Eplerenone Versus PDT: Comparative Study by OCTA

Completed

• Conditions: Central Serous Chorioretinopathy
• Interventions: Device: The patients underwent half fluence photodynamic therapy for 6 months; Drug: Eplerenone

• Registration Number: NCT05104138
• Lead Sponsor: Federico II University

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2017-10-30
• Study Completion: 2017-11-30
• Status Verified: 2021-10
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Last Update Submitted: 2021-10-21
• Study First Posted: 2021-11-02
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Half fluence photodynamic therapy	The patients underwent half fluence photodynamic therapy for 6 months	Patients with central serous chorioretinopathy, treated by half-fluence photodynamic therapy
Oral Eplerenone	Eplerenone	Patients with central serous chorioretinopathy, treated by oral eplerenone

Primary Outcome Measures

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