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临床试验/NCT05031143
NCT05031143已完成2 期

Suprachoroidal Triamcinolone Acetonide Injection A Novel Therapy for Serous Retinal Detachment in Vogt-Koyanagi Harada's Disease

Benha University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
6
试验地点
1
主要终点
Best Corrected Visual Acuity (LogMAR units)

研究概览

简要总结

Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection

详细描述

Suprachoroidal injection, a novel technique for delivering ocular therapies, may facilitate targeted therapeutic delivery to the choroidal and retinal structures than intravitreal injection. Yielding high levels of corticosteroid in the retinal and choroidal layers which was detectable for more than 3 months with limited exposure in the anterior segment. Triamcinolone acetonide is a synthetic corticosteroid formulated as an injectable suspension and has been evaluated in a number of trials to be 7.5 fold more potent anti-inflammatory than cortisone. Triamcinolone acetonide enhance tight junctions between endothelial cells thus reducing vessel leakage. It also has an angiostatic action by inhibition of vascular endothelial growth factor and has a useful effect on many inflammatory retinal diseases. The recommended dose of Triamcinolone acetonide injection is 4 mg/0.1 mL which was administrated in this study. The aim of this study was to assess the efficacy of suprachoroidal Triamcinolone acetonide injection (SCTA) as adjunctive therapy in the management of Vogt-Koyanagi Harada's (VKH) multiple serous retinal detachment (RD) and evaluate best corrected visual acuity (BCVA), intraocular pressure(IOP) and central foveal thickness (CFT) by Optical Coherence Tomography (OCT) in patients diagnosed as VKH at ophthalmology clinic, Benha University, EGYPT and Ebsar eye center, Benha, EGYPT.

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
None

入排标准

年龄范围
47 Years 至 52 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed as VKH serous retinal detachment in the acute phase whom BCVA is not improving after 2 weeks from starting systemic steroids.

排除标准

  • recent intraocular surgery.
  • patients refuse to participate in the study.
  • media opacity and other causes of serous retinal detachment than VKH.

研究组 & 干预措施

SCTA injection (n=6 eyes)

Active Comparator

Suprachoroidal Trimacinolone Acetonide injection 4mg/0.1ml, single dose, follow up for 6 months.

干预措施: Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease (Drug)

结局指标

主要结局

Best Corrected Visual Acuity (LogMAR units)

时间窗: 6 months after injection

Changes in vision from baseline upto 6 months follow up

次要结局

  • Central Foveal Thickness measured by Optical Coherence Tomography(Upto 6 months after SCTA injection)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Abdelshafy

Lecturer of Ophthalmology

Benha University

研究点 (1)

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