Central Serous ChorioretinopathyNCT03758963
Selective Retina Therapy With 'R:GEN' in Patients With Central Serous Chorioretinopathy
A study testing R:GEN Selective Retina Therapy in people with Central Serous Chorioretinopathy, run by CynosureLutronic at 6 sites in South Korea.
Trial summary
The purpose of this clinical study is to evaluate the efficacy and safety of selective retina therapy (SRT) using R:GEN, an approved laser device, in patients with central serous chorioretinopathy. Read more about this study
- Who is it for?
- Ages 19 to 55 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- R:GEN Selective Retina Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 30 Mar 2016to 20 Jun 2018
- 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 19 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female adult patients aged 19 or over and less than 55
- Patients who have had clinical symptoms of central serous chorioretinopathy over 3 months.
- Patients whose best corrected visual acuity (BCVA) is at least 20/200 based on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart (BCVA based on the ETDRS chart will be converted into logMAR)
- Patients with Sub-Retinal Fluid (SRF) that has been going into the fovea continuously
- Patients with ≥1 ~ ≤ 3 active leakage sites in Fundus Fluorescein Angiography (FA)
- Patients who are of child-bearing potential and have agreed to use a medically acceptable contraceptive method during the study period
- ☞Medically acceptable contraceptive method: Condom, oral contraceptive pills that have been continued for more than three months, contraceptive injection or implants or intrauterine contraceptive device
- Patients who voluntarily agree to participate in this study, and are willing to and able to follow the protocol.
Who cannot join
- Patients with other retinal diseases such as choroidal neovascularization, polypoidal choroidal vasculopathy.
- Patients with the conditions that make laser therapy difficult such as cataract or vitreous cloudiness.
- Patients who have atrophy (diameter: ≥1000㎛) in the retinal pigment epithelium including the fovea.
- Patients who had undergone laser or photodynamic therapy for central serous chorioretinopathy prior to the study participation.
- Patients who have received steroid treatment (periocular, subtenon, intraocular) within the last one year
- Patients who have received intraocular injection of anti-Vascular Endothelial Growth Factor (anti-VEGF) agent within the last six months.
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- Patients who have undergone ophthalmological surgery such as intraocular surgery or vitrectomy within the last six months.
- Patients who have taken medication for central serous chorioretinopathy such as acetazolamide, spironolactone, and kalidinogenase [within the last two months].
- Patients who have a history of allergy to fluorescein used for FA and indocyanine green used for ICG angiography.
- Female patients who are pregnant or breastfeeding.
- Patients with systemic diseases such as Cushing's syndrome, inflammatory diseases, uncontrolled hypertension and diabetes, liver diseases, kidney diseases.
- Patients who have pigment epithelial detachment that is directly related to the point of leakage with a diameter of more than 1000 μm.
- Patients who are considered ineligible for this study according to the investigator's judgment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Seoul National University Bundang Hospital
Seongnam-si
Korea University Anam hospital
Seoul
Nune Eye Hospital
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea Seoul ST.Mary's Hospital
Seoul
The Catholic University of Korea Yeouido St.Mary's Hospital
Seoul
About this study
Official title: A Prospective, Multi-center, Randomized, Double-blinded (Subject & Independent Efficacy Evaluator), Comparative Clinical Study to Evaluate the Efficacy and Safety of SRT (Selective Retina Therapy) With 'R:GEN' in Patients With Central Serous Chorioretinopathy
The purpose of this clinical study is to evaluate the efficacy and safety of selective retina therapy (SRT) using R:GEN, an approved laser device, in patients with central serous chorioretinopathy.
Read the detailed description
In this study, treatment effect of each group will be evaluated by follow-up once a month of both study group and control group other than the 2nd month until 6 months following the first procedure.
For the primary efficacy evaluation, the percentage of subjects who show complete removal of sub-retinal fluid (SRF) in Optical Coherence Tomography (OCT) results will be evaluated in the study group, before SRF therapy and at 3 months after therapy, and in control group, before sham procedure using R:GEN and at 3 months after therapy. In addition, for secondary efficacy evaluation, major symptoms of central serous chorioretinopathy will be evaluated at 3 and 6 months including changes in best corrected visual acuity (BCVA) on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, the degree of retinal functional damage, and changes in sub-retinal fluid (SRF) and central macula thickness (CMT) on OCT. At 6 months, removal rate of leakage on Fluorescene Angiography (FA) and recurrence of the disease will be evaluated to compare the recurrence rate of study group and control group undergoing sham procedure.
