Chronic Central Serous ChorioretinopathyPhase 4SPECTNCT03079141
Photodynamic Therapy Versus Eplerenone: Treatment Trial for Chronic Central Serous Chorioretinopathy
A Phase 4 study testing Eplerenone and Photodynamic therapy in people with Chronic Central Serous Chorioretinopathy, run by Leiden University Medical Center at 3 sites in Netherlands.
Trial summary
Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye disease that is often diagnosed in patients in the professionally active age range. In this disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and the retinal pigment epithelium. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Central Serous Chorioretinopathy
- What is being tested?
- Eplerenone and Photodynamic therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 3 sitesNetherlands
- Study dates
- 20 Feb 2017to Aug 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age of ≥ 18 years of age and able to give written informed consent;
- Active chronic central serous chorioretinopathy (cCSC);
- Subjective visual loss > 6 weeks, interpreted as onset of active disease;
- Foveal subretinal fluid (SRF), on optical coherence tomography (OCT), at Baseline Examination;
- ≥1 ill-defined hyperfluorescent leakage areas on fluorescein angiography (FA) with retinal pigment epithelial window defect(s) that are compatible with cCSC;
- Hyperfluorescent areas on indocyanine green angiography (ICGA).
Who cannot join
- Any previous treatments for active CSC;
- Previous prescription of mineralocorticoid receptor antagonists, for cCSC or for other diseases;
- Current treatment with corticosteroids (topical or systemic), corticosteroid use within 3 months before possible start of trial treatment, or anticipated start of corticosteroid treatment within the first 2 years from the start of the trial period;
- Evidence of another diagnosis that can explain serous SRF or visual loss;
- Best-corrected visual acuity < 20/200 (Snellen equivalent);
- Profound chorioretinal atrophy in central macular area on ophthalmoscopy and OCT;
Show all 15Show fewer
- Myopia > 6D;
- Visual loss and/or serous detachment on OCT < 6 weeks;
- Continuous and/or progressive visual loss > 18 months or serous detachment on OCT > 18 months;
- No hyperfluorescence on ICGA;
- Intraretinal edema on OCT;
- (relative) Contraindications for FA or ICGA;
- (relative) Contraindications for photodynamic treatment (pregnancy, porphyria, severely disturbed liver function). Pregnancy will not be routinely tested in female patients, but the possibility of pregnancy will be discussed during screening
- (relative) Known contraindications for initiation of eplerenone treatment (hyperkalemia, abnormal renal clearance, severe hepatic insufficiency (Child-Pugh C), type 2 diabetes mellitus with microalbuminuria, concomitant use of potassium supplements, potassium-sparing diuretics, strong CYP3A4 inhibitors, or the combination of an ACE-inhibitor and an angiotensin receptor blocking agent). Pregnancy will not be routinely tested in female patients, but the possibility of pregnancy will be discussed during screening;
- Soft drusen in treated eye or fellow eye, signs of choroidal neovascularization on ophthalmoscopy and/or FA/ICGA of the study eye.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Academic Medical Center
Amsterdam
Leiden University Medical Center
Leiden
Radboud University Medical Center
Nijmegen
About this study
Official title: Study on Half-dose Photodynamic Therapy Versus Eplerenone in Chronic CenTRAl Serous Chorioretinopathy (SPECTRA Trial)
Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye disease that is often diagnosed in patients in the professionally active age range. In this disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and the retinal pigment epithelium. This specific form of macular degeneration can cause permanent vision loss, image distortion, and loss of color and contrast vision. An early diagnosis and treatment may improve the visual outcome and quality of life.
To date there is no international consensus on the optimal treatment of cCSC. Many retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in chronic CSC. Treatment with oral eplerenone may also be effective in this disease.
Read more
In this proposed prospective randomized controlled trial, cCSC patients will be randomized into one of both treatment groups: either half-dose PDT or oral eplerenone treatment. The trial is a superiority study, because retrospective studies suggest that PDT treatment may be more effective than eplerenone treatment.
The null hypothesis of the study is that PDT treatment is more effective than eplerenone treatment in patients with active cCSC. The alternative hypothesis is that PDT treatment is not superior to eplerenone treatment.
Treatment success will not only be based on characteristics on ophthalmological imaging, but also on functional endpoints (both on the outcome of questionnaires, best-corrected visual acuity, and microperimetry), which are most important from a patient's perspective.
