Central Serous ChorioretinopathyNCT03692169
The Changes of Retinal Capillaries After Half-dose PDT Measured by OCTA in Eyes With CSC
An observational study of Central Serous Chorioretinopathy, run by Jin Chen-jin at 2 sites in China.
Trial summary
To determine changes in retinal and choroidal capillaries with optical coherence tomographic angiography (OCTA) after half-dose photodynamic therapy (hd-PDT) in eyes with central serous chorioretinopathy (CSC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- Half-dose photodynamic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 31 Oct 2016to 30 Jun 2019
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Patients with Central Serous Chorioretinopathy (CSC)
Who may be able to join
- CSC diagnosed by FFA and ICGA, where the active leakage was just located in macular fovea with SRF confirmed by OCT
- Patient age ≥18 years
- BCVA ≥35 letters on ETDRS charts
- Persistent CSC for a period of time or patients were anxiety about the symptom and asking for treatment
- Lack of either spontaneous improvement or improvement induced by empirical treatment such as pharmaceutical drug
- The provision of written informed consent -
Who cannot join
- The presence of any other chorioretinal diseases that may affect the studies, such as age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV)
- Patients who had received any previous treatment, including PDT, intraocular drug injection or focal thermal laser photocoagulation for CSC
- Patients with PED in macular fovea which the average diameter (transverse diameter and vertical diameter) was more than 300 microns
- Patients with high myopia, defined as a refractive error (spherical equivalent) < -6.00 diopters, or an axial length >26.5 mm
- Patients with media opacities, or signal strength index of the images < 60
- Patients under corticosteroid therapy -
Trial locations and contacts
2 sites in 1 country.
China2 sites, 1 recruiting
- Completed
Fabao Xu
Guangzhou, Guangdong, 510000
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: The Changes of Retinal and Choroidal Capillaries After Half-dose Photodynamic Therapy Measured by Angio- OCT in Eyes With Central Serous Chorioretinopathy
To determine changes in retinal and choroidal capillaries with optical coherence tomographic angiography (OCTA) after half-dose photodynamic therapy (hd-PDT) in eyes with central serous chorioretinopathy (CSC).
Read the detailed description
PDT was hypothesized to have a primary effect on the choroidal capillaries, and a number of studies have reported choriocapillary damage and choroidal vascular remodeling after PDT. More recently, although OCTA related CSC research has been conducted, no quantitative report has thoroughly investigated the microstructural changes in the superficial, deep retinal and choroidal capillaries after hd-PDT. The purpose of the present study is to determine the changes in the retinal and choroidal capillaries quantitatively with OCTA after hd-PDT in eyes with CSC.
This is a prospective observational study of patients undergoing hd-PDT for CSC with active leakage in retinal pigment epithelium (RPE) and followed for 3 months. Fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA) were performed at baseline; best corrected visual acuity (BCVA), fundus photography, optical coherence tomography angiography (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up visit after hd-PDT.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- Half-dose photodynamic therapy
- Keywords
- Central serous chorioretinopathy
- 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.
Half-dose photodynamic therapyProcedure or surgery
Half-dose photodynamic therapy was achieved by administering 3mg/m² of Verteporfin (Visudyne; Novartis, Switzerland) intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the greatest linear dimension was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². Optical coherence tomography angiography (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up (one month and three months) visit after hd-PDT.
| Study group | Role | What they receive |
|---|---|---|
| CSC patients | Half-dose photodynamic therapy was performed when a serous retinal detachment involving the macular fovea was present; The treatment field size was set as 3000 microns. This was achieved by administering 3mg/m² of Verteporfin intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the GLD was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². OCTA (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up (one month and three months) visit after hd-PDT. Receives: Procedure: Half-dose photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of retinal capillaries after hd-PDT
The primary outcome measure is the OCTA-based changes in the retinal capillaries after hd-PDT
Measured: 1 month, 3 month
Secondary outcomes (3)
The proportion of eyes with complete absorption of subretinal fluid(SRF)
The outcome 2 measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images)
Measured: 1 month, 3 month
Change of Best Corrected Visual Acuity(BCVA)
The outcome 3 measure is the EDTRS charts-based improvement of Best Corrected Visual Acuity
Measured: 1 month, 3 month
Changes of choroidal thickness after hd-PDT
The outcome 4 measure is the OCT-based thinning of choroidal thickness after hd-PDT
Measured: 1 month, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start31 Oct 2016
- Primary completion10 Oct 2018 (estimated)
- Study completion30 Jun 2019 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Chen-jin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Chen-jin, Sun Yat-sen University
- Investigators
- Chenjin Jin, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692169
- Sponsor's protocol ID
- CSC-PDT-OCTA（ZOC）
- Status last verified
- Sep 2018
- First submitted
- 26 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Peng J, Zhong L, Ma L, Jin J, Zheng Y, Jin C. Comparison of vascular parameters between normal cynomolgus macaques and healthy humans by optical coherence tomography angiography. BMC Ophthalmol. 2019 Oct 11;19(1):204. doi: 10.1186/s12886-019-1207-x.
