Corneal TransplantationPhase 3NCT00447642
Study to Assess LX201 for Prevention of Corneal Allograft Rejection or Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes Following Penetrating Keratoplasty
A Phase 3 study testing LX201 in people with Corneal Transplantation and Corneal Graft Rejection, run by Lux Biosciences, Inc. at 30 sites in 2 countries.
Trial summary
This study will evaluate the use of LX201 to prevent future graft rejection episodes and/or graft failure in patients who have undergone corneal transplantation and who have recently experienced a rejection episode due to an immune response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Transplantation, Corneal Graft Rejection
- What is being tested?
- LX201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 30 sitesin 2 countries
- Study dates
- Apr 2007to Jan 2010
- Phase
- Phase 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
- Subjects who, within 6 months prior to study randomization, have experienced 1 or more corneal allograft rejection episodes following penetrating keratoplasty
- Must be on a stable medical regimen for at least 14 days at the time of randomization into the study
- Conjunctiva must be suitable for implantation with the study device
Who cannot join
- Any condition that would greatly increase the risk of non-rejection graft failure such as Stevens-Johnson syndrome, xerophthalmia or severe exposure keratitis.
- Schirmer's test ≤ 5 mm in 1 minute.
- Clinical evidence of limbal stem cell deficiency.
- History of or active herpes simplex virus keratitis or other acute corneal infection
- Subjects who have had > 3 failed grafts in the ipsilateral eye
- Uncontrolled glaucoma as evidenced by an intraocular pressure of > 21 mmHg while on maximal medical therapy
Show all 21Show fewer
- Clinically suspected or confirmed ocular lymphoma
- Treatment with a systemic immunosuppressive regimen within the previous 30 days; systemic prednisone (or its equivalent) of ≤ 10 mg daily is, however, permitted.
- Any implantable corticosteroid-eluting device (e.g., Retisert™, Posurdex®, Medidur™, I-vation™ triamcinolone acetonide [TA] intravitreal implant)
- Subjects who periodically require high-dose systemic steroid treatment (e.g., for exacerbation of chronic obstructive pulmonary disease).
- Subjects who have received treatment with a monoclonal antibody or any other biologic therapy within the previous 90 days or alemtuzumab within the previous 12 months
- History of herpes zoster or varicella infection within 6 weeks prior to enrollment, or chicken pox exposure within 21 days before enrollment
- Seropositivity for human immunodeficiency virus (HIV)
- Previous exposure or known contraindication to administration of cyclosporine
- Recipients of a solid organ transplant
- Currently participating in another clinical trial with an investigational agent in the 30 days prior to study participation and/or has not recovered from any reversible effects or side effects of prior investigational agent
- Currently pregnant or lactating
- Active, extraocular and/or systemic infection requiring the prolonged or chronic use of antimicrobial agents or the presence of active hepatitis A, B or C
- Current malignancy or a history of malignancy (within the previous 5 years) except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix that has been treated successfully
- Active peptic ulcer disease
- Co-morbid conditions that require immunosuppression
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States24 sites
W.K. Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan, 48105
Emory Eye Center
Atlanta, Georgia, 30322
The Eye Center at Union Memorial Hospital
Baltimore, Maryland, 21218
Wilmer Eye Institute, Cornea Service
Baltimore, Maryland, 21287
MN Eye Consultants, P.A.
Bloomington, Minnesota, 55431
New England Eye Center
Boston, Massachusetts, 02111
University of Illinois at Chicago
Chicago, Illinois, 60612
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Cornea Associates of Texas
Dallas, Texas, 75231
Duke University Eye Center
Durham, North Carolina, 27705
Price Vision Group
Indianapolis, Indiana, 46260
Tauber Eye Center
Kansas City, Missouri, 64111
Loma Linda University Health Care
Loma Linda, California, 92354
USC Doheny Eye Institute
Los Angeles, California, 90033
Bascom Palmer Eye Institute
Miami, Florida, 33136
New York Eye and Ear Infirmary
New York, New York, 10003
Mount Sinai School of Medicine
New York, New York, 10029
UMDNJ - New Jersey Medical School Institute of Ophthalmology and Visual Science
Newark, New Jersey, 07103
Virginia Eye Consultants
Norfolk, Virginia, 23502
Cornea Consultants of Arizona
Phoenix, Arizona, 85032
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570
Eye Associates NW
Seattle, Washington, 98104
Cornea Consultants of Albany
Slingerlands, New York, 12159
Ophthalmology Associates
St Louis, Missouri, 63141
Germany6 sites
Augenklinik, Universitat Erlangen-Nurnberg
Erlangen, 91054
Cornea Bank, Universitätsklinikum Essen
Essen, 45122
Klinik fuer Ophthalmologie Campus Kiel
Kiel, 24105
Ludwig Maximilians Universität
München, 80336
Augenklinik der Technischen Universität München
München, 81675
Augenklinik Wuerzburg
Würzburg, 97080
About this study
Official title: A Multi-center, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Assess the Efficacy and Safety of LX201 Implantation for the Prevention of Corneal Allograft Rejection Episodes or Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes Following Penetrating Keratoplasty
This study will evaluate the use of LX201 to prevent future graft rejection episodes and/or graft failure in patients who have undergone corneal transplantation and who have recently experienced a rejection episode due to an immune response.
Read the detailed description
LX201 was a novel sustained-release silicone implant containing 30% cyclosporine A by weight. LX201 is intended for surgical episcleral placement in the eye.
The study was a Phase 2/3, multi-center, placebo-controlled, randomized, parallel-group, dose-ranging study of LX201 for prevention of corneal allograft rejection or graft failure in subjects who have had one or more rejection episodes following penetrating keratoplasty.
