EUCTR2014-000106-35-IT进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LAMPALIZUMAB ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION - Spectri
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 936
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Willingness to provide signed informed consent; additionally, at U.S. sites, patients must provide Health Insurance Portability and Accountability Act (HIPAA) authorization, and in other countries, as applicable according to national laws
- •- Participants aged >/= 50 years
- •Ocular Inclusion Criteria: Study Eye
- •- Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV)
- •- BCVA of 20/100 or better (Snellen equivalent) using ETDRS charts at starting distance of 4 m
- •If BCVA is superior or equal to 20/25, at least one GA lesion must be within 250 micrometers of the foveal centre.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 187
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 749
排除标准
- •GA Characteristics Exclusion Criteria
- •- GA in either eye due to causes other than AMD (monogenetic macular dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies [e.g., chloroquine/hydroxychloroquine maculopathy])
- •Ocular Exclusion Criteria: Study Eye
- •- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
- •- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
- •- Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy
- •- History of prophylactic subthreshold laser treatment for AMD
- •- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation). A single intraoperative administration of a corticosteroid during cataract surgery for cystoid macular edema prophylaxis at least 3 months prior to screening is permitted.
- •Ocular Exclusion Criteria: Non-study eye
- •- Non-functioning non-study eye defined as either:
- •BCVA of hand motion or worse OR no physical presence of non-study eye (i.e., monocular)
- •Ocular Exclusion Criteria: Both Eyes
- •- Previous treatment with eculizumab or participation in eculizumab studies
- •- Previous treatment of either eye with lampalizumab
- •- Previous treatment with fenretinide or participation in fenretinide studies
- •Concurrent Systemic Conditions Exclusion Criteria
- •- Uncontrolled blood pressure (defined as systolic >180 mm Hg and/or diastolic >110 mm Hg while patient is sitting) If a patient’s initial measurement exceeds these values, a second reading may be taken 30 or more minutes later. If the patient’s blood pressure must be controlled by anti hypertensive medication, the patient can become eligible if medication is taken continuously for at least 30 days prior to Day 1.
- •- History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of lampalizumab or that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
- •- Treatment for active systemic infection
- •- Predisposition or history of increased risk of infection
- •- Active malignancy
- •- History of allergy to fluorescein that is not amenable to treatment
- •- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lampalizumab injection
- •- Inability to comply with study or follow-up procedures
- •- Inability to obtain CFP, FAF, and FA of sufficient quality to be analyzed and graded by the central reading center
- •- Previous participation in any studies of investigational drugs within 3 months preceding Day 1 (excluding vitamins and minerals)
研究者
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