EUCTR2016-002523-28-GB进行中(未招募)1 期
A Pilot Study Evaluating the Effect of Intravitreal Fluocinolone Acetonide (0.19mg) in Patients with Retinitis Pigmentosa - Iluvien for IRD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Adult patients with retinitis pigmentosa and signs of intraocular inflammation (vitreous cells, cataract, epiretinal membrane, intraretinal oedema, clinically significant migration of pigment cells into the retina??).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Patients in whom Fluocinolone Acetonide is contraindicated (prior infectious eye disease, glaucoma or ?steroid induced ocular hypertension). ?
- •?2.? Patients with a clinically apparent asymmetric expression of their retinopathy (as determined by an experienced retina physician).?
- •?3.? High ametropia (greater than ±6D) to avoid complications of cataract surgery should it be ?necessary.?
- •?4.? Patients with planned intraocular surgery within the study period.?
- •5. Patients with dense cataract precluding adequate fundus imaging.
- •6. Female patients who are pregnant or breastfeeding. Female patients of child-bearing age should ensure an adequate contraceptive measure is used.
- •7. Patients known to require other forms of systemic immunosuppression within the study period.
研究者
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