history of malignant disorders
Show all 12Show fewer
- abnormal liver or kidney function
- the presence of poorly controlled systemic hypertension
- diabetes mellitus
- systemic infections
- active peptic ulcer disease
- any gastrointestinal disorders led to patient exclusion
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
Amir Faramarzi, MD, 009822591616, labbafi@hotmail.com
About this study
Official title: Topical 0.03% Tacrolimus Versus Systemic Mycophenolate Mofetil for Preventing Graft Rejection After Repeat Keratoplasty: One-year Results of a Randomized Clinical Trial
Purpose: To compare the efficacy of topical 0.03% tacrolimus with systemic mycophenolate mofetil (MMF) in preventing corneal allograft rejection after repeat keratoplasty.
Design: Prospective, randomized clinical trial Introduction: Repeat keratoplasty continues to be an important indication for corneal transplantation in many centers, and it accounts for up to 41% (varying from 6% to 41%) of all keraptoplasty cases performed.
Methods: This study will enroll all patients who are candidate for repeat keratoplasty after a failed penetrating keratoplasty. Group 1 will receive MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months, and group 2 will receive topical 0.03 % tacrolimus 3 times a day for 12 months. All patients are treated with topical and oral corticosteroids postoperatively. The participants are observed closely for signs of graft rejection, and the rates of rejection-free graft survival are calculated and compared between the two groups at postoperative month 12
- Conditions
- Keratopathy
- Being tested
- prescribe topical 0.03 % tacrolimus, prescribe mycophenolate mofetil(MMF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prescribe topical 0.03 % tacrolimusDrug
prescribe topical 0.03 % tacrolimus 3 times a day for 12 months
prescribe mycophenolate mofetil(MMF)Drug
MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months
| Study group | Role | What they receive |
|---|---|---|
| usage mycophenolate mofetil | Active comparator | Not described Receives: Drug: prescribe mycophenolate mofetil(MMF) |
| usage tacrolimus | Active comparator | Not described Receives: Drug: prescribe topical 0.03 % tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft rejection
clinical examination
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratopathyStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147390
- Sponsor's protocol ID
- 96340
- Status last verified
- Oct 2019
- First submitted
- 30 Oct 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical 0.03% Tacrolimus Versus Systemic Mycophenolate Mofetil for Preventing Graft Rejection After Repeat Keratoplasty: One-year Results of a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04147390
- Acronym / sponsor ID
- 96340
- Conditions
- Keratopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 1 Nov 2019 (actual)
- 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.
Purpose: To compare the efficacy of topical 0.03% tacrolimus with systemic mycophenolate mofetil (MMF) in preventing corneal allograft rejection after repeat keratoplasty.
Design: Prospective, randomized clinical trial Introduction: Repeat keratoplasty continues to be an important indication for corneal transplantation in many centers, and it accounts for up to 41% (varying from 6% to 41%) of all keraptoplasty cases performed.
Methods: This study will enroll all patients who are candidate for repeat keratoplasty after a failed penetrating keratoplasty. Group 1 will receive MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months, and group 2 will receive topical 0.03 % tacrolimus 3 times a day for 12 months. All patients are treated with topical and oral corticosteroids postoperatively. The participants are observed closely for signs of graft rejection, and the rates of rejection-free graft survival are calculated and compared between the two groups at postoperative month 12
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usage mycophenolate mofetil | Active comparator | Drug: prescribe mycophenolate mofetil(MMF) |
| usage tacrolimus | Active comparator | Drug: prescribe topical 0.03 % tacrolimus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients who are scheduled for repeat corneal transplantation following failed primary penetrating keratoplasty (PK )
Key exclusion criteria (12 listed)
- uncontrolled increase in intraocular pressure
- active herpetic keratitis and corneal ulcer
- limbal stem cell deficiency
- a history of limbal stem cell transplantation
- age less than 18 years
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 |
|---|---|---|
| prescribe topical 0.03 % tacrolimusprescribe topical 0.03 % tacrolimus 3 times a day for 12 months | Drug | usage tacrolimus |
| prescribe mycophenolate mofetil(MMF)MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months | Drug | usage mycophenolate mofetil |
Primary outcome
graft rejection
Time frame: 12 months
clinical examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing prescribe topical 0.03 % tacrolimus and prescribe mycophenolate mofetil(MMF) in people with Keratopathy, run by Shahid Beheshti University of Medical Sciences at 1 site 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 12 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: status not confirmed, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
graft rejection (time frame: 12 months). 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 1 Nov 2019.