NCT05104138

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

2.1 years

First QC Date

October 21, 2021

Last Update Submit

October 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Oral Eplerenone

Patients with central serous chorioretinopathy, treated by oral eplerenone

Drug: Eplerenone

Interventions

The patients underwent eplerenone treatment for 6 months

Also known as: Eplerenone in oral dose form
Oral Eplerenone

Half fluence photodynamic therapy for 6 months

Half fluence photodynamic therapy

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Interventions

EplerenoneDosage Forms

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Gilda Cennamo

    Università Federico II

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 2, 2021

Study Start

October 1, 2015

Primary Completion

October 30, 2017

Study Completion

November 30, 2017

Last Updated

November 2, 2021

Record last verified: 2021-10