NL-OMON41786已完成3 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 - GX29176 / CHROMA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Willingness and the ability 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 letter score superior or equal to 49 letters (Snellen equivalent of 20/100 or better) using ETDRS at starting distance of 4m
- •- If BCVA letter score is superior or equal to 79 letters (Snellen equivalent of 20/25 or better), at least one GA easion must be within 250 micrometers of the foveal centre.
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 any 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 (for intraocular conditions), 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 participation in interventional clinical trials for geographic atrophy or dry AMD (except of vitamins and minerals) irrespective of the
- •route of administration (ocular or systemic)
- •- Previous treatment with eculizumab, lampalizumab, fenretidine or any other drugs for geographic atrophy or dry AMD treatment;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
- •- 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 or localized infection. The ongoing prophylactic use of antimicrobial therapy should be discussed
- •with the Medical Monitor.
- •- Predisposition or history of increased risk of infection
- •- Active malignancy within past 12 months except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma
- •and prostate cancer with a Gleason score of < 6 and a stable prostate specific antigen (PSA) for > 12 months.
- •- 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 (except as listed in protocol section 4.1
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