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临床试验/CTRI/2022/01/039632
CTRI/2022/01/039632招募中不适用

Efficacy of intravitreal dexamethasone injection in chronic, atypical, and recurrent central serous chorioretinopathy. A prospective pilot study.

Hyderabad Eye Research Foundation1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年1月31日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
1
主要终点
Change in intraocular pressure

研究概览

简要总结

Background: Central serous chorioretinopathy (CSC), characterized by an idiopathic serous neurosensory retinal detachment, has unclear pathogenesis. Choroidal hyperpermeability and retinal pigment epithelial (RPE) dysfunction have been suggested as possible mechanisms. While the benign nature of acute CSC is known, treatment challenges remain for chronic, atypical, and recurrent central serous chorioretinopathy because persistent fluid at macula results in permanent RPE damage and consequent vision loss. Treatment aims to preserve the outer neurosensory retinal layers and achieve complete resolution of the subretinal fluid (SRF) and intraretinal fluid (IRF), as even a tiny amount of remaining SRF can lead to irreversible damage to photoreceptors.

Both thermal and photochemical lasers like photodynamic therapy (PDT) have been advocated for treating these eyes. Chronic CSC (cCSC) with broad and indistinct leakage where thermal lasers are believed to be more damaging, PDT proves to be safer and efficacious in reducing SRF and improving visual acuity. But the non-availability of Verteporfin has forced retina surgeons to damaging thermal lasers in recent times. While both the interventions may result in RPE atrophy, PDT, in addition, may cause choroidal hypoperfusion and neovascular complications. Subthreshold lasers have also been tried in cCSC, but the need for confluent treatment spots in the absence of visible burns is a challenge.

Rationale: Dexamethasone has the highest relative clinical efficacy of any corticosteroid applied to ophthalmology practice and exerts its’ multiple effects via its’ influence on numerous signal transduction pathways. It has been approved for treating macular edema in retinal venous occlusions and non-infectious uveitis. Studies of diabetic macular edema treatment have demonstrated that dexamethasone implant may be an alternative treatment in recalcitrant edema owing to its’ anti-inflammatory, anti-permeability, and angiostatic effects. In age-related macular degeneration, anti-VEFG resistant choroidal neovascular complications responded well to a combination treatment of dexamethasone and anti-VEGF by improving retinal fluid resorption. CSC, a disease in which patients are advised to avoid corticosteroids in all forms anecdotal reports of Intravitreal triamcinolone injection have reported equivocal results. Intravitreal triamcinolone in chronic CSC, in a single case report, Jonas et al. did not find marked benefit, but Patron et al. showed complete resolution of cystoid changes secondary to cCSC.As dexamethasone implant as a rescue treatment in cCSC has never been tried in a prospective clinical study, we intend to determine its’ efficacy in chronic, atypical and recurrent central serous chorioretinopathy.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
46.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients with non-resolving and recurrent CSCR with focal, multifocal, or diffuse leaks on FA
  • Eyes with focal leaks within 1000microns of the center of fovea in chronic CSCR
  • Best corrected vision score of 73 to 34 at test distance of 4 meters on ETDRS chart at recruitment (Snellen equivalent 20/40 to 20/200)
  • Decrease in vision primarily secondary to CSCR
  • Willing to sign informed consent form.

排除标准

  • Laser or pharmacological treatment for CSCR in previous six months
  • Eyes with choroidal neovascularization demonstrated on OCTA/FA/ICGA
  • Fellow eye vision worse than 20/200
  • Patients with glaucoma.

结局指标

主要结局

Change in intraocular pressure

时间窗: 6 and 12 weeks

Complete resolution of SRF as determined on OCT

时间窗: 6 and 12 weeks

The disappearance of intraretinal cystoid spaces

时间窗: 6 and 12 weeks

Visual acuity change

时间窗: 6 and 12 weeks

Change in contrast sensitivity

时间窗: 6 and 12 weeks

Change in mfERG waveforms

时间窗: 6 and 12 weeks

次要结局

  • Reappearance of disease(% Requiring retreatment)

研究者

申办方类型
Research institution

研究点 (1)

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