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临床试验/NCT04793100
NCT04793100已完成不适用

Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections

Fondation Ophtalmologique Adolphe de Rothschild3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
3
主要终点
Change in visual acuity between inclusion and visit at one year compared between patients with SPARs versus without SPARs

研究概览

简要总结

Central retinal vein occlusion (CRVO) is the second most common retinal vascular disease after diabetic retinopathy. It induces circulatory slowdown and blood stasis, which can appear as retinal hemorrhages. CRVO has been classically separated into two clinical forms: ischemic CVRO (possibly associated with cotton wool spots) and non-ischemic CRVO, the former being considered the most serious due to neovascular complications. More recently, a new classification has been suggested by Pierru et al. distinguishing two types of CRVO: type A characterized by low acute blood flow and type B with a slower onset. Type A is particularly associated with younger age, the presence of acute paracentral middle maculopathy, concomitant cilioretinal artery occlusion, and/or pulsatile arterial filling. Type B is more likely to occur in elderly patients, usually with high blood pressure, and multiple hemorrhages are frequently found on fundus examination.

A retrospective study had shown a slight difference in favor of pulsatile CRVO in terms of the number of intravitreal anti-angiogenic injections required to treat macular edema and visual acuity changes. However, no statistically significant difference was observed.

The objective of this study is to prospectively investigate whether spontaneous retinal artery pulses (SPARs) in patients with type A or B CRVO can be considered as a prognostic factor for the evolution of CRVO.

详细描述

In order to be able to interpret the results on a homogeneous population, given that several molecules have marketing authorization for the management of macular edema following a CRVO, the therapeutic management will be standardized by the use of aflibercept for patients requiring intravitreal injection, aflibercept being the most widely referenced treatment currently used in the participating centers.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of CRVO, with or without macular edema.
  • Onset of symptoms in the previous month (maximum 30 days prior to inclusion)
  • Naive of intravitreal injection and intravitreal corticosteroid implant
  • If woman of childbearing age: commitment to effective contraception during treatment with aflibercept and for at least 3 months after the last intravitreal injection of aflibercept

排除标准

  • Pregnant or breastfeeding woman
  • History of stroke or myocardial infarction in the last 3 months
  • Retinal detachment or untreated retinal dehiscence
  • Opacity of ocular media
  • Amblyopia
  • Diabetic retinopathy
  • Macular edema of a different etiology than CRVO
  • Active or suspected ocular or periocular infection
  • Severe intraocular inflammation
  • Hypersensitivity to EYLEA® : to the active substance (aflibercept) or to one of the excipients

研究组 & 干预措施

Follow-up for 1 year

Experimental

干预措施: Ophthalmologic exam at inclusion and 12 months after CRVO (Other)

Follow-up for 1 year

Experimental

干预措施: Treatment standardization with aflibercept (Drug)

结局指标

主要结局

Change in visual acuity between inclusion and visit at one year compared between patients with SPARs versus without SPARs

时间窗: At inclusion and 12 months after CRVO

Evolution of best corrected visual acuity on ETDRS scale (Early treatment diabetic retinopathy study scale) in letters read and validated Infrared movies will be made at inclusion from the Heidelberg Spectralis device. Two ophthalmologists blinded to each other will view the films. The arterial pulses are visualized at the optic disc site in the form of pulse-dependent beats of the arterial walls. For each movie each ophthalmologist will give his assessment: SPARs+ or SPARs-. In case of discrepancy, a third ophthalmological opinion will be requested.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (3)

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