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Long-term Retinal Implant Study Offers Hope For Treating Blindness
ScienceDaily (Feb. 18, 2008) — USC and Second Sight Medical Products Inc, leading developers of retinal prostheses for treating blindness, announced today that they have completed enrollment of the first phase of a U.S .FDA approved clinical study of the Argus II Retinal Prosthesis System. They also announced that enrollment at key European sites is underway as studies continue in Mexico.
\"We are pleased that Second Sight, along with our fantastic clinical partners, was able to fully enroll the US trial in a timely manner,\" said Robert Greenberg, MD, PhD, President and CEO of Second Sight, and a leader in the field of retinal prostheses for more than 15 years.
\"Although it is too early to comment on the clinical data, each device continues to function as expected, and all participants are using their systems at home daily.\"
The Argus II is the second generation of an electronic retinal implant designed for the treatment of blindness due to Retinitis Pigmentosa (RP), a group of inherited eye diseases that affect the retina. The Argus II implant consists of an array of 60 electrodes that are attached to the retina. These electrodes conduct information acquired from an external camera to the retina to provide a rudimentary form of sight to implanted subjects.
The development of this technology was largely supported by the National Eye Institute (NEI) of the National Institutes of Health (NIH), and the Department of Energy's Office of Science (DOE) Artificial Retina Project, which is helping to advance the implant's design and construction. The unique resources and expertise at DOE national laboratories--particularly in engineering, microfabrication, material science, and microelectronic technologies--are enabling the development of much smaller, higher resolution devices.
Ten subjects were recruited for the Phase I trial at four leading ophthalmic centers throughout the US, including the Doheny Eye Institute at the University of Southern California (USC), Wilmer Eye Institute at Johns Hopkins University (Baltimore), the University of California at San Francisco, and the Retina Foundation of the Southwest (Dallas). Second Sight will be seeking expansion of the U.S. trial to include other trial sites located in New York (Columbia University Medical Center and Lighthouse International), Philadelphia (Scheie Eye Institute and Wills Eye Hospital) and Atlanta (Emory University and Atlanta V.A. Rehab R&D Center). This three-year Investigational Device Exemption (IDE) trial is the only long-term study of a retinal prosthesis currently being conducted anywhere in the world.
Internationally, the Argus II study began in Mexico in the fall of 2006 at Centro de Retina Medica y Quirurgica, SC, Centro Medico Puerta de Hierro, CUCS, Universidad de Guadalajara (Guadalajara, Jal.). More recently, enrollment has just begun at two European sites, including Service d'Ophtalmologie, H魀ital Cantonal, Universitaire de Genève (Geneva, Switzerland) and Le Centre Hospitalier National D'Ophtalmologie Des Quinze-Vingts (Paris, France). A third study site at Moorfields Eye Hospital in London has recently received government approval and is expected to begin enrollment shortly.
\"The pioneering efforts of the individuals that participate in this clinical trial will lead to advances for the many people in the world afflicted with blindness,\" said Mark Humayun, MD, PhD, Professor of Ophthalmology, Biomedical Engineering, and Cellular and Neurobiology at the Doheny Eye Institute, Keck School of Medicine of USC, and Viterbi School of Engineering and the first physician to perform an Argus II implantation procedure in the US.
Dr. Humayun was the vitreo-retinal surgeon for the first generation 16-electrode (Argus- 16), which he implanted in six RP subjects between 2002 and 2004. The study demonstrated the ability of participants to detect when lights are on or off, describe an object's motion, count discrete items, as well as locate and differentiate basic objects in an environment.
\"We are excited about the progress being made in the development of this artificial retina technology,\" says Stephen Rose, PhD, Chief Research Officer, Foundation Fighting Blindness (FF[Black Eye].
\"FFB supported early preclinical studies of this technology, because of its great potential for giving vision to people with the most advanced retinal disease and we are pleased to have helped advance the prosthesis into critical clinical trials.\"
Second Sight and USC have received extensive U.S. federal support in developing this new technology and are grateful for the forward thinking of the National Institutes of Health/National Eye Institute and the Office of Science at the Department of Energy in supporting significant aspects of this work.
