Chronic Central Serous ChorioretinopathyPhase 4NCT02462499
Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
A Phase 4 study testing Inspra (eplerenone) in people with Chronic Central Serous Chorioretinopathy, run by Semmelweis University at 1 site in Hungary.
Trial summary
The aim of the study is to determine the efficacy and safety of treatment with the drug eplerenone in patients with chronic central serous chorioretinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Central Serous Chorioretinopathy
- What is being tested?
- Inspra (eplerenone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteHungary
- Study dates
- Jun 2014to Sep 2016
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic central serous chorioretinopathy (CSCR) with persistent subretinal fluid on OCT for more than 3 months after initial presentation .
- Written informed consent
Who cannot join
- Persons with impaired decision-making ability.
- Pregnant women or who are actively trying to conceive.
- Additional eye disease affecting the macula or posterior retina.
- Creatinine clearance < 50 ml/min
- Hyperkalemia > 5 mmol/l
- Serum creatinine > 2 mg/dl in men or > 1.8 mg/dl in women
Show all 9Show fewer
- Treatment with potassium sparing agents or potassium
- Treatment with any other drugs known to cause interaction with eplerenone
- Microalbuminuria in patients with type 2 diabetes
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Semmelweis University, Department of Ophthalmology
Budapest, 1085
About this study
The aim of the study is to determine the efficacy and safety of treatment with the drug eplerenone in patients with chronic central serous chorioretinopathy.
- Conditions
- Chronic Central Serous Chorioretinopathy
- Being tested
- Inspra (eplerenone)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspra (eplerenone)Drug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment: Eplerenone (Inspra) All patients will receive 25mg eplerenone once a day for a week, followed by 50mg once a day, for a total of 4-12 weeks. Receives: Drug: Inspra (eplerenone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of sub-retinal fluid measured by optical coherence tomography (OCT).
Measured: 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Measured: 3 months
Secondary outcomes (3)
Changes in macular volume at baseline, during and after the treatment with eplerenone.
Measured: 6 months
Changes in visual acuity at baseline measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, during and after the treatment with eplerenone.
Measured: 6 months
Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes.
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 posted4 Jun 2015 (estimated)
- Study startJun 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ecsedy, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462499
- Sponsor's protocol ID
- CSCR 104/2014
- Status last verified
- Oct 2016
- First submitted
- 26 May 2015
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eplerenone Treatment for Chronic Central Serous Chorioretinopathy in Hungarian Population
- ClinicalTrials.gov ID
- NCT02462499
- Acronym / sponsor ID
- CSCR 104/2014
- Conditions
- Chronic Central Serous Chorioretinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Jun 2015 (estimated)
- 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 aim of the study is to determine the efficacy and safety of treatment with the drug eplerenone in patients with chronic central serous chorioretinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Inspra (eplerenone)Treatment: Eplerenone (Inspra) All patients will receive 25mg eplerenone once a day for a week, followed by 50mg once a day, for a total of 4-12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic central serous chorioretinopathy (CSCR) with persistent subretinal fluid on OCT for more than 3 months after initial presentation .
- Written informed consent
Key exclusion criteria (9 listed)
- Persons with impaired decision-making ability.
- Pregnant women or who are actively trying to conceive.
- Additional eye disease affecting the macula or posterior retina.
- Creatinine clearance < 50 ml/min
- Hyperkalemia > 5 mmol/l
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 |
|---|---|---|
| Inspra (eplerenone) | Drug | Treatment |
Primary outcome
Resolution of sub-retinal fluid measured by optical coherence tomography (OCT).
Time frame: 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability.
Time frame: 3 months
3 secondary outcomes
Changes in macular volume at baseline, during and after the treatment with eplerenone.
Time frame: 6 months
Changes in visual acuity at baseline measured on Early Treatment of Diabetic Retinopathy Study (ETDRS) chart, during and after the treatment with eplerenone.
Time frame: 6 months
Changes in choroideal thickness at baseline measured by OCT, during and after the treatment with eplerenone in both eyes.
Time frame: 6 months
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 18 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for Chronic Central Serous Chorioretinopathy
Not yet recruitingPhase 2
Faricimab for Chronic Central Serous Chorioretinopathy: A Randomized Sham-Controlled Trial
Central Serous Chorioretinopathy (CSC)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inspra (eplerenone) in people with Chronic Central Serous Chorioretinopathy, run by Semmelweis University at 1 site in Hungary.
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 2 inclusion and 9 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 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Resolution of sub-retinal fluid measured by optical coherence tomography (OCT). (time frame: 6 months). The study lists 2 primary outcomes in all. 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 18 Oct 2016.