The study will take place in 3 large tertiary referral university hospitals in The Netherlands that have extensive experience with conducting clinical trials (Academic Medical Center (Amsterdam, the Netherlands), Radboud University Medical Center (Nijmegen, the Netherlands), and Leiden University Medical Center (Leiden, the Netherlands). Both the Radboud University Medical Center and the Leiden University Medical Center have been involved in the first prospective randomized controlled trial that is currently conducted in cCSC.
This study will last 2 years per participant. Each participant will visit the outpatient clinic for a maximum number of 6 visits.
A total number of 107 patients will be included in the trial. Depending on the speed of inclusion of patients in this trial, the total duration of this study can be determined.
Read the detailed description
Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye disease that is often diagnosed in patients in the professionally active age range. In this disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and the retinal pigment epithelium. This specific form of macular degeneration can cause permanent vision loss, image distortion, and loss of color and contrast vision. An early diagnosis and treatment may improve the visual outcome and quality of life.
To date there is no international consensus on the optimal treatment of cCSC. Many retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in chronic CSC. Treatment with oral eplerenone may also be effective in this disease.
In this proposed prospective randomized controlled trial, cCSC patients will be randomized into one of both treatment groups: either half-dose PDT or oral eplerenone treatment. The trial is a superiority study, because retrospective studies suggest that PDT treatment may be more effective than eplerenone treatment.
The null hypothesis of the study is that PDT treatment is more effective than eplerenone treatment in patients with active cCSC. The alternative hypothesis is that PDT treatment is not superior to eplerenone treatment.
Treatment success will not only be based on characteristics on ophthalmological imaging, but also on functional endpoints (both on the outcome of questionnaires, best-corrected visual acuity, and microperimetry), which are most important from a patient's perspective.
The study will take place in 3 large tertiary referral university hospitals in The Netherlands that have extensive experience with conducting clinical trials (Academic Medical Center (Amsterdam, the Netherlands), Radboud University Medical Center (Nijmegen, the Netherlands), and Leiden University Medical Center (Leiden, the Netherlands). Both the Radboud University Medical Center and the Leiden University Medical Center have been involved in the first prospective randomized controlled trial that is currently conducted in cCSC.
This study will last 2 years per participant. Each participant will visit the outpatient clinic for a maximum number of 6 visits, depending on the outcome of treatment. Study evaluations will be mostly part of regular clinical care.
A total number of 107 patients will be included in the trial. Depending on the speed of inclusion of patients in this trial, the total duration of this study can be determined.
- Conditions
- Chronic Central Serous Chorioretinopathy
- Being tested
- Eplerenone, Photodynamic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Also called Inspra
Patients will receive 25 milligrams oral eplerenone once daily for a week, and - when no abnormalities during blood testing for potassium and renal clearance can be detected both before treatment and during the first week of treatment - will receive 50 milligrams oral eplerenone for another 11 weeks thereafter.
When patients are randomized to the eplerenone arm of this study, they will receive this treatment as a first cCSC treatment. Moreover, eplerenone treatment can be initiated in patients in whom SRF is still present on OCT at the Evaluation Visit at 3 months after PDT treatment.
Photodynamic therapyOther
In the PDT treatment arm, all patients will receive an intravenous drip through which half-dose (3 mg/m2) verteporfin (Visudyne®) is administered, with an infusion time of 10 minutes. At exactly 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689 nm, and a treatment duration of 83 seconds.
When patients are randomized to the PDT arm of this study, they will receive this treatment as a first cCSC treatment. Moreover, PDT can be performed in patients in whom SRF is still present on OCT at the Evaluation Visit at 3 months after the start of eplerenone treatment.
| Study group | Role | What they receive |
|---|---|---|
| Half-dose photodynamic therapy (PDT) | Active comparator | In the PDT treatment arm, all patients will receive an intravenous drip through which half-dose (3 mg/m2) verteporfin (Visudyne®) is administered, with an infusion time of 10 minutes. At exactly 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689 nm, and a treatment duration of 83 seconds.
When patients are randomized to the PDT arm of this study, they will receive this treatment as a first cCSC treatment. Moreover, PDT can be performed in patients in whom SRF is still present on OCT at the Evaluation Visit at 3 months after the start of eplerenone treatment. Receives: Other: Photodynamic therapy |
| Oral eplerenone treatment | Active comparator | Patients will receive 25 milligrams oral eplerenone once daily for a week, and - when no abnormalities during blood testing for potassium and renal clearance can be detected both before treatment and during the first week of treatment - will receive 50 milligrams oral eplerenone for another 11 weeks thereafter.