The subjects in the study group who only meet the conditions of retreatment at 3 ~ 5 months after selective retina therapy (SRT) may receive SRT up to twice again.
The subjects in the control group those who have not recovered naturally but have persistent clinical symptoms at 3 months will undergo SRT. And the subjects in the control group who only meet the conditions of retreatment at 5 months after SRT at 2 months.
And the subjects in the control group, who have experienced complete disappearance of SRF at 3 months after Sham procedure, but SRF is observed again at 4 or 5 months, may receive SRT up to twice again.
These subjects will be categorized into a separate subgroup and the efficacy and safety of SRT will be evaluated every visit.
- Conditions
- Central Serous Chorioretinopathy
- Being tested
- R:GEN Selective Retina 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.
R:GEN Selective Retina TherapyDevice
Selective Retina Therapy (SRT) is the treatment method using innovative laser technology with the wavelength absorbed by melanosomes such as laser photocoagulation, but due to short pulse width (1.7 µs) with 100 Hz repetition rate, Retinal Pigment Epithelium (RPE) cells may be destroyed only through the generation of microbubble around melanosomes (photomechanical action), and no thermal damage of normal cells or tissues may occur in the surrounding tissues. SRT influences the RPE wound healing, including migration and proliferation of RPE cells, which treats CSC in the mechanism of recovering RPE. Once RPE is recovered, the sub-retinal fluid may be pumped out and retinal function again recovered. Moreover, previous studies showed that SRT may stimulate a moderate increase of activated metalloproteinase (MMP), leading to the improvement of Bruch's membrane's transport property.
| Study group | Role | What they receive |
|---|---|---|
| Active Laser | Experimental | 1. Once the energy to be applied for the treatment is determined through the laser irradiation testing, conduct laser therapy after selecting "T" corresponding to treatment laser on GUI.
2. At irradiation, excluding the circle area with a 100 μm radius (200 μm diameter) from the center of the fovea, irradiate laser in the form of surrounding the leakage site with an interval of 0.5-1 spot diameter (fovea = 1 spot size). As for the test spots, the serial number needs to be given for each treatment spot with the order of irradiation, as described above.
3. If pigment epithelial detachment (PED) occurs at the leakage site, irradiate laser around the PED (excluding the circle area with a 100 μm radius (200 μm diameter) from the center), not to the leakage site.
4. Within 2 hours after therapy, perform tests for efficacy evaluation (color fundus photography and fluorescein angiography). Receives: Device: R:GEN Selective Retina Therapy |
| Sham Laser procedure | Sham comparator | 1. Select "C" corresponding to Sham Therapy on GUI of the laser device, and then perform Sham therapy.
* During Sham therapy, for patient's blinding, both light from the slit lamp and sound from laser oscillation are same as laser irradiation, and no laser oscillation will occur for treatment.
2. Perform subsequent procedures in the same manner as the procedure of study group. Receives: Device: R:GEN Selective Retina Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-retinal Fluid (SRF) Removal Rate
The percentage of subjects (%) who show complete removal of Sub-retinal Fluid (SRF) on Optical Coherence Tomography (OCT) is compared between study group and control group.
Measured: 3 months
Secondary outcomes (6)
Improvement of Best Corrected Visual Acuity
The improvement of Best Corrected Visual Acuity is evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart and is compared between study group and control group.
Measured: 3, 6 months
Degree of Retinal Functional Damage
The degree of retinal functional damage is compared between study group and control group.
Measured: 3, 6 months
Change in Sub-retinal Fluid (SRF)
The change in Sub-retinal Fluid (SRF) (μm, mm3) on Optical Coherence Tomography (OCT) is compared between study group and control group.
Measured: 3, 6 months
Change in Central Macular Thickness
The change on Central Macular Thickness (CMT) (μm) based on Optical Coherence Tomography (OCT) results are compared between the study and control group.
Measured: 3, 6 months
Removal Rate of Leakage
The percentage (%) of participants who show complete removal of leakage in Fluorescene Angiography (FA) results is compared between study group and control group.
