NCT03242083已完成不适用
Evaluation de la Quality of Life in Secondary Atrophic Age-related Macular Degeneration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- responses to a quality of life questionnaire
研究概览
简要总结
Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because of progressive deterioration of the macula, patients with AMD complain about progressive visual problems that can impair their quality of life in the physical, mental and social domains. The principal objective principal of this study is to describe the evolution of quality of life between the diagnosis of secondary atrophic AMD and at 18 months after confirmation of diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •For the 2 populations studied
- •Persons who have given consent to take part
- •Persons aged 50 years or older
- •Willing and able to attend all of the scheduled visits and evaluations
- •Macular atrophy or drusen measuring at least 125μm or multiple drusens measuring at least 63μm
- •Atrophic AMD diagnosed on OCT and by autofluorescence and OCT angiography by 2 independent experienced assessors
- •Diagnosed for less than 3 years
- •MAVC score ≥ 19 letters (Equivalent Snellen ≥ 20/400), by using a scale at an initial distance of 4m
- •For patients with secondary atrophic AMD
- •Secondary atrophic AMD, defined by persistent atrophic AMD at 1 year after the last injection of an anti-angiogenic agent, and at least 2 years after the first injection.
排除标准
- •General criteria
- •Persons without national health insurance cover
- •Physical or mental disability ruling out participation
- •Inability to sign the written consent form, adults under guardianship
- •Any participation in a study involving an experimental drug during the previous 3 months (dietary supplements are authorised).
- •Adults under guardianship
- •General medical history
- •Uncontrolled AHT
- •Ophthalmological history
- •Severe non-proliferative or proliferative diabetic retinopathy
- •Uncontrolled glaucoma (defined as an intra-ocular pressure greater than 30mmHg despite treatment with an anti-glaucoma agent) or a history of filtration surgery
- •Corneal disease that could impair vision
- •Monogenic macular dystrophy or toxic maculopathy
- •History of uveitis
- •Amblyopia of the eye concerned
- •Intraocular surgery in the 3 months preceding inclusion
- •History of cornea transplantation in the studied eye
- •Treatment affecting vision: chloroquine and hydroxychloroquine, phenothiazine, tamoxifen, interferon (93), external radiotherapy of the face and neck
- •Ophthalmological examination
- •Significant cataract (LOCS III grade of 5 or above, annexe 5.) (94)
- •Active infection in either eye
- •Central anterior serous or active retinopathy in either eye
- •Choroid neo-vascularisation
- •Active serous retinal detachment
- •Refractive error less than -15D or more than +10D
结局指标
主要结局
responses to a quality of life questionnaire
时间窗: Change compared with baseline score at month 6, month 12 and month 18
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Implantation of SML in Patients With Dry Age-related Macular Degeneration and Myopic MaculopathyLens, IntraocularMyopic MaculopathyAge-Related Macular DegenerationNCT03882606Consorci Sanitari de Terrassa3
已完成
不适用
Assessing the Quality of Life and Social Support in Age-Related Macular Degeneration PatientsAge-Related Macular DegenerationNCT05427994Asfendiyarov Kazakh National Medical University458
招募中
不适用
Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD.Age-related Macular DegenerationNCT06271330Nantes University Hospital100
招募中
1 期
A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular DegenerationAge-Related Macular DegenerationNCT03178149Astellas Institute for Regenerative Medicine42
终止
2 期
A Study of MSI-1256F (Squalamine Lactate) To Treat "Wet" Age-Related Macular DegenerationMacular DegenerationNCT00333476Genaera Corporation140