Central Serous ChorioretinopathyNCT05589974
Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy
An observational study of Central Serous Chorioretinopathy, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
Patients with central serous chorioretinopathy (CSC) will be monitored with laser speckle flow graphy (LSFG), swept source optical coherence tomography (SS-OCT) and SS-OCT angiography (SS-OCTA). The aim is to unveil the flow and pulse wave characteristics of the choroidal circulation in acute CSC and chronic CSC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Verteporfin
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2022to 31 Jul 2026
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with acute or chronic CSC.
Who may be able to join
- Able to sign informed consent
- Possible to obtain fundus imaging
- Acute CSC ˂4 months of duration in one eye, defined as:
- Subfoveal presence of SRF on OCT
- Present attack is 1st -3rd attack of CSC
- Patient history and examination consistent with acute CSC c) Characteristic appearance of acute CSC on fundus autofluorescence (FAF) and OCT
Show all 11Show fewer
- Chronic CSC ≥4 months of duration in one eye, defined as:
- Subfoveal presence of SRF on OCT
- Subjective visual loss/symptoms
- Characteristic appearance of chronic CSC on FAF, fluorescein angiography (FA), and indocyanin angiography (ICGA) and OCT
- Patient history and examination consistent with chronic CSC
Who cannot join
- History of retinal disease other than CSC (e.g. retinal detachment)
- Contraindications for FA, ICGA or PDT (only for chronic CSC)
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Stavanger University Hospital, Department of Ophthalmology
Stavanger, 4016
Vegard Forsaa, MD, +47 48152212, vegard.forsaa@sus.no
Vegard Forsaa, PhD
About this study
Patients with central serous chorioretinopathy (CSC) will be monitored with laser speckle flow graphy (LSFG), swept source optical coherence tomography (SS-OCT) and SS-OCT angiography (SS-OCTA). The aim is to unveil the flow and pulse wave characteristics of the choroidal circulation in acute CSC and chronic CSC.
Read the detailed description
Acute CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics are related to the eventual resolution of subretinal fluid. Such relation can shed light on pathophysiological disease mechanisms and constitute a biomarker for disease activity.
Chronic CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics will change in response to standard treatment with PDT. The research of such changes will increase the understanding of the treatment response. This knowledge will help in the effort to understand the why some patients are non-responsive to the treatment.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Verteporfin
- 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.
VerteporfinDrug
Chronic CSC are receiving one treatment before the observation period.
| Study group | Role | What they receive |
|---|---|---|
| Acute | Patients with acute first attack CSC with subretinal fluid (SRF) on OCT and symptom duration under 4 months. | |
| Chronic | Patients with chronic CSC, i.e. symptoms and SRF for more than 4 months. Receives: Drug: Verteporfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean blur rate
Relative changes in choroidal blood flow
Measured: 6 months
Change in pulse wave form analysis
Changes in the shapes of pulse curves
Measured: 6 months
Secondary outcomes (2)
Change in choroidal density
Changes in the tissue density
Measured: 6 months
Change in choroidal thickness
Changes in the morphology of the choroid
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 posted21 Oct 2022
- Study start1 Oct 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Vegard Forsaa, MD PhD, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589974
- Sponsor's protocol ID
- REK485079
- Status last verified
- Nov 2023
- First submitted
- 20 Sep 2022
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study can be expanded as a multicenterstudy. I so, IPD will be shared among the study group.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT05589974
- Acronym / sponsor ID
- REK485079
- Conditions
- Central Serous Chorioretinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 21 Oct 2022 (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.
Patients with central serous chorioretinopathy (CSC) will be monitored with laser speckle flow graphy (LSFG), swept source optical coherence tomography (SS-OCT) and SS-OCT angiography (SS-OCTA). The aim is to unveil the flow and pulse wave characteristics of the choroidal circulation in acute CSC and chronic CSC.
Detailed description
Acute CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics are related to the eventual resolution of subretinal fluid. Such relation can shed light on pathophysiological disease mechanisms and constitute a biomarker for disease activity.
Chronic CSC - The proposed study tests the hypothesis that choroidal blood flow characteristics will change in response to standard treatment with PDT. The research of such changes will increase the understanding of the treatment response. This knowledge will help in the effort to understand the why some patients are non-responsive to the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute | – | –Patients with acute first attack CSC with subretinal fluid (SRF) on OCT and symptom duration under 4 months. |
| Chronic | – | Drug: VerteporfinPatients with chronic CSC, i.e. symptoms and SRF for more than 4 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with acute or chronic CSC.
Key inclusion criteria (11 listed)
- Able to sign informed consent
- Possible to obtain fundus imaging
- Acute CSC ˂4 months of duration in one eye, defined as:
- Chronic CSC ≥4 months of duration in one eye, defined as:
Key exclusion criteria (2 listed)
- History of retinal disease other than CSC (e.g. retinal detachment)
- Contraindications for FA, ICGA or PDT (only for chronic CSC)
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 |
|---|---|---|
| VerteporfinChronic CSC are receiving one treatment before the observation period. | Drug | Chronic |
Primary outcome
Change in mean blur rate
Time frame: 6 months
Relative changes in choroidal blood flow
Change in pulse wave form analysis
Time frame: 6 months
Changes in the shapes of pulse curves
2 secondary outcomes
Change in choroidal density
Time frame: 6 months
Change in choroidal thickness
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: Yes. This study can be expanded as a multicenterstudy. I so, IPD will be shared among the study group.
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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.
Vegard Forsaa, MD PhD principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Serous Chorioretinopathy, run by Helse Stavanger HF at 1 site in Norway.
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 11 inclusion and 2 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 18 Mar 2024. 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 Norway. 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.
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?
Contact Vegard Forsaa, MD PhD (+4748152212, forsaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean blur rate (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 Mar 2024.