When patients are randomized to the eplerenone arm of this study, they will receive this treatment as a first cCSC treatment. Moreover, eplerenone treatment can be initiated in patients in whom SRF is still present on OCT at the Evaluation Visit at 3 months after PDT treatment. Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of subretinal fluid on OCT scan
Absence of subretinal fluid on OCT scan
Measured: 3 months after (start) of treatment
Secondary outcomes (6)
Macular sensitivity on microperimetry
Macular sensitivity on microperimetry
Measured: At evaluation visits during study, depending on the effect of treatment. All patients will visit the outpatient clinic at 3 months, at 1 year, and at 2 years after the (start of) treatment.
Mean change in best-corrected visual acuity
Mean change in Early Treatment of Diabetic Retinopathy Study best-corrected visual acuity
Measured: At evaluation visits during study, depending on the effect of treatment. All patients will visit the outpatient clinic at 3 months, at 1 year, and at 2 years after the (start of) treatment.
Vision-related quality of life as reported on the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)
Vision-related quality of life as reported on the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)
Measured: At evaluation visits during study, depending on the effect of treatment. All patients will visit the outpatient clinic at 3 months, at 1 year, and at 2 years after the (start of) treatment.
Number of cross-over treatments needed in each treatment arm
Number of cross-over treatments needed (half-dose photodynamic therapy to eplerenone treatment, and vice versa) in each treatment arm
Measured: During study. At the evaluation visit at 3 months after the (start of) treatment, a possible cross-over treatment can be performed.
The long-term outcome both after successful treatment and after non-successful treatment
Persistent absence of subretinal fluid on OCT
Measured: One year and two year after (start of) therapy
The number of (S)AEs in the 2 different treatment groups.
The number of (S)AEs in the 2 different treatment groups.
Measured: At the several evaluation visits within the study, at 3 months, at 1 year, and at 2 years after (the start of) treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start20 Feb 2017
- Primary completion28 Aug 2019
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Radboud University Medical Center
- Responsible party
- Principal investigator, CJFBoon, Leiden University Medical Center
- Investigators
- Camiel JF Boon, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079141
- Sponsor's protocol ID
- P16.255
- Acronym
- SPECT
- Status last verified
- Oct 2019
- First submitted
- 2 Mar 2017
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan.
Publications
Feenstra HMA, Diederen RMH, Lamme MJCM, Tsonaka R, Fauser S, Yzer S, van Rijssen T, Gkika T, Downes SM, Schlingemann RO, Hoyng CB, van Dijk EHC, Boon CJF. INCREASING EVIDENCE FOR THE SAFETY OF FOVEA-INVOLVING HALF-DOSE PHOTODYNAMIC THERAPY FOR CHRONIC CENTRAL SEROUS CHORIORETINOPATHY. Retina. 2023 Mar 1;43(3):379-388. doi: 10.1097/IAE.0000000000003686. Epub 2023 Jan 2.
PubMed 36727801
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Half-dose Photodynamic Therapy Versus Eplerenone in Chronic CenTRAl Serous Chorioretinopathy (SPECTRA Trial)
- ClinicalTrials.gov ID
- NCT03079141
- Acronym / sponsor ID
- SPECT / P16.255
- Conditions
- Chronic Central Serous Chorioretinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Radboud University Medical Center
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- Aug 2021 (estimated)
- First posted
- 14 Mar 2017 (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.
Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye disease that is often diagnosed in patients in the professionally active age range. In this disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and the retinal pigment epithelium. This specific form of macular degeneration can cause permanent vision loss, image distortion, and loss of color and contrast vision. An early diagnosis and treatment may improve the visual outcome and quality of life.
To date there is no international consensus on the optimal treatment of cCSC. Many retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in chronic CSC. Treatment with oral eplerenone may also be effective in this disease.
In this proposed prospective randomized controlled trial, cCSC patients will be randomized into one of both treatment groups: either half-dose PDT or oral eplerenone treatment. The trial is a superiority study, because retrospective studies suggest that PDT treatment may be more effective than eplerenone treatment.
