2024-516681-10-01已完成2 期
Spontaneous Retinal Arterial Pulsations (SRAPs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVOs) in patients treated or not with intravitreal injections of aflibercept
Fondation A De Rothschild, Fondation A De Rothschild, Fondation A De Rothschild3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in visual acuity (BCVA on ETDRS scale) in letters read and validated between the start of treatment and 1 year.
研究概览
简要总结
To compare the evolution of visual acuity between inclusion and the one-year visit in CRVO patients with PARS versus those without PARS.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Study Design
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient over 18
- •Diagnosis of CRVO (central retinal vein occlusion), with or without macular edema.
- •Naïve to intravitreal injection and intravitreal corticosteroid implant
- •Member or beneficiary of a health insurance scheme
- •Having received informed information about the study and having signed a consent form to participate in the study
- •For women of childbearing age: commitment to effective contraception during aflibercept treatment and for at least 3 months after the last intravitreal injection of aflibercept
- •Onset of symptoms in previous month (maximum 30 days prior to inclusion)
排除标准
- •Patient under legal protection
- •Macular edema of etiology other than CRVO (central retinal vein occlusion)
- •Active or suspected ocular or periocular infection
- •Secondary exclusion criteria: ocular media opacities
- •Secondary exclusion criteria: diabetic retinopathy
- •Secondary exclusion criteria: administration of a drug other than aflibercept during the study
- •Severe intraocular inflammation
- •Hypersensitivity to EYLEA® : to the active substance (aflibercept) or to one of the excipients
- •Pregnant or breast-feeding women
- •Previous stroke or myocardial infarction within the last 3 months
- •Untreated retinal detachment or dehiscence
- •Ocular media opacities
- •Diabetic retinopathy
结局指标
主要结局
Change in visual acuity (BCVA on ETDRS scale) in letters read and validated between the start of treatment and 1 year.
Change in visual acuity (BCVA on ETDRS scale) in letters read and validated between the start of treatment and 1 year.
次要结局
- Macular edema will be determined by the ophthalmologist from the OCT examination
- Measurement of macular thickness in μm is performed using OCT-integrated measurement software
- CRVO complications will be collected at one year from the patient's record
- The number of aflibercept injections during the first year of follow-up will be collected at one year from the patient's record
- The time between the last 2 injections of aflibercept will be collected at one year from the patient's file
研究者
Clinical research Department
Scientific
Fondation A De Rothschild
研究点 (3)
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