- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00447187
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 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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Erlangen, 독일, 91054
- Augenklinik, Universitat Erlangen-Nurnberg
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Essen, 독일, 45122
- Cornea Bank, Universitätsklinikum Essen
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Kiel, 독일, 24105
- Klinik fuer Ophthalmologie Campus Kiel
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Muenchen, 독일, 80336
- Ludwig Maximilians Universität
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München, 독일, 81675
- Augenklinik der Technischen Universität München
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Wuerzburg, 독일, 97080
- Augenklinik Wuerzburg
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Arizona
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Phoenix, Arizona, 미국, 85032
- Cornea Consultants of Arizona
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California
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Loma Linda, California, 미국, 92354
- Loma Linda University Health Care
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Los Angeles, California, 미국, 90033
- USC Doheny Eye Institute
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Florida
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Miami, Florida, 미국, 33136
- Bascom Palmer Eye Institute
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory Eye Center
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Illinois
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Chicago, Illinois, 미국, 60612
- University of Illinois at Chicago
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Indiana
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Indianapolis, Indiana, 미국, 46260
- Price Vision Group
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Maryland
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Baltimore, Maryland, 미국, 21218
- The Eye Center at Union Memorial Hospital
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Baltimore, Maryland, 미국, 21287
- Wilmer Eye Institute, Cornea Service
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Massachusetts
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Boston, Massachusetts, 미국, 02111
- New England Eye Center
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Michigan
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Ann Arbor, Michigan, 미국, 48105
- W.K. Kellogg Eye Center - University of Michigan
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Minnesota
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Bloomington, Minnesota, 미국, 55431
- MN Eye Consultants, P.A.
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Missouri
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Kansas City, Missouri, 미국, 64111
- Tauber Eye Center
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St. Louis, Missouri, 미국, 63141
- Ophthalmology Associates
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New Jersey
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Newark, New Jersey, 미국, 07103
- UMDNJ - New Jersey Medical School Institute of Ophthalmology and Visual Science
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New York
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New York, New York, 미국, 10029
- Mount Sinai School of Medicine
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New York, New York, 미국, 10003
- New York Eye and Ear Infirmary
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Rockville Center, New York, 미국, 11570
- Ophthalmic Consultants of Long Island
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Slingerlands, New York, 미국, 12159
- Cornea Consultants of Albany
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North Carolina
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Durham, North Carolina, 미국, 27705
- Duke University Eye Center
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Ohio
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Cleveland, Ohio, 미국, 44106
- University Hospitals Case Medical Center
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Texas
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Dallas, Texas, 미국, 75231
- Cornea Associates of Texas
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Virginia
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Norfolk, Virginia, 미국, 23502
- Virginia Eye Consultants
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Washington
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Seattle, Washington, 미국, 98104
- Eye Associates NW
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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
Exclusion Criteria:
- 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
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: LX201 0.50인치 임플란트
LX201 임플란트는 30중량%의 사이클로스포린 A를 함유하고 길이는 0.50인치입니다.
|
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. |
실험적: LX201 0.75인치 임플란트
LX201 임플란트는 30중량% 사이클로스포린 A를 함유하고 길이는 0.75인치
|
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. |
위약 비교기: 위약 0.75인치 보형물
0.75인치 길이의 사이클로스포린 A를 함유하지 않은 실리콘 임플란트
|
위약은 0.75인치 길이의 실리콘 임플란트였습니다.
사이클로스포린 A가 포함되어 있지 않습니다.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
graft rejection or graft failure
기간: 52 weeks
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52 weeks
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공동 작업자 및 조사자
수사관
- 연구 의자: Eddy Anglade, MD, Chief Medical Officer, Lux Biosciences, Inc.
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- LX201-01
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
각막 질환에 대한 임상 시험
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University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국
LX201에 대한 임상 시험
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Lux Biosciences, Inc.종료됨