Subconjunctival Sirolimus in the Treatment of AMD Bilateral Geographic Atrophy

西罗莫司结膜下注射治疗老年性黄斑变性所致双眼地理性萎缩的初步研究 这项研究将确定一种名为西罗莫斯的药物给患有遗传性地理萎缩的人是否安全，以及它是否有助于保护患者的视力。GA是干性老年性黄斑变性(AMD)的高级表现形式。AMD会影响黄斑，这是视网膜的中心部分，需要清晰的视力。AMD有两种类型，湿性和干性。在干性AMD中，黄斑中的细胞死亡。GA至少部分是由炎症引起的。西罗莫司有助于预防炎症，因此可能有助于治疗GA。 双眼视力在20/20到20/400之间的GA患者可能符合这项研究的条件。参与者需要接受以下测试和程序： -在每次3个月的临床就诊时在研究眼注射西罗莫司。在患者接受杀菌和麻木滴剂后，该药物被注射到眼睛的外层下。抗生素滴剂在注射后持续2天。 -在第一次注射前、第一次注射后1个月、每次诊所就诊期间(2至3年内11至15次就诊)和最后一次注射后3个月进行眼睛检查。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，用眼药水放大瞳孔。可以在眼睛检查期间拍摄眼睛内部的常规照片和允许测量视网膜厚度的光学相干断层扫描照片。 -自体荧光成像。病人坐在椅子上，头放在下巴上，面对着摄像机。相机中的一盏灯用来扫描眼睛。 -验血。在第一次就诊和最多七次研究访问时抽取血液，以检查血液化学，如肝和肾功能。 -对有能力怀孕的妇女进行尿液验孕。

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.