A Phase I Study to Establish the Safety and Efficacy of Retinal Pigment Epithelium Micropulse Laser in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Change in area of atrophy as measured with fundus autofluorescence (FAF)
研究概览
简要总结
Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in broad areas of the retina. The application of subthreshold micropulse laser spots in healthy RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused by the disease (ie, the laser may decrease vascular endothelial growth factor and RPE-derived transforming growth factor beta, upregulation of pigment epithelium-derived factor). This may slow or even stop the enlargement of atrophy secondary to GA, and therefore, avoid further vision loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GA > 0.5 disk areas secondary to AMD in both eyes
- •50 years or older
- •The periphery of the atrophic lesions must demonstrate increased autofluorescence
- •Best corrected visual acuity between 20/20 and 20/400 inclusive
- •Clear ocular media
- •Ability to provide informed consent and attend all study visits
排除标准
- •GA secondary to other causes aside from AMD
- •Evidence of choroidal neovascularization in either eye
- •Any prior treatment for AMD, aside from antioxidants
- •Any other ocular condition that would progress in the study period and confound visual acuity assessment
- •Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve
- •Presence of idiopathic or autoimmune-associated uveitis
- •Any intraocular surgery 3 months of entry
- •Any prior thermal laser in the macula
- •History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery
- •Previous therapeutic radiation in the ocular region in either eye
- •Any treatment with an investigational agent in the previous 60 days before study entry
结局指标
主要结局
Change in area of atrophy as measured with fundus autofluorescence (FAF)
时间窗: Change in area from baseline to week 48
Difference in baseline area of atrophy as measured with FAF at week 48
次要结局
未报告次要终点
研究者
Jordi Mones MD PhD
MD, PhD
Institut de la Macula y la Retina