Eplerenone Versus PDT: Comparative Study by OCTA

Central Serous Chorioretinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104138
• Other study ID #: 1010/2021
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: November 30, 2017

Study information

• Verified date: October 2021
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2017
• Est. primary completion date: October 30, 2017
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Drug:
• Eplerenone
The patients underwent eplerenone treatment for 6 months

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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