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临床试验/NCT04853355
NCT04853355撤回4 期

Non-Responsive Diabetic Macular Edema in Patients With Pachychoroid and Choroidal Hyperpermeability.

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家开始时间: 2022年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Proportion of eyes with complete reabsorption of intraretinal fluid

研究概览

简要总结

Diabetic patients with macular edema and choroidal hyperpermeability (as manifested as a thick choroid on OCT (optical coherence tomography) and ICG hyperfluorescence on ICG) unresponsive to anti-VEGF (vascular endothelial growth factor) and steroid injections will be treated with spironolactone in addition to the continued treatment of anti-VEGF injections, specifically aflibercept (Eylea).

详细描述

This is a non-randomized, prospective study of 10 patients referred during the years 2018 to 2020 with the diagnosis of Diabetic Macular Edema. Each patient was noted to have pachychoroid, choroidal hyperpermeability, and most important resistant to multiple anti-VEGF and steroid intravitreal injections, and have moderate vision loss. In addition, despite the fact that we use anti-VEGF medications, we do not know the levels of VEGF in the eye, nor do we have an explanation for the inability to respond to these drugs. This study will determine the degree of VEGF concentrations, response to anti-VEGF treatments, and determine biomarkers of inflammation as a means for explaining the cause of treatment resistance. Subsequently, another pathological process will be treated with spironolactone to see if the degree of contribution of choroidal hyperpermeability to the exudative process.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Spironolactone Treatment

Experimental

Patients with non-responsive Diabetic Macular Edema will be treated with Spironolactone in addition to the regular course of monthly aflibercept (Eylea).

干预措施: Spironolactone 50 mg (Drug)

结局指标

主要结局

Proportion of eyes with complete reabsorption of intraretinal fluid

时间窗: 1 year

Macular Edema - Volume

时间窗: 1 year

Macular volume

Macular Edema - Central Subgroup Thickening

时间窗: 1 year

Vision, best corrected, logMAR units

时间窗: 1 year

次要结局

  • Extrafoveal exudation (nCST)(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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