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
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
-
Erlangen、德国、91054
- Augenklinik, Universitat Erlangen-Nurnberg
-
Essen、德国、45122
- Cornea Bank, Universitätsklinikum Essen
-
Kiel、德国、24105
- Klinik fuer Ophthalmologie Campus Kiel
-
Muenchen、德国、80336
- Ludwig Maximilians Universität
-
München、德国、81675
- Augenklinik der Technischen Universität München
-
Wuerzburg、德国、97080
- Augenklinik Wuerzburg
-
-
-
-
Arizona
-
Phoenix、Arizona、美国、85032
- Cornea Consultants of Arizona
-
-
California
-
Loma Linda、California、美国、92354
- Loma Linda University Health Care
-
Los Angeles、California、美国、90033
- USC Doheny Eye Institute
-
-
Florida
-
Miami、Florida、美国、33136
- Bascom Palmer Eye Institute
-
-
Georgia
-
Atlanta、Georgia、美国、30322
- Emory Eye Center
-
-
Illinois
-
Chicago、Illinois、美国、60612
- University of Illinois at Chicago
-
-
Indiana
-
Indianapolis、Indiana、美国、46260
- Price Vision Group
-
-
Maryland
-
Baltimore、Maryland、美国、21218
- The Eye Center at Union Memorial Hospital
-
Baltimore、Maryland、美国、21287
- Wilmer Eye Institute, Cornea Service
-
-
Massachusetts
-
Boston、Massachusetts、美国、02111
- New England Eye Center
-
-
Michigan
-
Ann Arbor、Michigan、美国、48105
- W.K. Kellogg Eye Center - University of Michigan
-
-
Minnesota
-
Bloomington、Minnesota、美国、55431
- MN Eye Consultants, P.A.
-
-
Missouri
-
Kansas City、Missouri、美国、64111
- Tauber Eye Center
-
St. Louis、Missouri、美国、63141
- Ophthalmology Associates
-
-
New Jersey
-
Newark、New Jersey、美国、07103
- UMDNJ - New Jersey Medical School Institute of Ophthalmology and Visual Science
-
-
New York
-
New York、New York、美国、10029
- Mount Sinai School of Medicine
-
New York、New York、美国、10003
- New York Eye and Ear Infirmary
-
Rockville Center、New York、美国、11570
- Ophthalmic Consultants of Long Island
-
Slingerlands、New York、美国、12159
- Cornea Consultants of Albany
-
-
North Carolina
-
Durham、North Carolina、美国、27705
- Duke University Eye Center
-
-
Ohio
-
Cleveland、Ohio、美国、44106
- University Hospitals Case Medical Center
-
-
Texas
-
Dallas、Texas、美国、75231
- Cornea Associates of Texas
-
-
Virginia
-
Norfolk、Virginia、美国、23502
- Virginia Eye Consultants
-
-
Washington
-
Seattle、Washington、美国、98104
- Eye Associates NW
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:LX201 0.50英寸种植体
LX201 植入物含有按重量计 30% 的环孢菌素 A,长度为 0.50 英寸
|
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. |
实验性的:LX201 0.75英寸种植体
LX201 植入物含有 30% 的环孢菌素 A(按重量计)和 0.75 英寸(按长度计)
|
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. |
安慰剂比较:安慰剂 0.75 英寸植入物
不含环孢菌素 A 的硅胶植入物,长 0.75 英寸
|
安慰剂是 0.75 英寸长的硅胶植入物。
它不含环孢素A
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
graft rejection or graft failure
大体时间:52 weeks
|
52 weeks
|
合作者和调查者
调查人员
- 学习椅:Eddy Anglade, MD、Chief Medical Officer, Lux Biosciences, Inc.
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- LX201-01
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
LX201的临床试验
-
Lux Biosciences, Inc.终止