Eplerenone Versus PDT: Comparative Study by OCTA

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

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.

Study Overview

• Status: Completed
• Conditions: Central Serous Chorioretinopathy
• Intervention / Treatment: Device: The patients underwent half fluence photodynamic therapy for 6 months; Drug: Eplerenone

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 Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participans were older than 40 years with central serous chorioretinopathy. They did not present other ophthalmological diseases

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study of vessel density in retinal choriocapillaris networks, using OCTA, in patients underwent half fluence photodynamic therapy and oral eplerenone	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	6 months

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Gilda Cennamo, Università Federico II

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): October 30, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Actual): November 2, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Central Serous Chorioretinopathy; Physiological Effects of Drugs; Antihypertensive Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Natriuretic Agents; Diuretics; Hormone Antagonists; Mineralocorticoid Receptor Antagonists; Diuretics, Potassium Sparing; Eplerenone
• Other Study ID Numbers: 1010/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No