After Visit 12 (Week 52), subjects in the USA and India with the implant in the study eye were to be followed for safety at least once per year for a 2 year period or until time of implant removal. In Germany, the implant was to be removed at Week 52 with a 3-month safety follow-up period after removal.
- Conditions
- Corneal Transplantation, Corneal Graft Rejection
- Being tested
- LX201, Placebo
- Keywords
- immunology, cornea, allograft, corneal allograft rejection, graft failure
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX201Drug
LX201 was a novel sustained-release silicone implant containing 30% cyclosporine A by weight.
LX201 was available in two different lengths, 0.50 and 0.75 inch. Each implant is 0.08 inch wide and 0.04 inch in height. The implants are flat on one side (the posterior surface, which is applied to the episclera) and the anterior surface and ends were rounded.
PlaceboOther
The placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A
| Study group | Role | What they receive |
|---|---|---|
| LX201 0.50 inch implant | Experimental | LX201 implant contained 30% cyclosporine A by weight and 0.50 inch in length Receives: Drug: LX201 |
| LX201 0.75 inch implant | Experimental | LX201 implant contained 30% cyclosporine A by weight and 0.75 inch by length Receives: Drug: LX201 |
| Placebo 0.75 inch implant | Placebo comparator | Silicone implant not containing cyclosporine A, 0.75 inch in length Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of corneal allograft rejection or graft failure
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionAug 2008
- Study completionJan 2010
Why it stopped: The primary efficacy endpoint was not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TransplantationStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lux Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eddy Anglade, MD, Study chair, Chief Medical Officer, Lux Biosciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447642
- Sponsor's protocol ID
- LX201-02
- Status last verified
- Oct 2012
- First submitted
- 13 Mar 2007
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Placebo-Controlled, Randomized, Parallel-Group, Dose-Ranging Study to Assess the Efficacy and Safety of LX201 Implantation for the Prevention of Corneal Allograft Rejection Episodes or Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes Following Penetrating Keratoplasty
- ClinicalTrials.gov ID
- NCT00447642
- Acronym / sponsor ID
- LX201-02
- Conditions
- Corneal Transplantation, Corneal Graft Rejection
- Keywords
- immunology, cornea, allograft, corneal allograft rejection, graft failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The primary efficacy endpoint was not met
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Lux Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 15 Mar 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.
This study will evaluate the use of LX201 to prevent future graft rejection episodes and/or graft failure in patients who have undergone corneal transplantation and who have recently experienced a rejection episode due to an immune response.
Detailed description
LX201 was a novel sustained-release silicone implant containing 30% cyclosporine A by weight. LX201 is intended for surgical episcleral placement in the eye.
The study was a Phase 2/3, multi-center, placebo-controlled, randomized, parallel-group, dose-ranging study of LX201 for prevention of corneal allograft rejection or graft failure in subjects who have had one or more rejection episodes following penetrating keratoplasty.
After Visit 12 (Week 52), subjects in the USA and India with the implant in the study eye were to be followed for safety at least once per year for a 2 year period or until time of implant removal. In Germany, the implant was to be removed at Week 52 with a 3-month safety follow-up period after removal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LX201 0.50 inch implant | Experimental | Drug: LX201LX201 implant contained 30% cyclosporine A by weight and 0.50 inch in length |
| LX201 0.75 inch implant | Experimental | Drug: LX201LX201 implant contained 30% cyclosporine A by weight and 0.75 inch by length |
| Placebo 0.75 inch implant | Placebo comparator | Other: PlaceboSilicone implant not containing cyclosporine A, 0.75 inch in length |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who, within 6 months prior to study randomization, have experienced 1 or more corneal allograft rejection episodes following penetrating keratoplasty
- Must be on a stable medical regimen for at least 14 days at the time of randomization into the study
- Conjunctiva must be suitable for implantation with the study device
Key exclusion criteria (21 listed)
- Any condition that would greatly increase the risk of non-rejection graft failure such as Stevens-Johnson syndrome, xerophthalmia or severe exposure keratitis.
- Schirmer's test ≤ 5 mm in 1 minute.
- Clinical evidence of limbal stem cell deficiency.
- History of or active herpes simplex virus keratitis or other acute corneal infection
- Subjects who have had > 3 failed grafts in the ipsilateral eye
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 |
|---|---|---|
| LX201LX201 was a novel sustained-release silicone implant containing 30% cyclosporine A by weight. LX201 was available in two different lengths, 0.50 and 0.75 inch. Each implant is 0.08 inch wide and 0.04 inch in height. The implants are flat on one side (the posterior surface, which is applied to the episclera) and the anterior surface and ends were rounded. | Drug | LX201 0.50 inch implant, LX201 0.75 inch implant |
| PlaceboThe placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A | Other | Placebo 0.75 inch implant |
Primary outcome
prevention of corneal allograft rejection or graft failure
Time frame: 52 weeks
Results and safety
The study was stopped early (reason given: The primary efficacy endpoint was not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2012.
Related trials for Corneal Transplantation
Not yet recruiting
A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
Cornea Disease
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
RecruitingObservational study
Factors Influencing Corneal Donation in Palliative Care Unit
Corneal Transplantation, Corneal Diseases
Not yet recruiting
Utilization of Residual Donor Tissue for Regrafting in Bullous Keratopathy After Corneal Transplantation
Bullous Keratopathy
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.
Eddy Anglade, MD study chair
Chief Medical Officer, Lux Biosciences, Inc.
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LX201 in people with Corneal Transplantation and Corneal Graft Rejection, run by Lux Biosciences, Inc. at 30 sites in 2 countries.
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 21 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 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Germany. 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 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 (reason given: The primary efficacy endpoint was not met). 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.
What does the primary outcome measure?
prevention of corneal allograft rejection or graft failure (time frame: 52 weeks). 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 11 Oct 2012.