Eplerenone Versus PDT: Comparative Study by OCTA

Sponsor

Federico II University (Other)

Overall Status

Completed

CT.gov ID

NCT05104138

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Central Serous Chorioretinopathy	Drug: Eplerenone Device: The patients underwent half fluence photodynamic therapy for 6 months

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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Oct 30, 2017

Actual Study Completion Date :

Nov 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Half fluence photodynamic therapy Patients with central serous chorioretinopathy, treated by half-fluence photodynamic therapy	Device: The patients underwent half fluence photodynamic therapy for 6 months Half fluence photodynamic therapy for 6 months
Oral Eplerenone Patients with central serous chorioretinopathy, treated by oral eplerenone	Drug: Eplerenone The patients underwent eplerenone treatment for 6 months Other Names: Eplerenone in oral dose form

Arm

Intervention/Treatment

Half fluence photodynamic therapy

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

Device: The patients underwent half fluence photodynamic therapy for 6 months

Half fluence photodynamic therapy for 6 months

Oral Eplerenone

Patients with central serous chorioretinopathy, treated by oral eplerenone

Drug: Eplerenone

The patients underwent eplerenone treatment for 6 months

Other Names:

Eplerenone in oral dose form

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Federico II University

Investigators

Principal Investigator: Gilda Cennamo, Università Federico II

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gilda Cennamo, Principal Investigator, Federico II University

ClinicalTrials.gov Identifier:

NCT05104138

Other Study ID Numbers:

1010/2021

First Posted:

Nov 2, 2021

Last Update Posted:

Nov 2, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Central Serous Chorioretinopathy

Eplerenone

Study Results

No Results Posted as of Nov 2, 2021