KCT0004887招募中未知
Phase 1 study to determine the maximum tolerated dose and to assess the safety, pharmacokinetics, and efficacy of AVI-3207 Inj. in patients with neovascular age-related macular degeneration
Avixgen0 个研究点目标入组 9 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 50(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Age of 50 or older
- •2) Patients who agree to participate in this trial and voluntarily sign a written informed consent
- •3) Active* subfoveal choroidal neovascularization (CNV) caused by neovascular (wet) AMD; the patient must be expected to benefit from the study based on the judgment of the investigator.
- •* Active is defined as the presence of intraretinal or subretinal fluid confirmed by optical coherence tomography (OCT).
- •4) Best corrected visual acuity (BCVA) letter score =25-73 as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) VA chart (Snellen VA 20/320-20/40)
- •5) Maximum size of the neovascular lesion =12 MPS (macular photocoagulation study) disc area
排除标准
- •1) Patients receiving ocular or systemic treatment on the study eye, including photodynamic therapy (PDT) or laser photocoagulation or surgical operation, within 3 months prior to screening for the treatment of neovascular macular degeneration (except functional foods and vitamins)
- •2) Patients who have previously received anti-vascular endothelial growth factor (VEGF) drugs for the treatment of neovascular macular degeneration in the study eye
- •* However, registration may be restricted at the investigator's discretion if the non-study eye is applicable to the following:
- •? Patients who have received anti-vascular endothelial growth factor (VEGF) drugs in the non-study eye within 3 months
- •before screening
- •? Patients who have received anti-vascular endothelial growth factor (VEGF) drugs in the non-study eye but had no drug
- •response at the time of administration
- •? Patients who have had problems with their daily life due to non-study eye after administration of anti-vascular endothelial
- •growth factor (VEGF) drugs
- •3) Patients who have received steroids within 1 month prior to screening
- •4) Macular scars or retinal pigment epithelial damage in the study eye
- •5) CNV in the study eye caused by other factors except AMD
- •6) Diabetic retinopathy
- •7) Diagnosis of retinal detachment or retinal break in the study eye
- •8) Uncontrolled glaucoma in the study eye (intraocular pressure = 25 mmHg despite antiglaucoma treatment)
- •9) Intraocular or periocular surgery on the study eye within 3 months prior to the screening visit
- •10) Cloudiness of crystalline lens and media that might affect the results of funduscopy, fluorescein angiography (FAG), and OCT
- •11) Hypersensitivity reactions to any of the components of the study drug
- •12) Confirmed or suspected ocular or periocular infection
- •13) Intraocular inflammation
- •14) Systemic infection
- •15) Uncontrolled hypertension
- •16) Any of the following conditions of renal impairment as defined by
- •?Serum creatinine above the normal level; or
- •?urine protein: urine creatinine ratio = 1
- •17) Diagnosis of unstable coronary artery disease, angina pectoris, congestive heart failure, or arrhythmia requiring active medical management within 1 month prior to screening
- •18) Diagnosis of myocardial infarction or acute heart failure within 6 months prior to screening
- •19) Patients who have received anticoagulants or antiplatelet drugs within 1 month prior to screening
- •20) History of malignant tumors within 5 years prior to screening (Subjects with malignant tumors that did not recur for =5 years are eligible. Subjects with basal cell carcinoma or cutaneous squamous cell carcinoma that did not recur after resections are also eligible.)
- •21) Diagnosis of peripheral arterial disease
- •22) Autoimmune disease
- •23) Non-healing wound, ulcer, or fracture
- •24) History of allergic reactions to contrast medium
- •25) Pregnant or lactating woman
- •26) A man or woman having planning pregnancy or childbearing potential who does not agree to using one of contraceptives listed below
- •? Surgical sterilization (e.g., bilateral tubal ligation, vasectomy)
- •? Hormonal contraceptives (implant, patch, oral)
- •? Double barrier method [concomitant use of two of the followings: Intrauterine device (IUD), male or female condom with spermicide, diaphragm, sponge, cervical cap]
- •Periodic abstinence (e.g., calendar method, ovulation method, basal body temperature method, post ovulation method) and external ejaculation are not acceptable as appropriate cont
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