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NCT Number: NCT05104138

Eplerenone Versus PDT: Comparative Study by OCTA

The study aims to analyze the changes in OCTA parameters and in choroidal thickness in patients affected by central serous chorioretinopathy treated by oral eplerenone and half-fluence photodynamic therapy.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

Central serous chorioretinopathy (CSC) is a chorioretinal disease characterized by serous detachment due to the dilatation and hyperpermeability of choroidal vessels resulting in the accumulation of serous fluid between the neurosensory retina and the retinal pigment epithelium.

Several studies reported the efficacy of half-fluence photodynamic therapy (PDT) and oral eplerenone in the CSC treatment inducing a reduction of the choroidal hyperpermeability and remodeling the choroidal vascularization.

This retrospective study aims to perform a quantitative analysis of retinal and CC vessel density by OCTA at baseline, 3 and 6 months in patients underwent PDT and patients underwent eplerenone.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age older than 30 years
  • diagnosis of central serous chorioretinopathy
  • treatment-naïve with half-fluence photodynamic therapy or oral eplerenone
  • absence of vitreoretinal and vascular retinal diseases

Exclusion criteria

  • age younger than 30 years
  • absence of diagnosis of central serous chorioretinopathy
  • previous treatment with half-fluence photodynamic therapy or oral eplerenone
  • presence of concomitant vitreoretinal and vascular retinal diseases

Treatment and study plan

Eplerenone

Drug

The patients underwent eplerenone treatment for 6 months

Other names: Eplerenone in oral dose form

The patients underwent half fluence photodynamic therapy for 6 months

Device

Half fluence photodynamic therapy for 6 months

Primary outcomes

  1. Study of vessel density in retinal choriocapillaris networks, using OCTA, in patients underwent half fluence photodynamic therapy and oral eplerenone

    Time frame: 6 months

    To evaluate the role of optical coherence tomography angiography in predicting the changes of the vessel density of retinal and choriocapillaris vascular networks , comparing patients underwent half-fluence phodynamic therapy and patients with oral eplerenone.

    The vessel density are expressed as percentage

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

OCTA in Central Serous Chorioratinopathy Treated With Oral Eplerenone or Hal-fluence Photodynamic Therapy: a Comparative Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2021
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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