Central Serous ChorioretinopathyPhase 4NCT01574430
Study of Photodynamic Therapy (PDT) in Patients With Central Serous Chorioretinopathy (CSC)
A Phase 4 study testing PDT in people with Central Serous Chorioretinopathy, run by Peking University People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- PDT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Dec 2014
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with CSC
- patients signed the ICF
- patients with course of CSC less than 6 months
- patients did not undertake any treatment for CSC
Who cannot join
- patients with porphyria
- patients allergic to verteporfin
- pregnant or nursing women
- poor patients compliance
- sever liver dysfunction
- dioptric media opacities which make it difficult to exam fundus
Trial locations and contacts
1 site in 1 country.
China1 site
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044
About this study
Official title: A Randomized, Double-masked, Multicenter, Controlled Study of Photodynamic Therapy in Patients With Central Serous Chorioretinopathy
The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- PDT
- 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.
PDTProcedure or surgery
Also called photodynamic therapy
30% or 50% verteporfin dose PDT was given to patients with CSC
| Study group | Role | What they receive |
|---|---|---|
| 50% dose PDT | Active comparator | patients in this group was given 50% verteporfin dose PDT Receives: Procedure: PDT |
| 30% dose PDT | Experimental | patients in this group was given 30% verteporfin dose PDT Receives: Procedure: PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BCVA
Measured: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
Secondary outcomes (3)
Leakage at RPE level in FA
Measured: 1 week
Change from baseline in central retinal thickness
Measured: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
The incidence rate of adverse event
Measured: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingwei Zhao, Peking University People's Hospital
- Investigators
- Mingwei Zhao, M.D, Study director, Peking University People's HospitalYouxin Chen, M.D, Principal investigator, Peking Union Medical CollegeFeng Zhang, M.D, Principal investigator, Beijing Tongren Hospital of Capital Medical UniversityHong Dai, M.D, Principal investigator, Beijing HospitalXiaoxin Li, M.D, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574430
- Sponsor's protocol ID
- PDTCSC-CHINA
- Status last verified
- Aug 2016
- First submitted
- 8 Apr 2012
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.
PubMed 40522203Zhao M, Zhang F, Chen Y, Dai H, Qu J, Dong C, Kang X, Liu Y, Yang L, Li Y, Zhou P, Pan CT, Zhang L, Liu P, Zhou H, Jiao X, Xiong Y, Tian R, Lu Y, Yu X, Li X. A 50% vs 30% dose of verteporfin (photodynamic therapy) for acute central serous chorioretinopathy: one-year results of a randomized clinical trial. JAMA Ophthalmol. 2015 Mar;133(3):333-40. doi: 10.1001/jamaophthalmol.2014.5312.
PubMed 25555191
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Multicenter, Controlled Study of Photodynamic Therapy in Patients With Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT01574430
- Acronym / sponsor ID
- PDTCSC-CHINA
- Conditions
- Central Serous Chorioretinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Apr 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.
The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50% dose PDT | Active comparator | Procedure: PDTpatients in this group was given 50% verteporfin dose PDT |
| 30% dose PDT | Experimental | Procedure: PDTpatients in this group was given 30% verteporfin dose PDT |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with CSC
- patients signed the ICF
- patients with course of CSC less than 6 months
- patients did not undertake any treatment for CSC
Key exclusion criteria (6 listed)
- patients with porphyria
- patients allergic to verteporfin
- pregnant or nursing women
- poor patients compliance
- sever liver dysfunction
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 |
|---|---|---|
| PDTAlso: photodynamic therapy30% or 50% verteporfin dose PDT was given to patients with CSC | Procedure or surgery | 30% dose PDT, 50% dose PDT |
Primary outcome
Change from baseline in BCVA
Time frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
3 secondary outcomes
Leakage at RPE level in FA
Time frame: 1 week
Change from baseline in central retinal thickness
Time frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
The incidence rate of adverse event
Time frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year
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 16 Aug 2016.
- Derived from this study: PubMed 40522203Lange CA, Qureshi R, Pauleikhoff L. Interventions for central serous chorioretinopathy: a network meta-analysis. Cochrane Database Syst Rev. 2025 Jun 16;6(6):CD011841. doi: 10.1002/14651858.CD011841.pub3.
- Derived from this study: PubMed 25555191Zhao M, Zhang F, Chen Y, Dai H, Qu J, Dong C, Kang X, Liu Y, Yang L, Li Y, Zhou P, Pan CT, Zhang L, Liu P, Zhou H, Jiao X, Xiong Y, Tian R, Lu Y, Yu X, Li X. A 50% vs 30% dose of verteporfin (photodynamic therapy) for acute central serous chorioretinopathy: one-year results of a randomized clinical trial. JAMA Ophthalmol. 2015 Mar;133(3):333-40. doi: 10.1001/jamaophthalmol.2014.5312.
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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.
Mingwei Zhao, M.D study director
Peking University People's Hospital
Youxin Chen, M.D principal investigator
Peking Union Medical College
Feng Zhang, M.D principal investigator
Beijing Tongren Hospital of Capital Medical University
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 PDT in people with Central Serous Chorioretinopathy, run by Peking University People's Hospital at 1 site in China.
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 6 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 16 Aug 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 China. 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?
Change from baseline in BCVA (time frame: 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year). 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 NCT01574430, which also lists 2 linked publications.
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 Aug 2016.