Central Serous ChorioretinopathyNCT01630863
The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
A study testing Photodynamic therapy in people with Central Serous Chorioretinopathy, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
To find the safe effective lowest light dose for photodynamic therapy (PDT). in the treatment of central serous chorioretinopathy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Photodynamic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Mar 2015
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
- Presence of SRF and/or serous pigment epithelial detachment on optical coherence tomography (OCT)
- Presence of abnormal dilated choroidal vasculature in ICGA
- Patients with symptomatic CSC of at least 3 months duration
Who cannot join
- Patients who received any previous treatment, including PDT or focal thermal laser photocoagulation for CSC, or who had evidence of CNV, PCV, or other maculopathy on clinical examination, FA, or ICGA
- Patients receiving exogenous corticosteroid treatment
- Patients with systemic diseases such as Cushing's disease or renal diseases
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yeungnam University College of Medicine
Daegu
Min Sagong, 82-53-620-4191, msagong@ynu.ac.kr
Min Sagong
About this study
To find the safe effective lowest light dose for photodynamic therapy (PDT). in the treatment of central serous chorioretinopathy.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Photodynamic therapy
- Keywords
- Central serous chorioretinopathy, photodynamic therapy, safe and effective dose
- 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.
Photodynamic therapyProcedure or surgery
Photodynamic therapy is performed using verteporfin. Full dose of verteporfin is infused for 10 minutes, followed by laser delivery at 15 minutes from the start of infusion. Different light dose of PDT is applied to the patients at 50%, 40% and 30% of the full energy based on TAP study. The area of irradiation is set to the abnormal choroidal vascular hyperpermeability on ICGA corresponding to the leaking area on FA.
| Study group | Role | What they receive |
|---|---|---|
| 50% group | Experimental | power of PDT is applied to the patients at 50% of the full energy based on TAP study. Receives: Procedure: Photodynamic therapy |
| 40% group | Experimental | Decreasing power of PDT is applied to the patients at 40% of the full energy based on TAP study. Receives: Procedure: Photodynamic therapy |
| 30% group | Experimental | Decreasing power of PDT is applied to the patients at 30% of the full energy based on TAP study. Receives: Procedure: Photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of best corrected visual acuity
Changes of best corrected visual acuity at baseline and 1, 3, 6 month after PDT
Measured: 6 month
Secondary outcomes (1)
Change of central retinal thickness, success rate, recurrence rate, and complications
Change of the central retinal thickness on optical coherence tomography (OCT)are compared at baseline at 1, 3, and 6 months after PDT. Additionally, success rate, recurrence rate, and complications between three groups are evaluated during 6 months.
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 posted28 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2014
- Study completionMar 2015 (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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Sagong, Yeungnam University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630863
- Sponsor's protocol ID
- YUH-12-007-D4
- Status last verified
- Feb 2015
- First submitted
- 26 Jun 2012
- Last updated
- 16 Feb 2015
- Results posted
- No
Publications
Park DG, Jeong S, Noh D, Sagong M. Optimal fluence rate of photodynamic therapy for chronic central serous chorioretinopathy. Br J Ophthalmol. 2021 Jun;105(6):844-849. doi: 10.1136/bjophthalmol-2020-316837. Epub 2020 Jul 29.
PubMed 32727733
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safe Effective Light Dose of Photodynamic Therapy for Chronic Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT01630863
- Acronym / sponsor ID
- YUH-12-007-D4
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- Central serous chorioretinopathy, photodynamic therapy, safe and effective dose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 28 Jun 2012 (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.
To find the safe effective lowest light dose for photodynamic therapy (PDT). in the treatment of central serous chorioretinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50% group | Experimental | Procedure: Photodynamic therapypower of PDT is applied to the patients at 50% of the full energy based on TAP study. |
| 40% group | Experimental | Procedure: Photodynamic therapyDecreasing power of PDT is applied to the patients at 40% of the full energy based on TAP study. |
| 30% group | Experimental | Procedure: Photodynamic therapyDecreasing power of PDT is applied to the patients at 30% of the full energy based on TAP study. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic detachment of the neurosensory retina with a focal leak at the level of the RPE with FA
- Presence of SRF and/or serous pigment epithelial detachment on optical coherence tomography (OCT)
- Presence of abnormal dilated choroidal vasculature in ICGA
- Patients with symptomatic CSC of at least 3 months duration
Key exclusion criteria (4 listed)
- Patients who received any previous treatment, including PDT or focal thermal laser photocoagulation for CSC, or who had evidence of CNV, PCV, or other maculopathy on clinical examination, FA, or ICGA
- Patients receiving exogenous corticosteroid treatment
- Patients with systemic diseases such as Cushing's disease or renal diseases
- Pregnant patients
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 |
|---|---|---|
| Photodynamic therapyPhotodynamic therapy is performed using verteporfin. Full dose of verteporfin is infused for 10 minutes, followed by laser delivery at 15 minutes from the start of infusion. Different light dose of PDT is applied to the patients at 50%, 40% and 30% of the full energy based on TAP study. The area of irradiation is set to the abnormal choroidal vascular hyperpermeability on ICGA corresponding to the leaking area on FA. | Procedure or surgery | 30% group, 40% group, 50% group |
Primary outcome
Changes of best corrected visual acuity
Time frame: 6 month
Changes of best corrected visual acuity at baseline and 1, 3, 6 month after PDT
1 secondary outcome
Change of central retinal thickness, success rate, recurrence rate, and complications
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 16 Feb 2015.
- Derived from this study: PubMed 32727733Park DG, Jeong S, Noh D, Sagong M. Optimal fluence rate of photodynamic therapy for chronic central serous chorioretinopathy. Br J Ophthalmol. 2021 Jun;105(6):844-849. doi: 10.1136/bjophthalmol-2020-316837. Epub 2020 Jul 29.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photodynamic therapy in people with Central Serous Chorioretinopathy, run by Yeungnam University College of Medicine at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 16 Feb 2015. 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 South Korea. 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 Min Sagong (82-53-620-4191, msagong@ynu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of best corrected visual acuity (time frame: 6 month). 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 NCT01630863, 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 16 Feb 2015.