Penetrating KeratoplastyPhase 2/3NCT00463723
Topical FK506 (Tacrolimus) for Prevention of Immune Reactions Following Penetrating Keratoplasty
A Phase 2/3 study testing FK506 0.06% (eye drops) in people with Penetrating Keratoplasty, run by University Hospital Freiburg.
Trial summary
Background: Patients following allogeneic keratoplasty are treated with topical and frequently with systemic steroids to prevent immune reactions. Steroids are known to yield good results, but exert a wide range of side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Penetrating Keratoplasty
- What is being tested?
- FK506 0.06% (eye drops)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Penetrating keratoplasty for Keratoconus
- Penetrating keratoplasty for Fuchs endothelial dystrophie
- Penetrating keratoplasty for Bullous keratopathy
Who cannot join
- Glaucoma
- Limbal stem cell deficiency
- Herpetic eye disease
- Repeat Keratoplasty
About this study
Background: Patients following allogeneic keratoplasty are treated with topical and frequently with systemic steroids to prevent immune reactions. Steroids are known to yield good results, but exert a wide range of side effects. The efficacy of topial FK506 in preventing immune reactions has already been demonstrated experimentally. FK506, an IL-2-inhibitor like Cyclosporin A (CSA), is known to be approximately 100 fold more potent than CSA. Aim of the study: In this study the efficacy and safety of topical FK506 will be compared to our standard treatment (i.e. steroids) after penetrating normal-risk keratoplasty.
- Conditions
- Penetrating Keratoplasty
- Being tested
- FK506 0.06% (eye drops)
- Keywords
- penetrating keratoplasty, graft rejection, immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FK506 0.06% (eye drops)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Penetrating KeratoplastyStudies 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
- Single blind
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- Sucampo Pharmaceuticals, Inc.
- Investigators
- Thomas Reinhard, MD, Study chair, University eye hospital Freiburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463723
- Sponsor's protocol ID
- FR-2000-2003
- Status last verified
- Aug 1999
- First submitted
- 18 Apr 2007
- Last updated
- 20 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Reinhard T, Mayweg S, Reis A, Sundmacher R. Topical FK506 as immunoprophylaxis after allogeneic penetrating normal-risk keratoplasty: a randomized clinical pilot study. Transpl Int. 2005 Feb;18(2):193-7. doi: 10.1111/j.1432-2277.2004.00006.x.
PubMed 15691272
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical FK506 (Tacrolimus) for Prevention of Immune Reactions Following Penetrating Keratoplasty
- ClinicalTrials.gov ID
- NCT00463723
- Acronym / sponsor ID
- FR-2000-2003
- Conditions
- Penetrating Keratoplasty
- Keywords
- penetrating keratoplasty, graft rejection, immunosuppression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- Sucampo Pharmaceuticals, Inc.
- First posted
- 20 Apr 2007 (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.
Background: Patients following allogeneic keratoplasty are treated with topical and frequently with systemic steroids to prevent immune reactions. Steroids are known to yield good results, but exert a wide range of side effects. The efficacy of topial FK506 in preventing immune reactions has already been demonstrated experimentally. FK506, an IL-2-inhibitor like Cyclosporin A (CSA), is known to be approximately 100 fold more potent than CSA. Aim of the study: In this study the efficacy and safety of topical FK506 will be compared to our standard treatment (i.e. steroids) after penetrating normal-risk keratoplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Penetrating keratoplasty for Keratoconus
- Penetrating keratoplasty for Fuchs endothelial dystrophie
- Penetrating keratoplasty for Bullous keratopathy
Key exclusion criteria (4 listed)
- Glaucoma
- Limbal stem cell deficiency
- Herpetic eye disease
- Repeat Keratoplasty
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 |
|---|---|---|
| FK506 0.06% (eye drops) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2007.
- Results publication: PubMed 15691272Reinhard T, Mayweg S, Reis A, Sundmacher R. Topical FK506 as immunoprophylaxis after allogeneic penetrating normal-risk keratoplasty: a randomized clinical pilot study. Transpl Int. 2005 Feb;18(2):193-7. doi: 10.1111/j.1432-2277.2004.00006.x.
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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.
Thomas Reinhard, MD study chair
University eye hospital Freiburg, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing FK506 0.06% (eye drops) in people with Penetrating Keratoplasty, run by University Hospital Freiburg.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00463723, which also lists 1 linked publication.
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 20 Apr 2007.