Evaluation of Oral Minocycline in Treating Geographic Atrophy Associated with Age-Related Macular Degeneration

口服米诺环素治疗年龄相关性黄斑变性相关地理萎缩的评价

• 批准号: 10930532
• 负责人: Tiarnan Keenan
• 金额: $ 20.4万
• 依托单位: NATIONAL EYE INSTITUTE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10930532
• 关键词: Adverse event; Affect; Age related macular degeneration; Aging; Area; Atrophic; Blindness; Cells; Choroidal Neovascularization; Cicatrix; Clinical; Development; Dose; Dryness; Etiology; Evaluation; Eye; Fundus; Fundus photography; Geographic Locations; Image; Immune; Impairment; Inflammation; Inflammatory; Macular degeneration; Measures; Microglia; Minocycline; Oral; Participant; Patient Recruitments; Patients; Perimetry; Persons; Phase; Photoreceptors; Process; Reading; Retina; Retinal Degeneration; Running; Safety; Severities; Structure of retinal pigment epithelium; Study Subject; United States; Visit; Visual Acuity; arm; geographic atrophy; human old age (65+); luminance; macula; neovascular; ocular surface; phase 2 study; prevent; primary outcome; prospective; rate of change; recruit; safety outcomes; secondary outcome; Adverse event; Affect; Age related macular degeneration; Aging; Area; Atrophic; Blindness; Cells; Choroidal Neovascularization; Cicatrix; Clinical; Development; Dose; Dryness; Etiology; Evaluation; Eye; Fundus; Fundus photography; Geographic Locations; Image; Immune; Impairment; Inflammation; Inflammatory; Macular degeneration; Measures; Microglia; Minocycline; Oral; Participant; Patient Recruitments; Patients; Perimetry; Persons; Phase; Photoreceptors; Process; Reading; Retina; Retinal Degeneration; Running; Safety; Severities; Structure of retinal pigment epithelium; Study Subject; United States; Visit; Visual Acuity; arm; geographic atrophy; human old age (65+); luminance; macula; neovascular; ocular surface; phase 2 study; prevent; primary outcome; prospective; rate of change; recruit; safety outcomes; secondary outcome

This is a multi-center, prospective, single-arm, Phase II study to evaluate minocycline as a potential treatment to decrease the rate of worsening of GA associated with AMD. Participants will undergo a nine month run-in phase prior to receiving investigational product (IP). During this run-in phase, participants will have a total of four pre-treatment visits. Following the run-in phase, beginning at Month 9, participants will receive an oral dose of 100 mg of minocycline twice daily for 36 months. There will be a common termination date, which will take place when the last recruited participant has received 36 months of treatment. Participants who were recruited in the earlier part of the study will continue treatment and be followed every six months until the common termination date. The primary outcome is the rate of change in area of GA based on grading by an external Reading Center of fundus autofluorescence (FAF) images in the assigned study eye. The primary outcome will compare the rates of GA area expansion as determined on FAF images before and following the initiation of IP until 24 months of treatment.. Secondary outcomes will include compare differences in rates of change in best-corrected visual acuity (BCVA), low-luminance VA, area of GA based on fundus photography, macular sensitivity as measured using microperimetry between the run-in and treatment phases. Safety outcomes will include the number and severity of adverse events (AEs). Ocular safety outcomes will be indicated by changes in VA, ocular surface changes, intraocular inflammation and any other ocular changes not consistent with the natural progression of GA.

这是一项多中心的，前瞻性的单臂II期研究，用于评估米诺环素，作为一种潜在的治疗方法，可降低与AMD相关的GA的恶化率。参与者将在接收研究产品（IP）之前进行九个月的磨合阶段。在此磨合阶段，参与者将共有四次预处理访问。在第9个月开始的磨合阶段之后，参与者将每天两次接受100毫克米诺环素的口服剂量，持续36个月。将有一个共同的终止日期，这将发生在最后一位招募的参与者接受36个月的治疗时。在研究的早期招募的参与者将继续治疗，并每六个月遵循每六个月的终止日期。 主要结果是基于在指定的研究眼中的外部阅读中心（FAF）图像的外部阅读中心的分级，GA面积的变化率。主要结果将比较IP启动之前和之后在FAF图像上确定的GA面积扩展率。安全结果将包括不良事件（AES）的数量和严重性。眼部安全结果将通过VA的变化，眼表面变化，眼内炎症和任何其他眼部变化表示与GA的自然进展不一致。