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临床试验/NCT03940690
NCT03940690终止3 期

Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease

Fondation Ophtalmologique Adolphe de Rothschild6 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年10月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
入组人数
18
试验地点
6
主要终点
Proportion of patients with improvement of stage of disease, according to the Shields classification

研究概览

简要总结

Coats disease is a predominantly unilateral progressive retinal vascular disease, characterized by retinal telangiectasias with intra- or subretinal exudate deposits, which can lead to retinal detachment and one-sided blindness. Several treatment modalities are available and the choice of one of them depends on the stage of the disease and the habits of each center (laser photocoagulation, cryotherapy ...). VEGF (Vascular Endothelial Growth Factor) was found to be significantly elevated in the aqueous humor and subretinal fluid of patients with Coats disease. Several studies have shown the potential efficacy of intra-vitreous injections of anti-VEGF. But the results on their effectiveness have been evaluated only on small series of patients. Most published studies have analyzed their efficacy combined with another treatment, mainly laser photocoagulation. The true efficacy of anti-VEGF therapy as initial therapy, and then combined in Coats disease remains unknown. Currently, several centers are initiating first-line anti-VEGF injections, although no rigorous evaluation of this therapeutic strategy has been conducted.

The identification of the best treatment regimen will allow in the future the reduction of laser reprocessing and will ensure a better functional benefit in the affected patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
— 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Coats disease confirmed by fundus examination and fluorescein angiography
  • Stage 2 or 3 at the fundus (Shields classification)
  • Naive to any eye treatment on the eye affected by Coats disease

排除标准

  • Other ocular pathology on the eye affected by Coats' disease
  • Bilateral forms of the disease
  • History of hypersensitivity to bevacizumab
  • History of hypersensitivity to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies
  • Allergic reaction in a previous fluorescein retinal angiogram
  • Pregnancy or breastfeeding
  • Active or suspected periocular infection
  • Contraindication to treatments used for general anesthesia and morphine derivatives
  • Cardiovascular, haemorrhagic and gastrointestinal risks
  • Premature baby who has not reached the correct age of 37 weeks

研究组 & 干预措施

Arm : laser only

Active Comparator

3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9

干预措施: Laser (Device)

Anti-VEGF injections (bevacizumab)

Experimental

5 anti-VEGF injections of bevacizumab at months 0, 1, 2, 4 and 6, combined with laser at months 2, 4 and 6 (laser optional at month 9

干预措施: Anti-VEGF injections of bevacizumab (Drug)

结局指标

主要结局

Proportion of patients with improvement of stage of disease, according to the Shields classification

时间窗: 6 months after randomization

Stages assessed by retinal multimodal imaging (retinophotography, optical coherence tomography when age allows, retinal fluorescein angiography) by two independent expert ophthalmologists

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 (6)

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