Macular Drusen Evolution in Patients With Intermediate Age-related Macular Degeneration (AMD) Taking Oral Food Supplementation: an Open-label,Single-arm Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- evolution of drusen in the macula
研究概览
简要总结
LT7082-001 is an open-label, single-arm pilot study. Patients with intermediate age-related macular degeneration (AMD) wil take T7082 during 12 months , an association of 4 food supplementations .
The study objectives are to describe morphological changes and evolution of drusen in macula after a 12-month of food supplementation and to assess the safety of T7082
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Informed consent signed and dated
- •Age ≥ 50 years old
- •At least one Eligible Eye, defined by following conditions :
- •Far Best Corrected Visual Acuity (BCVA) ≥ 75 ETDRS letters (or ≥ 20/32 Snellen equivalent)
- •At least one drusen with a minimal diameter of 125 µM assessed by SD-OCT / intermediate age-related macular degeneration
- •Macula sparing
- •Clear ocular media
- •Adequate pupillary dilation
排除标准
- •Presence of other macular disease such as epiretinal membrane or macular telangiectasia.
- •Presence of any geographic atrophy including macular region
- •Any history of retina neovascularization
- •Macula or retinal diseases other than age-related macular degeneration
- •A concurrent ocular pathology that may contribute to vision loss (eg, choroidal neovascularization, glaucoma, visually significant cataract, optic neuropathy, history of retinal surgery) or interfere with acquisition of high-quality images
- •Ocular or periocular infections
- •Presence of congenital retinal pathologies that may impact data collection
- •Exudative AMD
研究组 & 干预措施
T7082
After inclusion, the patients will consume an association of 4 food supplements including Nutrof Total.
干预措施: T7082 (Dietary Supplement)
结局指标
主要结局
evolution of drusen in the macula
时间窗: 2 months, 5 months 8 months and 12 months
Change from baseline in drusen region in 4 categories (disappearance, decrease, stable, increase) at 2, 5 and 6 months by Optical Coherence Tomography (OCT-SD)
morphological changes in the macula
时间窗: 2 months, 5 months 8 months and 12 months
Presence and/or evolution of atrophic area (Yes/No) at 2, 5, 6 and 12 months assessed by autofluorescence
Treatment-Emergent Adverse events (TEAE), Serious treatment-emergent adverse events (STEAE), Treatment-Emergent Adverse Reaction (TEAR)
时间窗: 2 months, 5 months 8 months and 12 months
Frequency of TEAE,STEAE,TEAR
次要结局
未报告次要终点