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临床试验/NCT04224831
NCT04224831已完成不适用

Treatment of Chronic Recalcitrant or Unresponsive Central Serous Chorioretinopathy Via Electromagnetic Stimulation And Platelet- Rich Plasma

Ankara Universitesi Teknokent1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Sub-macular thickness

研究概览

简要总结

Purpose: To investigate the efficacy of combined use of retinal repetitive electromagnetic stimulation and subtenon autologous platelet-rich plasma in the treatment of recalcitrant or unresponsive chronic central serous chorioretinopathy.

详细描述

Central serous chorioretinopathy (CSCR) is a retinal disorder that is mostly unilateral, and predominantly affects young and middle-aged male patients who are otherwise healthy. It is characterized by leaking fluid through a dysfunctional retinal pigment epithelium (RPE) to submacular area resulting in serous neuroretinal detachment. The main risk factors for CSCR include emotional stress, systemic arterial hypertension, pregnancy, use of corticosteroids, and the presence of pachychoroid under the RPE layer.

Although several clinical presentations are described, two forms of CSCR can be distinguished: acute and chronic. Acute CSCR usually presents with sudden visual loss of central vision, disturbed color vision and dark adaptation, central or paracentral scotoma, metamorphopsia, and/or micropsia caused by the rapid accumulation of subretinal fluid (SRF). While spontaneous resolution is common and self-limiting with little or no residual damage in the acute variant, the chronic variant is usually progressive with persistence of SRF. Persistent serous detachment for more than 3 months can result in progressive photoreceptor (PR) compromise, which explains the worsening visual outcomes versus the acute form.

The chronic form of CSCR is characterized by diffuse multifocal irregular hyper-fluorescence seen on fluorescein angiography (FA) and indocyanine green angiography (ICGA) in addition to widespread RPE changes. B-scan optical coherence tompgraphy (OCT) shows elongated PR outer segments and a shallow heterogenous RPE detachment surrounded by subretinal fluid containing fibrin/fluorophore. Widespread diffuse RPE abnormalities including RPE atrophy, intraretinal fluid, and cystic retinal changes, retinal atrophy, subretinal fibrinous accumulation, subretinal fibrosis, and secondary choroidal neovascularization (CNV) are late complications that can lead to permanent visual loss.

The etiology of this disease remains incompletely understood with systemic associations and a complex pathogenesis that involves diffuse dysfunction of the RPE cells, the choroid, or both. Various treatment modalities have been used nowadays with varying success rates. These are selected according to the stage of the disease and diffusiveness and presence of CNV. Examples include acetazolamide, mineralocorticoid receptor antagonists, intravitreal anti-VEGF injections, photodynamic therapy (PDT), and subthreshold micropulse lasers (MPL). However, some of the CSCR cases are recalcitrant or unresponsive to currently available therapy modalities. The disease can be recurrent in 15-50% of cases or bilateral in approximately one-third of cases. Secondary CNV is an important vision-threatening complication of longstanding CSCR with an incidence ranging from 2% to 9%. Thus, new treatment options and approaches, addressing the complex nature of the etiopathogenesis are necessary in patients who would otherwise be disabled.

Platelets are anucleated cells containing many types of growth factors (GFs) such as epithelial growth factor (EGF), fibroblast growth factor (FGF), transforming growth factor (TGF), nerve growth factor (NGF), platelet-derived growth factor (PDGF), and insulin-like growth factor (IGF). These growth factors and their receptors are expressed in epithelial and endothelial cells and play a key role in tissue healing. EGF stimulates the proliferation and migration of epithelial cells. NGF is a neurotrophin that stimulates growth and survival of intraretinal glial cells, Müller's cells, and neurons; it can restore the function of injured neurons. NGF also plays a key role in the integrity and function of the both epithelial cells and nerve fibers. Autologous platelet-rich plasma (aPRP) that contains many GFs has been used to treat retinitis pigmentosa and deep retinal capillary ischemia with promising clinical functional and structural improvements.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The chronic CSCR cases included here meet one or more of the following criteria:
  • •Complaints of recurrent symptoms lasting longer than 3 months;
  • •Recalcitrant or unresponsive to all known current treatment modalities including PDT and MPL;
  • •Typical B-scan SD-OCT findings of chronicity such as elongation of photoreceptor outer segments indicating chronic nature of sub-macular fluid and/or the presence of serous flat-irregular RPED and focal areas of thickened RPE that lie below the collection of SRF;
  • •Widespread RPE/photoreceptor damage, RPE mottling and atrophy along with chronic submacular fluid;
  • •Widespread multifocal areas of chronic serous retinal detachment and/or flat-irregular RPEDs in those eyes that effective and reliable laser application is impossible.

排除标准

  • •Sub-threshold micro-pulse laser and/or photodynamic therapy applied in the last three months;
  • •Chronic CSCR complicated with secondary CNV.

研究组 & 干预措施

Before application

Active Comparator

The chronic CSCR cases included here meet one or more of the following criteria:

  • Complaints of recurrent symptoms lasting longer than 3 months;
  • Recalcitrant or unresponsive to all known current treatment modalities including PDT and MPL;
  • Typical B-scan SD-OCT findings of chronicity such as elongation of photoreceptor outer segments indicating chronic nature of sub-macular fluid and/or the presence of serous flat-irregular RPED and focal areas of thickened RPE that lie below the collection of SRF;
  • Widespread RPE/photoreceptor damage, RPE mottling and atrophy along with chronic submacular fluid;
  • Widespread multifocal areas of chronic serous retinal detachment and/or flat-irregular RPEDs in those eyes that effective and reliable laser application is impossible.

干预措施: Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresis (Combination Product)

After application

Active Comparator

The changes in SMT, CMT, DRCD, and BCVA before and after the interventions were compared.

干预措施: Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresis (Combination Product)

结局指标

主要结局

Sub-macular thickness

时间窗: Change from baseline sub-macular thickness at 1 months

This was measured manually from the ellipsoid zone to the Bruch's membrane in where sub-macular fluid is the thickest.

次要结局

  • Vessel densities of deep retinal capillary plexus(Change from baseline vessel densities of deep retinal capillary plexus at 1 months)

研究者

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

Umut Arslan

Principle investigator, MD

Ankara Universitesi Teknokent

研究点 (1)

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