ACTRN12619001315101终止未知
A clinical study to evaluate the safety and feasibility of the OcuDyne system in the treatment of age-related macular degeneration (AMD)
OcuDyne Australia Pty Ltd0 个研究点目标入组 6 人开始时间: 2019年9月26日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 60 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adults at least 60 years of age at the time of consent
- •2. Diagnosed with non-exudative Age-Related Macular Degeneration with current or previous evidence of at least one large drusen (measuring 125 microns or greater) and nascent geographic atrophy (nGA) or GA in the study eye
- •3. ETDRS BCDVA letter score of between 55 and 20 letters (Snellen equivalent of 20/80 to 20/400) in the study eye, which in the Investigator’s judgment is caused by non-exudative AMD
排除标准
- •1.Any surgical intraocular treatment (including laser) within 3 months in the study eye.
- •2.History of exudative AMD or Anti-Vascular Endothelial Growth Factor (anti-VEGF) injections in the study eye.
- •3.Presence of ocular media affecting visual acuity or the ability to visualize the retina in either eye (e.g. central corneal scarring, lens opacities along visual axis, posterior capsule opacification, etc.).
- •4.History of chronic, recurring inflammatory eye disease in either eye (e.g., scleritis, uveitis, corneal edema, etc.)
- •5.Presence of diabetic retinopathy in either eye.
- •6.Evidence of macular edema secondary to exudation in the study eye.
- •7.History of amaurosis fugax, central or retinal artery or vein occlusion, anterior ischemic optic neuropathy (AION) or non-arteritic anterior ischemic optic neuropathy (NAION) in the study eye.
- •8.Myopia > 6.0 Diopters (D) or Axial Length equal to or greater than 26.0 mm in the study eye.
- •9.Presence of visually significant epiretinal membrane in the study eye.
- •10.Participation in any eye-related drug or device clinical trial involving either eye within 90 days prior to enrolling in this study and/or during study participation.
- •11.Any condition that prohibits the use of intravenous contrast agents (e.g. renal insufficiency, previous anaphylactoid reaction to contrast material, treatment with nephrotoxic agents, etc.).
- •12.Previous stroke, including ischemic, hemorrhagic or transient ischemic attack (TIA).
- •13.Previous myocardial infarction (MI), including ST segment elevation (STEMI), non-ST segment elevation (NSTEMI) or coronary spasm/angina.
- •14.Coronary or other intravascular percutaneous procedure, including balloon angioplasty, stent or filter placement within 6 months.
- •15.Presence of cranial aneurysm, clinically significant stenosis in common carotid artery or internal carotid artery, or tortuous vascular anatomy as seen on pre-procedural CT Angiogram that, in the clinical judgement of the investigator, represents an unreasonable risk to perform the intervention.
- •16.Condition associated with increased bleeding risk including but not limited to: major surgical procedure or trauma within 30 days of screening; clinically significant gastrointestinal bleeding within 1 year of screening; known gastric or duodenal ulcer; history of intracranial or spinal bleeding; chronic hemorrhagic disorder; treatment with oral anticoagulant medications (e.g., Warfarin / non-vitamin K anticoagulants [NOACs] exclusionary; aspirin or clopidogrel allowed), known intracranial neoplasm, arteriovenous malformation, or aneurysm.
- •17.Sustained and uncontrolled hypertension with systolic blood pressure > 180 mmHg.
- •18.Diagnosis of moderate to severe symptomatic chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD)
- •19.Diagnosis of connective tissue disease (e.g., lupus, rheumatoid arthritis, scleroderma, etc.).
- •20.Intolerance of either pre- or post- procedure medication regimen.
- •21.Pregnancy, lactation, or plans to become pregnant during participation in this clinical trial.
- •22.Participation in any other non-eye related drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation.
- •23.Use of facial fillers or paralytic drugs during study participation.
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