2024-517036-21-00招募中2 期
Multicenter randomized controlled trial of the value of intravitreal anti-VEGF injections as initial then adjuvant treatment in Coats' disease
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Proportion of patients with improvement in at least one stage of the disease according to the Shields classification (Am J Ophthalmol, 2001), 6 months after initiation of study treatment
研究概览
简要总结
To compare the efficacy of treatment with intravitreal (IVT) injection of anti-VEGF (bevacizumab, Avastin®) on the stage of Coats' disease, versus reference treatment with laser photocoagulation, 6 months after initiation of study treatment.
研究设计
- 分配方式
- Randomized
- 主要目的
- Prospective, randomized, two parallel arms, controlled, single-blind (patient), multicenter study
- 盲法
- Single (Subject, Analyst)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patient ≤ 16 years
- •Coats disease confirmed by fundus examination and fluorescein angiography
- •Stages 2 or 3 on fundus examination (Shields classification)
- •Naïve to any ocular treatment on the eye affected by Coats' disease
- •Beneficiary of a Social Security scheme
- •Free, informed, written consent of both holders of parental authority
排除标准
- •Other ocular pathology on the eye affected by Coats' disease
- •Pregnancy or breastfeeding
- •Bilateral forms of the disease
- •History of hypersensitivity to bevacizumab
- •History of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or to other human or humanized recombinant antibodies
- •Allergic reaction to previous fluorescein retinal angiography
- •Active or suspected periocular infection
- •Contraindication to treatments used for general anesthesia (Propofol, halogenated gases (Sevoflurane) and morphine derivatives (Sufentanil))
- •Cardiovascular, hemorrhagic and gastrointestinal risks
- •Premature infant under 37 weeks corrected age
结局指标
主要结局
Proportion of patients with improvement in at least one stage of the disease according to the Shields classification (Am J Ophthalmol, 2001), 6 months after initiation of study treatment
Proportion of patients with improvement in at least one stage of the disease according to the Shields classification (Am J Ophthalmol, 2001), 6 months after initiation of study treatment
次要结局
- Comparison, between the 2 groups, of the proportion of patients with an improvement of at least one stage of the Shields classification assessed on multimodal retinal imaging by two independent experts at 2 months, 4 months and 9 months after initiation of study treatment
- Comparison between the 2 groups of each of the items defining the Shields stage at 2, 4, 6 and 9 months after initiation of study treatment: presence of telangiectasia, presence of exudates, presence of retinal detachment; glaucoma, bulbar phthisis
- Comparison between the 2 groups of visual acuity (expressed in logMAR) at 4, 6, and 9 months after initiation of study treatment, in children of verbal age (from 3 years)
- Comparison between the 2 groups of macular thickness variation (in micrometers), the presence of serous detachment, and the maximum thickness of fibrosis observed on optical coherence tomography at 2, 4, 6, and 9 months after initiation of study treatment in children for whom it was performed
- Comparison between the 2 groups in terms of the number of patients requiring additional treatment (i.e., an additional laser session beyond the third session or surgical treatment) 9 months after initiation of study treatment
- Comparison between the 2 groups in terms of the number of events and adverse effects (i.e., progression to stage 5 (phthisis); need for surgical treatment; cataract; vitreoretinal fibrosis; tractional retinal detachment, as well as any serious adverse event detected by the investigator leading to discontinuation of treatment)
- Calculation of the kappa coefficient, measuring the agreement between the two independent expert ophthalmologist evaluators at each evaluation of Coats disease stage at 0, 1, 2, 4, 6, and 9 months after initiation of study treatment
研究者
Clinical research Department
Scientific
Fondation A De Rothschild
研究点 (6)
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