PubMed 31601186
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes of Retinal and Choroidal Capillaries After Half-dose Photodynamic Therapy Measured by Angio- OCT in Eyes With Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT03692169
- Acronym / sponsor ID
- CSC-PDT-OCTA（ZOC）
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- Central serous chorioretinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jin Chen-jinUniversity, hospital or other
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 10 Oct 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 2 Oct 2018 (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.
To determine changes in retinal and choroidal capillaries with optical coherence tomographic angiography (OCTA) after half-dose photodynamic therapy (hd-PDT) in eyes with central serous chorioretinopathy (CSC).
Detailed description
PDT was hypothesized to have a primary effect on the choroidal capillaries, and a number of studies have reported choriocapillary damage and choroidal vascular remodeling after PDT. More recently, although OCTA related CSC research has been conducted, no quantitative report has thoroughly investigated the microstructural changes in the superficial, deep retinal and choroidal capillaries after hd-PDT. The purpose of the present study is to determine the changes in the retinal and choroidal capillaries quantitatively with OCTA after hd-PDT in eyes with CSC.
This is a prospective observational study of patients undergoing hd-PDT for CSC with active leakage in retinal pigment epithelium (RPE) and followed for 3 months. Fundus fluorescein angiography (FFA) and indocyanine green angiography (ICGA) were performed at baseline; best corrected visual acuity (BCVA), fundus photography, optical coherence tomography angiography (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up visit after hd-PDT.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSC patients | – | Procedure: Half-dose photodynamic therapyHalf-dose photodynamic therapy was performed when a serous retinal detachment involving the macular fovea was present; The treatment field size was set as 3000 microns. This was achieved by administering 3mg/m² of Verteporfin intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the GLD was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². OCTA (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up (one month and three months) visit after hd-PDT. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Central Serous Chorioretinopathy (CSC)
Key inclusion criteria (6 listed)
- CSC diagnosed by FFA and ICGA, where the active leakage was just located in macular fovea with SRF confirmed by OCT
- Patient age ≥18 years
- BCVA ≥35 letters on ETDRS charts
- Persistent CSC for a period of time or patients were anxiety about the symptom and asking for treatment
- Lack of either spontaneous improvement or improvement induced by empirical treatment such as pharmaceutical drug
Key exclusion criteria (6 listed)
- The presence of any other chorioretinal diseases that may affect the studies, such as age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV)
- Patients who had received any previous treatment, including PDT, intraocular drug injection or focal thermal laser photocoagulation for CSC
- Patients with PED in macular fovea which the average diameter (transverse diameter and vertical diameter) was more than 300 microns
- Patients with high myopia, defined as a refractive error (spherical equivalent) < -6.00 diopters, or an axial length >26.5 mm
- Patients with media opacities, or signal strength index of the images < 60
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 |
|---|---|---|
| Half-dose photodynamic therapyHalf-dose photodynamic therapy was achieved by administering 3mg/m² of Verteporfin (Visudyne; Novartis, Switzerland) intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the greatest linear dimension was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². Optical coherence tomography angiography (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up (one month and three months) visit after hd-PDT. | Procedure or surgery | CSC patients |
Primary outcome
Changes of retinal capillaries after hd-PDT
Time frame: 1 month, 3 month
The primary outcome measure is the OCTA-based changes in the retinal capillaries after hd-PDT
3 secondary outcomes
The proportion of eyes with complete absorption of subretinal fluid(SRF)
Time frame: 1 month, 3 month
Change of Best Corrected Visual Acuity(BCVA)
Time frame: 1 month, 3 month
Changes of choroidal thickness after hd-PDT
Time frame: 1 month, 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Derived from this study: PubMed 31601186Peng J, Zhong L, Ma L, Jin J, Zheng Y, Jin C. Comparison of vascular parameters between normal cynomolgus macaques and healthy humans by optical coherence tomography angiography. BMC Ophthalmol. 2019 Oct 11;19(1):204. doi: 10.1186/s12886-019-1207-x.
- Individual participant dataSharing planned: Undecided
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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.
Chenjin Jin study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
2 sites 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 Jin Chen-jin at 2 sites 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 6 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: status not confirmed, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Fabao Xu (15521250400, 517311823@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of retinal capillaries after hd-PDT (time frame: 1 month, 3 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 NCT03692169, 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 2 Oct 2018.