Subconjunctival Sirolimus in the Treatment of AMD Bilateral Geographic Atrophy

评价结膜下西罗莫司治疗与年龄相关性黄斑变性相关的双侧地图样萎缩的初步研究 这项研究将确定一种名为西罗莫司的药物是否可以安全地用于地图状萎缩症患者，以及它是否可以帮助保护患者的视力。GA是干性年龄相关性黄斑变性（AMD）的晚期形式。AMD影响黄斑，视网膜的中心部分需要敏锐，清晰的视觉。有两种类型的AMD，湿型和干型。在干性AMD中，黄斑中的细胞死亡。GA可能至少部分由炎症引起。西罗莫司有助于预防炎症，因此可能有助于治疗GA。 双眼GA且每只眼视力在20/20和20/400之间的患者可能有资格参加本研究。参与者将接受以下测试和程序： - 在每次3个月临床访视时，在研究眼中注射西罗莫司。这种药物是在病人接受消毒和麻木滴剂后注射到眼睛外层下的。抗生素滴剂在注射后持续2天。 - 首次注射前、首次注射后1个月、每次门诊访视期间（2 - 3年内11 - 15次访视）和末次注射后3个月进行眼部检查。检查包括测试视力、测量眼压和检查眼球运动。为了检查眼睛的内部，用眼药水使瞳孔扩张。在眼睛检查期间，可以拍摄眼睛内部的常规照片和光学相干断层扫描照片，其允许测量视网膜的厚度。 - 自体荧光成像。病人坐在椅子上，头放在摄像机前的下巴托上。相机中的一盏灯被用来扫描眼睛。 - 验血。在第一次访视和最多七次研究访视时抽血，以检查血液化学，如肝脏和肾脏功能。 - 尿妊娠试验适用于能够怀孕的女性。

Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral Geographic Atrophy Associated with Age-Related Macular Degeneration This study will determine if a drug called sirolimus is safe to give to people with geographic atrophy GA and if it can help preserve vision in patients. GA is an advanced form of dry age-related macular degeneration (AMD). AMD affects the macula, the central part of the retina needed for sharp, clear vision. There are two types of AMD, wet and dry. In dry AMD, cells in the macula die.GA may at least partly be caused by inflammation. Sirolimus helps prevent inflammation and therefore may help treat GA. People with GA in both eyes with visual acuity between 20/20 and 20/400 in each eye may be eligible for this study. Participants undergo the following tests and procedures: - Sirolimus injections in the study eye at each 3-month clinic visit. The drug is injected under the outer layer of the eye after the patient receives antiseptic and numbing drops. Antibiotic drops are continued for 2 days after the injection. - Eye examinations before the first injection, 1 month after the first injection, during each clinic visit (11 to 15 visits over 2 to 3 years) and 3 months after the final injection. The examination includes testing visual acuity, measuring eye pressure and checking eye movements. To examine the inside of the eye, the pupil is dilated with eye drops. Regular photographs of the inside of the eye and optical coherence tomography photographs, which allow measurement of the thickness of the retina, may be taken during the eye examination. - Autofluorescence imaging. The patient sits in a chair with his or her head placed in a chin rest in front of a camera. A light in the camera is used to scan the eye. - Blood tests. Blood is drawn at the first visit and at up to seven study visits to check blood chemistries, such as liver and kidney function. - Urine pregnancy test for women who are able to become pregnant.