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

NCT00447642 | Terminated Phase 3 DMC

• 1 other identifier: LX201-02
• Study Type: interventional
• Target: 122
• Locations: 2 countries
• Sites: 30

Brief 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.

Conditions

Corneal Transplantation; Corneal Graft Rejection

Keywords

immunology; cornea; allograft; corneal allograft rejection; graft failure

Outcome Measures

Primary Outcomes (1)

• prevention of corneal allograft rejection or graft failure

  52 weeks

Study Arms (3)

LX201 0.50 inch implant

EXPERIMENTAL

LX201 implant contained 30% cyclosporine A by weight and 0.50 inch in length

Drug: LX201

LX201 0.75 inch implant

EXPERIMENTAL

LX201 implant contained 30% cyclosporine A by weight and 0.75 inch by length

Drug: LX201

Placebo 0.75 inch implant

PLACEBO COMPARATOR

Silicone implant not containing cyclosporine A, 0.75 inch in length

Other: Placebo

Interventions

LX201 DRUG

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.

LX201 0.50 inch implant; LX201 0.75 inch implant

Placebo OTHER

The placebo was a silicone implant 0.75 inch in length. It contained no cyclosporine A

Placebo 0.75 inch implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lux Biosciences, Inc.: lead

Study Sites (30)

Cornea Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Loma Linda University Health Care

Loma Linda, California, 92354, United States

Location

USC Doheny Eye Institute

Los Angeles, California, 90033, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Emory Eye Center

Atlanta, Georgia, 30322, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

The Eye Center at Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Wilmer Eye Institute, Cornea Service

Baltimore, Maryland, 21287, United States

Location

New England Eye Center

Boston, Massachusetts, 02111, United States

Location

W.K. Kellogg Eye Center - University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

MN Eye Consultants, P.A.

Bloomington, Minnesota, 55431, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63141, United States

Location

UMDNJ - New Jersey Medical School Institute of Ophthalmology and Visual Science

Newark, New Jersey, 07103, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Ophthalmic Consultants of Long Island

Rockville Centre, New York, 11570, United States

Location

Cornea Consultants of Albany

Slingerlands, New York, 12159, United States

Location

Duke University Eye Center

Durham, North Carolina, 27705, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cornea Associates of Texas

Dallas, Texas, 75231, United States

Location

Virginia Eye Consultants

Norfolk, Virginia, 23502, United States

Location

Eye Associates NW

Seattle, Washington, 98104, United States

Location

Augenklinik, Universitat Erlangen-Nurnberg

Erlangen, 91054, Germany

Location

Cornea Bank, Universitätsklinikum Essen

Essen, 45122, Germany

Location

Klinik fuer Ophthalmologie Campus Kiel

Kiel, 24105, Germany

Location

Ludwig Maximilians Universität

München, 80336, Germany

Location

Augenklinik der Technischen Universität München

München, 81675, Germany

Location

Augenklinik Wuerzburg

Würzburg, 97080, Germany

Location

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Eddy Anglade, MD

  Chief Medical Officer, Lux Biosciences, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 15, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: January 1, 2010
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

DE (6); US (24)