NCT02800356已完成不适用
Subthreshold Laser Treatment for Reticular Pseudodrusen and Incipient Geographic Atrophy Secondary to Age - Related Macular Degeneration: a Pilot Study
Ospedale San Raffaele2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Retinal Sensitivity
研究概览
简要总结
To evaluate the effectiveness of subthreshold laser treatment on retinal sensitivity in patients with reticular pseudodrusen and incipient Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). Secondary objective is to investigate changes in best-corrected visual acuity, atrophy progression and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 and/or Reticular pseudodrusen
- •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
- •Women of child-bearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization at Baseline, unless they are using highly effective methods of contraception during dosing of study treatment
- •Participation in an investigational drug, biologic, or device study within 6 Months prior to Baseline [Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary
结局指标
主要结局
Retinal Sensitivity
时间窗: Baseline, 4 weeks and 12 weeks
Change in retinal sensitivity on customized microperimetry (treated area).
次要结局
- Visual Acuity(Baseline, 4 weeks and 12 weeks)
- The Thickness of the Outer Nuclear Layer in the Treated Area(Baseline, 4 weeks and 12 weeks)
- Number of Partecipants With Adverse and Serious Adverse Events(4 weeks and 12 weeks)
- Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas(4 weeks and 12 weeks)
- Intraocular Pressure(4 weeks and 12 weeks)
研究者
Querques Giuseppe
Head-Medical retina & Imaging unit
Ospedale San Raffaele
研究点 (2)
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