Central Serous ChorioretinopathyNCT05104138
Eplerenone Versus PDT: Comparative Study by OCTA
An observational study of Central Serous Chorioretinopathy, run by Federico II University.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Eplerenone and The patients underwent half fluence photodynamic therapy for 6 months
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 30 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Adult
Study population: The participans were older than 40 years with central serous chorioretinopathy. They did not present other ophthalmological diseases
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Eplerenone, The patients underwent half fluence photodynamic therapy for 6 months
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Also called Eplerenone in oral dose form
The patients underwent eplerenone treatment for 6 months
The patients underwent half fluence photodynamic therapy for 6 monthsDevice
Half fluence photodynamic therapy for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Half fluence photodynamic therapy | Patients with central serous chorioretinopathy, treated by half-fluence photodynamic therapy Receives: Device: The patients underwent half fluence photodynamic therapy for 6 months | |
| Oral Eplerenone | Patients with central serous chorioretinopathy, treated by oral eplerenone Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start1 Oct 2015
- Primary completion30 Oct 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilda Cennamo, Federico II University
- Investigators
- Gilda Cennamo, Principal investigator, Università Federico II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104138
- Sponsor's protocol ID
- 1010/2021
- Status last verified
- Oct 2021
- First submitted
- 21 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCTA in Central Serous Chorioratinopathy Treated With Oral Eplerenone or Hal-fluence Photodynamic Therapy: a Comparative Study
- ClinicalTrials.gov ID
- NCT05104138
- Acronym / sponsor ID
- 1010/2021
- Conditions
- Central Serous Chorioretinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Half fluence photodynamic therapy | – | Device: The patients underwent half fluence photodynamic therapy for 6 monthsPatients with central serous chorioretinopathy, treated by half-fluence photodynamic therapy |
| Oral Eplerenone | – | Drug: EplerenonePatients with central serous chorioretinopathy, treated by oral eplerenone |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- The participans were older than 40 years with central serous chorioretinopathy. They did not present other ophthalmological diseases
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EplerenoneAlso: Eplerenone in oral dose formThe patients underwent eplerenone treatment for 6 months | Drug | Oral Eplerenone |
| The patients underwent half fluence photodynamic therapy for 6 monthsHalf fluence photodynamic therapy for 6 months | Device | Half fluence photodynamic therapy |
Primary outcome
Study of vessel density in retinal choriocapillaris networks, using OCTA, in patients underwent half fluence photodynamic therapy and oral eplerenone
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilda Cennamo principal investigator
Università Federico II
Questions about this trial
What is this clinical trial studying?
An observational study of Central Serous Chorioretinopathy, run by Federico II University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of vessel density in retinal choriocapillaris networks, using OCTA, in patients underwent half fluence photodynamic therapy and oral eplerenone (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.