The null hypothesis of the study is that PDT treatment is more effective than eplerenone treatment in patients with active cCSC. The alternative hypothesis is that PDT treatment is not superior to eplerenone treatment.
Treatment success will not only be based on characteristics on ophthalmological imaging, but also on functional endpoints (both on the outcome of questionnaires, best-corrected visual acuity, and microperimetry), which are most important from a patient's perspective.
The study will take place in 3 large tertiary referral university hospitals in The Netherlands that have extensive experience with conducting clinical trials (Academic Medical Center (Amsterdam, the Netherlands), Radboud University Medical Center (Nijmegen, the Netherlands), and Leiden University Medical Center (Leiden, the Netherlands). Both the Radboud University Medical Center and the Leiden University Medical Center have been involved in the first prospective randomized controlled trial that is currently conducted in cCSC.
This study will last 2 years per participant. Each participant will visit the outpatient clinic for a maximum number of 6 visits.
A total number of 107 patients will be included in the trial. Depending on the speed of inclusion of patients in this trial, the total duration of this study can be determined.
Detailed description
Chronic central serous chorioretinopathy (cCSC) is a relatively frequently occurring eye disease that is often diagnosed in patients in the professionally active age range. In this disease, a subretinal fluid accumulation occurs, due to abnormalities in both the choroid and the retinal pigment epithelium. This specific form of macular degeneration can cause permanent vision loss, image distortion, and loss of color and contrast vision. An early diagnosis and treatment may improve the visual outcome and quality of life.
To date there is no international consensus on the optimal treatment of cCSC. Many retrospective studies suggest that treatment with photodynamic therapy (PDT) is effective in chronic CSC. Treatment with oral eplerenone may also be effective in this disease.
In this proposed prospective randomized controlled trial, cCSC patients will be randomized into one of both treatment groups: either half-dose PDT or oral eplerenone treatment. The trial is a superiority study, because retrospective studies suggest that PDT treatment may be more effective than eplerenone treatment.
The null hypothesis of the study is that PDT treatment is more effective than eplerenone treatment in patients with active cCSC. The alternative hypothesis is that PDT treatment is not superior to eplerenone treatment.
Treatment success will not only be based on characteristics on ophthalmological imaging, but also on functional endpoints (both on the outcome of questionnaires, best-corrected visual acuity, and microperimetry), which are most important from a patient's perspective.
The study will take place in 3 large tertiary referral university hospitals in The Netherlands that have extensive experience with conducting clinical trials (Academic Medical Center (Amsterdam, the Netherlands), Radboud University Medical Center (Nijmegen, the Netherlands), and Leiden University Medical Center (Leiden, the Netherlands). Both the Radboud University Medical Center and the Leiden University Medical Center have been involved in the first prospective randomized controlled trial that is currently conducted in cCSC.
This study will last 2 years per participant. Each participant will visit the outpatient clinic for a maximum number of 6 visits, depending on the outcome of treatment. Study evaluations will be mostly part of regular clinical care.
A total number of 107 patients will be included in the trial. Depending on the speed of inclusion of patients in this trial, the total duration of this study can be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Half-dose photodynamic therapy (PDT) | Active comparator | Other: Photodynamic therapyIn the PDT treatment arm, all patients will receive an intravenous drip through which half-dose (3 mg/m2) verteporfin (Visudyne®) is administered, with an infusion time of 10 minutes. At exactly 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689 nm, and a treatment duration of 83 seconds. When patients are randomized to the PDT arm of this study, they will receive this treatment as a first cCSC treatment. Moreover, PDT can be performed in patients in whom SRF is still present on OCT at the Evaluation Visit at 3 months after the start of eplerenone treatment. |
| Oral eplerenone treatment | Active comparator | Drug: EplerenonePatients will receive 25 milligrams oral eplerenone once daily for a week, and - when no abnormalities during blood testing for potassium and renal clearance can be detected both before treatment and during the first week of treatment - will receive 50 milligrams oral eplerenone for another 11 weeks thereafter. When patients are randomized to the eplerenone arm of this study, they will receive this treatment as a first cCSC treatment. Moreover, eplerenone treatment can be initiated in patients in whom SRF is still present on OCT at the Evaluation Visit at 3 months after PDT treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age of ≥ 18 years of age and able to give written informed consent;
