Eplerenone Versus PDT: Comparative Study by OCTA

NCT ID: NCT05104138

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-01

Study Completion Date

2017-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Central Serous Chorioretinopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Half fluence photodynamic therapy

Patients with central serous chorioretinopathy, treated by half-fluence photodynamic therapy

The patients underwent half fluence photodynamic therapy for 6 months

Intervention Type DEVICE

Half fluence photodynamic therapy for 6 months

Oral Eplerenone

Patients with central serous chorioretinopathy, treated by oral eplerenone

Eplerenone

Intervention Type DRUG

The patients underwent eplerenone treatment for 6 months

Interventions

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Eplerenone

The patients underwent eplerenone treatment for 6 months

Intervention Type DRUG

The patients underwent half fluence photodynamic therapy for 6 months

Half fluence photodynamic therapy for 6 months

Intervention Type DEVICE

Other Intervention Names

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Eplerenone in oral dose form

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Gilda Cennamo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gilda Cennamo

Role: PRINCIPAL_INVESTIGATOR

Università Federico II

Other Identifiers

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1010/2021

Identifier Type: -

Identifier Source: org_study_id