Neovascular Age-related Macular Degeneration
关键词
抽象
日期
| 最后验证: | 03/31/2018 |
| 首次提交: | 10/18/2012 |
| 提交的预估入学人数: | 10/18/2012 |
| 首次发布: | 10/22/2012 |
| 上次提交的更新: | 04/02/2018 |
| 最近更新发布: | 04/04/2018 |
| 实际学习开始日期: | 09/30/2012 |
| 预计主要完成日期: | 12/04/2017 |
| 预计完成日期: | 12/04/2017 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Treatment-active NVAMD Patients with NVAMD who have received treatment with an anti-VEGF agent (Avastin, Lucentis, Macugen, or Eylea) 6 weeks prior enrollment visit | |
| Treatment-naive NVAMD Individuals who have not received any treatment for neovascular AMD in the study eye |
资格标准
| 有资格学习的年龄 | 50 Years 至 50 Years |
| 有资格学习的性别 | All |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Presence of Neovascular AMD confirmed by fluorescein dye leakage on angiogram or presence of at least one of the following on OCT: subretinal fluid, intraretinal fluid, or sub-retinal pigment epithelial fluid. - Treatment naïve group consists of individuals who have not received any treatment for neovascular AMD in the study eye - Active treatment group consists of individuals who have received treatment with an anti-VEGF agent (Avastin, Lucentis, Macugen, or Eylea) 6 weeks prior enrollment visit Exclusion Criteria: - Inability to give informed consent. - Inability to maintain stable fixation for OCT imaging - Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. - A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control). - Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible. - Women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography. - Unable to ambulate and take tram from clinic to where OCT is located - Prior macular laser treatment - Subretinal hemorrhage or fibrosis >50% of choroidal neovascular lesion - Visual acuity 20/200 or worse - An ocular condition is present such that, in the opinion of the investigator, may alter the retinal anatomy (eg: epiretinal membrane) - An ocular condition is present (other than Neovascular AMD) that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, etc.). - Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal). - History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months. |
结果
主要结果指标
1. Number of patients with NVAMD receiving treatment who also have changed retinal/choroidal anatomy and/or blood flow compared to treatment naive NVAMD patients [1 year]