- Active chronic central serous chorioretinopathy (cCSC);
- Subjective visual loss > 6 weeks, interpreted as onset of active disease;
- Foveal subretinal fluid (SRF), on optical coherence tomography (OCT), at Baseline Examination;
- ≥1 ill-defined hyperfluorescent leakage areas on fluorescein angiography (FA) with retinal pigment epithelial window defect(s) that are compatible with cCSC;
Key exclusion criteria (15 listed)
- Any previous treatments for active CSC;
- Previous prescription of mineralocorticoid receptor antagonists, for cCSC or for other diseases;
- Current treatment with corticosteroids (topical or systemic), corticosteroid use within 3 months before possible start of trial treatment, or anticipated start of corticosteroid treatment within the first 2 years from the start of the trial period;
- Evidence of another diagnosis that can explain serous SRF or visual loss;
- Best-corrected visual acuity < 20/200 (Snellen equivalent);
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: InspraPatients will receive 25 milligrams oral eplerenone once daily for a week, and - when no abnormalities during blood testing for potassium and renal clearance can be detected both before treatment and during the first week of treatment - will receive 50 milligrams oral eplerenone for another 11 weeks thereafter. When patients are randomized to the eplerenone arm of this study, they will receive this treatment as a first cCSC treatment. Moreover, eplerenone treatment can be initiated in patients in whom SRF is still present on OCT at the Evaluation Visit at 3 months after PDT treatment. | Drug | Oral eplerenone treatment |
| Photodynamic therapyIn the PDT treatment arm, all patients will receive an intravenous drip through which half-dose (3 mg/m2) verteporfin (Visudyne®) is administered, with an infusion time of 10 minutes. At exactly 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689 nm, and a treatment duration of 83 seconds. When patients are randomized to the PDT arm of this study, they will receive this treatment as a first cCSC treatment. Moreover, PDT can be performed in patients in whom SRF is still present on OCT at the Evaluation Visit at 3 months after the start of eplerenone treatment. | Other | Half-dose photodynamic therapy (PDT) |
Primary outcome
Absence of subretinal fluid on OCT scan
Time frame: 3 months after (start) of treatment
Absence of subretinal fluid on OCT scan
6 secondary outcomes
Macular sensitivity on microperimetry
Time frame: At evaluation visits during study, depending on the effect of treatment. All patients will visit the outpatient clinic at 3 months, at 1 year, and at 2 years after the (start of) treatment.
Mean change in best-corrected visual acuity
Time frame: At evaluation visits during study, depending on the effect of treatment. All patients will visit the outpatient clinic at 3 months, at 1 year, and at 2 years after the (start of) treatment.
Vision-related quality of life as reported on the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25)
Time frame: At evaluation visits during study, depending on the effect of treatment. All patients will visit the outpatient clinic at 3 months, at 1 year, and at 2 years after the (start of) treatment.
Number of cross-over treatments needed in each treatment arm
Time frame: During study. At the evaluation visit at 3 months after the (start of) treatment, a possible cross-over treatment can be performed.
The long-term outcome both after successful treatment and after non-successful treatment
Time frame: One year and two year after (start of) therapy
The number of (S)AEs in the 2 different treatment groups.
Time frame: At the several evaluation visits within the study, at 3 months, at 1 year, and at 2 years after (the start of) treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Derived from this study: PubMed 36727801Feenstra HMA, Diederen RMH, Lamme MJCM, Tsonaka R, Fauser S, Yzer S, van Rijssen T, Gkika T, Downes SM, Schlingemann RO, Hoyng CB, van Dijk EHC, Boon CJF. INCREASING EVIDENCE FOR THE SAFETY OF FOVEA-INVOLVING HALF-DOSE PHOTODYNAMIC THERAPY FOR CHRONIC CENTRAL SEROUS CHORIORETINOPATHY. Retina. 2023 Mar 1;43(3):379-388. doi: 10.1097/IAE.0000000000003686. Epub 2023 Jan 2.
- Individual participant dataSharing planned: No. No plan.
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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.
Camiel JF Boon, MD, PhD principal investigator
Leiden University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eplerenone and Photodynamic therapy in people with Chronic Central Serous Chorioretinopathy, run by Leiden University Medical Center at 3 sites in Netherlands.
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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Results are not available in the source record.
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?
Absence of subretinal fluid on OCT scan (time frame: 3 months after (start) of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079141, which also lists 1 linked publication.
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 23 Oct 2019.