Central Serous ChorioretinopathyNCT05390619
Different Doses of vPDT in the Treatment of cCSC
A study testing 50% dose of photodynamic therapy and 70% dose of photodynamic therapy in people with Central Serous Chorioretinopathy and Therapy, Photodynamic, run by Peking University People's Hospital at 1 site in China.
Trial summary
This is a prospective, randomized and controlled clinical trial of photodynamic therapy (PDT) for chronic central serous chorioretinopathy (CSC). The patients who met the inclusion criteria were randomly divided into 50% dose PDT treatment group and 70% dose PDT treatment group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Central Serous Chorioretinopathy, Therapy, Photodynamic
- What is being tested?
- 50% dose of photodynamic therapy and 70% dose of 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old, regardless of gender;
- Meet the diagnostic criteria of central serous chorioretinopathy;
- The course of CSC (subject to the symptoms of this disease) is more than 3 months;
- Patients with simultaneous diseases of both eyes were included in those with more subretinal fluid.
Who cannot join
- macular neuroretinal detachment caused by rhegmatogenous retinal detachment, uveitis, age-related macular degeneration, polypoid choroidal angiopathy and other fundus diseases;
- a previous history of PDT treatment;
- systemic hormone or local hormone nasal spray is being used, or hormone is stopped for less than 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yuou Yao, Dr, yaoyoyo19@139.com
About this study
Official title: Comparison of Different Doses of Verteporfin Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
This is a prospective, randomized and controlled clinical trial of photodynamic therapy (PDT) for chronic central serous chorioretinopathy (CSC). The patients who met the inclusion criteria were randomly divided into 50% dose PDT treatment group and 70% dose PDT treatment group. The primary treatment success rate and adverse event rate of the two groups were compared by optical coherence tomography (OCT), and then the best PDT treatment scheme for chronic CSC was summarized.
- Being tested
- 50% dose of photodynamic therapy, 70% dose of photodynamic therapy
- 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.
50% dose of photodynamic therapyProcedure or surgery
Verteporfin (Visudyne; Novartis, Switzerland) was administrated intravenously over 10 minutes with 50% doses based on the randomization . Fifteen minutes after commencing the verteporfin infusion, a contact lens (Volk® area centralis) was positioned on the affected eye, the treatment area was exposed to a 689 nm laser with a fluence of 600 mw/cm2 for 83 seconds and a total laser energy of 50 J/cm2.
70% dose of photodynamic therapyProcedure or surgery
Verteporfin (Visudyne; Novartis, Switzerland) was administrated intravenously over 10 minutes with 70% doses based on the randomization . Fifteen minutes after commencing the verteporfin infusion, a contact lens (Volk® area centralis) was positioned on the affected eye, the treatment area was exposed to a 689 nm laser with a fluence of 600 mw/cm2 for 83 seconds and a total laser energy of 50 J/cm2.
| Study group | Role | What they receive |
|---|---|---|
| 50% dose of PDT | Experimental | Patients received 50% dose of verteporfin PDT therapy. Receives: Procedure: 50% dose of photodynamic therapy |
| 70% dose of PDT | Experimental | Patients received 70% dose of verteporfin PDT therapy. Receives: Procedure: 70% dose of photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete absorption rate of subretinal fluid
The absorption of subretinal fluid was observed on optical coherence tomography at each follow up visit
Measured: 3 months after the primary PDT
Secondary outcomes (3)
Central foveal thickness change after the PDT
The hight of central foveal thickness was measured on optical coherence tomography at each visit
Measured: 12 months after the PDT
Subfoveal choroidal thickness change after the PDT
The hight of Subfoveal choroidal thickness was measured on optical coherence tomography at each visit
Measured: 12 months after the PDT
Best corrected visual acuity change after the PDT
The BCVA was tested at each visit
Measured: 12 months after the PDT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao Yiou, Peking University People's Hospital
- Investigators
- Yuou Yao, Dr, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390619
- Sponsor's protocol ID
- RDL2020-04
- Status last verified
- May 2022
- First submitted
- 17 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Doses of Verteporfin Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT05390619
- Acronym / sponsor ID
- RDL2020-04
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 May 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.
This is a prospective, randomized and controlled clinical trial of photodynamic therapy (PDT) for chronic central serous chorioretinopathy (CSC). The patients who met the inclusion criteria were randomly divided into 50% dose PDT treatment group and 70% dose PDT treatment group. The primary treatment success rate and adverse event rate of the two groups were compared by optical coherence tomography (OCT), and then the best PDT treatment scheme for chronic CSC was summarized.
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 of PDT | Experimental | Procedure: 50% dose of photodynamic therapyPatients received 50% dose of verteporfin PDT therapy. |
| 70% dose of PDT | Experimental | Procedure: 70% dose of photodynamic therapyPatients received 70% dose of verteporfin PDT therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years old, regardless of gender;
- Meet the diagnostic criteria of central serous chorioretinopathy;
- The course of CSC (subject to the symptoms of this disease) is more than 3 months;
- Patients with simultaneous diseases of both eyes were included in those with more subretinal fluid.
Key exclusion criteria (3 listed)
- macular neuroretinal detachment caused by rhegmatogenous retinal detachment, uveitis, age-related macular degeneration, polypoid choroidal angiopathy and other fundus diseases;
- a previous history of PDT treatment;
- systemic hormone or local hormone nasal spray is being used, or hormone is stopped for less than 3 months.
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 |
|---|---|---|
| 50% dose of photodynamic therapyVerteporfin (Visudyne; Novartis, Switzerland) was administrated intravenously over 10 minutes with 50% doses based on the randomization . Fifteen minutes after commencing the verteporfin infusion, a contact lens (Volk® area centralis) was positioned on the affected eye, the treatment area was exposed to a 689 nm laser with a fluence of 600 mw/cm2 for 83 seconds and a total laser energy of 50 J/cm2. | Procedure or surgery | 50% dose of PDT |
| 70% dose of photodynamic therapyVerteporfin (Visudyne; Novartis, Switzerland) was administrated intravenously over 10 minutes with 70% doses based on the randomization . Fifteen minutes after commencing the verteporfin infusion, a contact lens (Volk® area centralis) was positioned on the affected eye, the treatment area was exposed to a 689 nm laser with a fluence of 600 mw/cm2 for 83 seconds and a total laser energy of 50 J/cm2. | Procedure or surgery | 70% dose of PDT |
Primary outcome
The complete absorption rate of subretinal fluid
Time frame: 3 months after the primary PDT
The absorption of subretinal fluid was observed on optical coherence tomography at each follow up visit
3 secondary outcomes
Central foveal thickness change after the PDT
Time frame: 12 months after the PDT
Subfoveal choroidal thickness change after the PDT
Time frame: 12 months after the PDT
Best corrected visual acuity change after the PDT
Time frame: 12 months after the PDT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
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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.
Yuou Yao, Dr study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50% dose of photodynamic therapy and 70% dose of photodynamic therapy in people with Central Serous Chorioretinopathy and Therapy, Photodynamic, 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 3 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 25 May 2022. 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.
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 Yuou Yao, Dr (13651177854, yaoyoyo19@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complete absorption rate of subretinal fluid (time frame: 3 months after the primary PDT). 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 25 May 2022.