Other sources of funding for the work at the Doheny Eye Institute at USC include the National Science Foundation, which supported the development of the Argus II integrated circuit, the W.M.Keck Foundation, Research to Prevent Blindness and the Albaugh Family Trust.
南加利福尼亚大学和第二视力医疗产品公司，指导视网膜假体的开发人员治疗失明。今天宣布他们已经完成了美国食品及药物管理局批准对阿格斯II型视网膜假体系统的临床研究的第一阶段的注册。他们也声称就象在墨西哥的继续研究一样，在某些欧洲关键地点的注册正在着手进行中。
“尽管现在对这些临床数据下评论还太早，但是每一部分装置都象预期一样继续发挥作用，并且所有的参与者在日常生活中都正在使用他们的这个系统。”
阿格斯II型视网膜假体系统是为视网膜色素变性而导致的失明治疗而设计的第二代电子视网膜植入物，视网膜色素变性是一组能影响到视网膜的遗传性眼部疾病。阿格斯II型视网膜假体系统由一系列６０个附在视网膜上的电极组成。这些电极将从外部摄像机获得的信息传递给视网膜以提供对植入物体的一个初级的视觉形式。
这项技术的发展主要是国家健康协会下属的国家眼科协会和科学人工视网膜计划的能源部门大力支持的，他们帮助提出了植入物的设计和构思。在能源部国家实验室这种独一无二的方法和专门技能特殊地用在了工程学，微型品制造，材料科学，和微电子技术等方面，使体积更小，分辨率更高的装置得以研发。
第一阶段试验在遍布美国的四个领头眼科中心添加了十个研究对象。这四个眼科中心包括南加利福尼亚大学（USC）的多希尼眼科学院，约翰斯.霍普金大学（巴尔地摩）的威尔默眼科学院，旧金山的加利福尼亚大学，和西南部的视网膜基金会（达拉斯）第二视力医疗产品公司将扩建美国试验地点包括在纽约（哥伦比亚大学医学中心和，费拉德尔菲亚，和亚特兰大等地的其它试验地点。这三年的豁免审查设计试验是目前世界唯一一次被指示的视网膜假体的长期研究。
和国际接轨，2006年的秋天阿格斯II型视网膜假体系统在视网膜医学 ，南卡罗来纳州，，，瓜达拉哈拉，最近，又开始了两个欧洲地点的注册，包括 。在伦敦穆尔菲尔德眼科医院的第三次研究地点最近被政府批准了并且预计短期内就能注册。
“参与到这次临床试验的研究人员的开拓努力将使全世界许多被失明折磨的人提前摆脱困苦。” 马克.胡马云说。马克.胡马去是医学博士，公共卫生博士，眼科学教授，生物医学工程师，同时也是多希尼眼科学院的细胞学与神经生物学家，南加利福尼亚大学医学部凯特学校的校长，维泰尔比工程学校校长，更是在美国第一个参与执行阿格斯II型视网膜假体系统的医生。
胡马云博士是十六个电极的第一代的玻璃体视网膜外科手术医生，在2002年到2004年之间第一代阿格斯系统被植入到6位参与实验的患者。研究表明参与者能够借助这种装置捕捉光线，描述物体的运动，计数分离项目，也可以在环境中找出和区分基本的物体。
“我们对这次人工视网膜技术的开发所取得的成就感到十分兴奋”。斯蒂芬.罗斯说。她是公共卫生博士，首要研究官员和盲人抗战基金会（FFB）的成员。
盲人抗战基金会支持着这项技术早期的临床前期研究，因为面对最高深的视网膜疾病这项技术给人们带来了极大恢复视力的可能性，并且我们很乐意帮助将视网膜假体提前进入关键的临床试验。
第二视力产品公司和南加利福尼亚大学在研发这项技术时受到了美国联邦政府的巨大支持，并且也对国际健康研究院，国际眼科研究院和能源部门科学办公厅在这项工作上面有支持性意义的各个方面提出观点而表示感谢。
这项在南加利福尼亚大学的多希尼眼科研究院所做的工作的基金来源包括支撑着阿格斯II型视网膜假体系统集成电路的研发过程的国际科学基金会，，防盲研究会和 家庭信任。 |
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发表于 2008-2-27 17:17:24