Acute Central Serous ChorioretinopathyNCT02587767
577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy
A study testing 577-MPL and HD-PDT in people with Acute Central Serous Chorioretinopathy, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to determine whether micropulse laser (MPL) is different to half-dose photodynamic therapy on acute central serous chorioretinopathy. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Central Serous Chorioretinopathy
- What is being tested?
- 577-MPL and HD-PDT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2019
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- onset for the first time, as an episode duration of less than 6 months
- patient was between 18 and 55 years of age
- the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)
- active fluorescein leakage during fluorescein angiography (FA)
- best corrected visual acuity (BCVA) more than 0.1, and less than 1.0
Who cannot join
- previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery
- other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)
- retinal atrophy
- pregnancy
- inability to obtain photographs or to perform FA
- use of steroid systemically or topically in the last 6 months
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Prospective Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy
The purpose of this study is to determine whether micropulse laser (MPL) is different to half-dose photodynamic therapy on acute central serous chorioretinopathy.
Read the detailed description
Central serous chorioretinopathy(CSC) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity.Some studies have shown that Half-dose photodynamic therapy(PDT) is effective on CSC,although accompanied with side-effects,such as choroidal ischemia, retinal pigmental epithelium(RPE) atrophy,and RPE rip,and with exorbitant price.Recent retrospective studies suggest micropulse laser (MPL) therapy may also be effective without obvious complications in this disease. But to date, there is no study on effectiveness of CSC between PDT and MPL.
The study is the first prospective randomized controlled trial about 577nm micropulse laser versus half-dose photodynamic therapy on acute central serous chorioretinopathy.The null hypothesis of the study is that there is difference between MPL and half-dose photodynamic therapy on acute central serous chorioretinopathy at first month after treatment.The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid at 1 month after treatment.
- Conditions
- Acute Central Serous Chorioretinopathy
- Being tested
- 577-MPL, HD-PDT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
577-MPLDevice
All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle.
HD-PDTDevice
5 minutes after the start of the half-dose verteporfin infusion, the PDT treatment will been performed in HD-PDT arm. The treatment is performed with standard fluency (50 J/cm2), a PDT laser wavelength of 689 nm, and a standard treatment duration of 83 seconds.
| Study group | Role | What they receive |
|---|---|---|
| 577-MPL | Experimental | 577nm micropulse laser(577-MPL) will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Multiple laser spots will be applied, covering the leakage area. Receives: Device: 577-MPL |
| HD-PDT | Active comparator | Half-dose photodynamic therapy (HD-PDT) is administered to the patients. At 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689nm, and a treatment duration of 83 seconds. Receives: Device: HD-PDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of eyes with complete absorption of subretinal fluid(SRF)
The primary outcome 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
Secondary outcomes (4)
Change of Best Corrected Visual Acuity(BCVA)
Measured: 1 month, 3 month, 6 month
Change of fundus autofluorescence
Fundus autofluorescence will be evaluated for different patterns（normal, increased, and decreased）before and after treatment
Measured: 1 month, 3 month, 6 month
Change in 10°retinal sensitivity
Retinal sensitivity will be measured by microperimetry
Measured: 1 month, 3 month, 6 month
the proportion of eyes with complete absorption of subretinal fluid(SRF)
The outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startSep 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Chen-jin, Sun Yat-sen University
- Investigators
- Chenjin Jin, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityLijun Zhou, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587767
- Sponsor's protocol ID
- 577MPLACS(Marshall Study)
- Status last verified
- Apr 2022
- First submitted
- 17 Oct 2015
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: it is undecided to make individual participant data available when the study is going on
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Clinical Trial to Evaluate the Effects of 577nm Micropulse Laser vs Half-dose Photodynamic Therapy on Acute Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT02587767
- Acronym / sponsor ID
- 577MPLACS(Marshall Study)
- Conditions
- Acute Central Serous Chorioretinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 27 Oct 2015 (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 whether micropulse laser (MPL) is different to half-dose photodynamic therapy on acute central serous chorioretinopathy.
Detailed description
Central serous chorioretinopathy(CSC) is characterized by serous detachment of neurosensory retina which can cause lose in visual acuity.Some studies have shown that Half-dose photodynamic therapy(PDT) is effective on CSC,although accompanied with side-effects,such as choroidal ischemia, retinal pigmental epithelium(RPE) atrophy,and RPE rip,and with exorbitant price.Recent retrospective studies suggest micropulse laser (MPL) therapy may also be effective without obvious complications in this disease. But to date, there is no study on effectiveness of CSC between PDT and MPL.
The study is the first prospective randomized controlled trial about 577nm micropulse laser versus half-dose photodynamic therapy on acute central serous chorioretinopathy.The null hypothesis of the study is that there is difference between MPL and half-dose photodynamic therapy on acute central serous chorioretinopathy at first month after treatment.The primary outcome measures is the proportion of eyes with complete absorption of subretinal fluid at 1 month after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 577-MPL | Experimental | Device: 577-MPL577nm micropulse laser(577-MPL) will be performed of the areas identified on hyperfluorescent "hot spots" on the mid-phase (3 minutes) fluorescein.Multiple laser spots will be applied, covering the leakage area. |
| HD-PDT | Active comparator | Device: HD-PDTHalf-dose photodynamic therapy (HD-PDT) is administered to the patients. At 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689nm, and a treatment duration of 83 seconds. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- onset for the first time, as an episode duration of less than 6 months
- patient was between 18 and 55 years of age
- the presence of subretinal fluid(SRF) involving the macula and detected by use of optical coherence tomography (OCT)
- active fluorescein leakage during fluorescein angiography (FA)
- best corrected visual acuity (BCVA) more than 0.1, and less than 1.0
Key exclusion criteria (6 listed)
- previous PDT, focal photocoagulation, intravitreal injections of anti-vascular endothelial growth factor, or ocular surgery
- other macular abnormalities such as choroidal neovascularization(CNV) or polypoidal choroidal vasculopathy(PCV)
- retinal atrophy
- pregnancy
- inability to obtain photographs or to perform FA
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 |
|---|---|---|
| 577-MPLAll treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle. | Device | 577-MPL |
| HD-PDT5 minutes after the start of the half-dose verteporfin infusion, the PDT treatment will been performed in HD-PDT arm. The treatment is performed with standard fluency (50 J/cm2), a PDT laser wavelength of 689 nm, and a standard treatment duration of 83 seconds. | Device | HD-PDT |
Primary outcome
the proportion of eyes with complete absorption of subretinal fluid(SRF)
Time frame: 1 month
The primary outcome measure is the OCT-based improvement rate (defined as the proportion of eyes with complete absorption of subretinal fluid on OCT images
4 secondary outcomes
Change of Best Corrected Visual Acuity(BCVA)
Time frame: 1 month, 3 month, 6 month
Change of fundus autofluorescence
Time frame: 1 month, 3 month, 6 month
Change in 10°retinal sensitivity
Time frame: 1 month, 3 month, 6 month
the proportion of eyes with complete absorption of subretinal fluid(SRF)
Time frame: 6 month
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 5 Apr 2022.
- Individual participant dataSharing planned: Undecided. it is undecided to make individual participant data available when the study is going on
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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
Lijun Zhou principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 577-MPL and HD-PDT in people with Acute Central Serous Chorioretinopathy, run by Sun Yat-sen University 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 5 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 5 Apr 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?
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?
the proportion of eyes with complete absorption of subretinal fluid(SRF) (time frame: 1 month). 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 5 Apr 2022.