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Corneal DiseasesPhase 3NCT00447187

Study to Assess the Efficacy and Safety of LX201 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure in Subjects at Increased Immunological Risk

A Phase 3 study testing LX201 in people with Corneal Diseases and Cornea Transplant, run by Lux Biosciences, Inc. at 30 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This was a pivotal trial to determine whether LX201 reduces the likelihood of a graft rejection episode following corneal transplantation in patients at high immunological risk for rejection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Corneal Diseases, Cornea Transplant
What is being tested?
LX201
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
368 participants
Where
30 sitesin 2 countries
Study dates
Apr 2007to Nov 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 are candidates for a corneal transplant and are at increased immunological risk for graft failure, as evidenced by one or more of the following:
  • ≥ 1 quadrant deep corneal vascularization
  • verifiable history of graft failure due to rejection
  • position of graft is < 1 mm from the limbus

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 study 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™ 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 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
  • Severe anemia (hemoglobin < 6 g/dL), leukopenia (white blood cell count [WBC] < 2500 mm3), thrombocytopenia (platelet count < 80,000 mm3), polycythemia (hematocrit [Hct] > 54% [male] or Hct > 49% [female]) or clinically significant coagulopathy
  • 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

Other trials in United States

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

Other trials in Germany

About this study

Official title: A Multi-center, Placebo-Controlled, Randomized, Parallel Group, Dose-Ranging Study to Assess the Efficacy and Safety of LX201 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure Following Penetrating Keratoplasty With LX201 Implantation in Subjects Who Are at Increased Immunological Risk

This was a pivotal trial to determine whether LX201 reduces the likelihood of a graft rejection episode following corneal transplantation in patients at high immunological risk for rejection.

Read the detailed description

LX201 was a novel sustained-release silicone implant containing 30% cyclosporine A by weight. LX201 was 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 following penetrating keratoplasty with LX201 implantation. Subjects were to be followed in an outpatient setting for safety and efficacy at 4-6 week intervals for 52 weeks following transplantation surgery.

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. For subjects in the USA and India, if the implant was removed at any time prior to the 3 year safety follow-up, the subject was to have a final safety follow up visit at 3 months post removal. In Germany, the implant was to be removed at Week 52 with a 3-month safety follow-up period after removal.

Being tested
LX201, Placebo
Keywords
corneal graft failure, corneal graft rejection, corneal transplant rejection
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 is 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 was 0.08 inch wide and 0.04 inch in height. The implants were 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 groups in NCT00447187
Study groupRoleWhat they receive
LX201 0.50 inch implantExperimentalLX201 implant contained 30% cyclosporine A by weight and 0.50 inch in length
Receives: Drug: LX201
LX201 0.75 inch implantExperimentalLX201 implant contained 30% cyclosporine A by weight and 0.75 inch by length
Receives: Drug: LX201
Placebo 0.75 inch implantPlacebo comparatorSilicone 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.

  1. graft 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.

  1. First posted14 Mar 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionMar 2009
  4. Study completionNov 2010

Why it stopped: The primary efficacy endpoint was not met

Resources

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
368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00447187
Sponsor's protocol ID
LX201-01
Status last verified
Oct 2012
First submitted
12 Mar 2007
Last updated
11 Oct 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Bock F, Matthaei M, Reinhard T, Bohringer D, Christoph J, Ganslandt T, Cursiefen C. High-dose subconjunctival cyclosporine a implants do not affect corneal neovascularization after high-risk keratoplasty. Ophthalmology. 2014 Sep;121(9):1677-82. doi: 10.1016/j.ophtha.2014.03.016. Epub 2014 Apr 26.

    PubMed 24780407

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LX201 in people with Corneal Diseases and Cornea Transplant, 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 4 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?

graft 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?

On the ClinicalTrials.gov record for NCT00447187, 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 11 Oct 2012.

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