Measured: 6 months
Recurrence Rate
The percentage (%) of participants who show recurrence is compared between study group and control group
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 posted29 Nov 2018
- Study start30 Mar 2016
- Primary completion2 Apr 2018
- Study completion20 Jun 2018
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.
- 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- CynosureLutronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oh Woong Kwon, PhD, Principal investigator, Nune Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758963
- Sponsor's protocol ID
- LTN-02
- Status last verified
- Nov 2018
- First submitted
- 28 Nov 2018
- Last updated
- 29 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Double-blinded (Subject & Independent Efficacy Evaluator), Comparative Clinical Study to Evaluate the Efficacy and Safety of SRT (Selective Retina Therapy) With 'R:GEN' in Patients With Central Serous Chorioretinopathy
- ClinicalTrials.gov ID
- NCT03758963
- Acronym / sponsor ID
- LTN-02
- Conditions
- Central Serous Chorioretinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- CynosureLutronicIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 29 Nov 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.
The purpose of this clinical study is to evaluate the efficacy and safety of selective retina therapy (SRT) using R:GEN, an approved laser device, in patients with central serous chorioretinopathy.
Detailed description
In this study, treatment effect of each group will be evaluated by follow-up once a month of both study group and control group other than the 2nd month until 6 months following the first procedure.
For the primary efficacy evaluation, the percentage of subjects who show complete removal of sub-retinal fluid (SRF) in Optical Coherence Tomography (OCT) results will be evaluated in the study group, before SRF therapy and at 3 months after therapy, and in control group, before sham procedure using R:GEN and at 3 months after therapy. In addition, for secondary efficacy evaluation, major symptoms of central serous chorioretinopathy will be evaluated at 3 and 6 months including changes in best corrected visual acuity (BCVA) on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, the degree of retinal functional damage, and changes in sub-retinal fluid (SRF) and central macula thickness (CMT) on OCT. At 6 months, removal rate of leakage on Fluorescene Angiography (FA) and recurrence of the disease will be evaluated to compare the recurrence rate of study group and control group undergoing sham procedure.
The subjects in the study group who only meet the conditions of retreatment at 3 ~ 5 months after selective retina therapy (SRT) may receive SRT up to twice again.
The subjects in the control group those who have not recovered naturally but have persistent clinical symptoms at 3 months will undergo SRT. And the subjects in the control group who only meet the conditions of retreatment at 5 months after SRT at 2 months.
And the subjects in the control group, who have experienced complete disappearance of SRF at 3 months after Sham procedure, but SRF is observed again at 4 or 5 months, may receive SRT up to twice again.
These subjects will be categorized into a separate subgroup and the efficacy and safety of SRT will be evaluated every visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Laser | Experimental | Device: R:GEN Selective Retina Therapy1. Once the energy to be applied for the treatment is determined through the laser irradiation testing, conduct laser therapy after selecting "T" corresponding to treatment laser on GUI. 2. At irradiation, excluding the circle area with a 100 μm radius (200 μm diameter) from the center of the fovea, irradiate laser in the form of surrounding the leakage site with an interval of 0.5-1 spot diameter (fovea = 1 spot size). As for the test spots, the serial number needs to be given for each treatment spot with the order of irradiation, as described above. 3. If pigment epithelial detachment (PED) occurs at the leakage site, irradiate laser around the PED (excluding the circle area with a 100 μm radius (200 μm diameter) from the center), not to the leakage site. 4. Within 2 hours after therapy, perform tests for efficacy evaluation (color fundus photography and fluorescein angiography). |
| Sham Laser procedure | Sham comparator | Device: R:GEN Selective Retina Therapy1. Select "C" corresponding to Sham Therapy on GUI of the laser device, and then perform Sham therapy. * During Sham therapy, for patient's blinding, both light from the slit lamp and sound from laser oscillation are same as laser irradiation, and no laser oscillation will occur for treatment. 2. Perform subsequent procedures in the same manner as the procedure of study group. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male and female adult patients aged 19 or over and less than 55
- Patients who have had clinical symptoms of central serous chorioretinopathy over 3 months.
- Patients whose best corrected visual acuity (BCVA) is at least 20/200 based on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart (BCVA based on the ETDRS chart will be converted into logMAR)
- Patients with Sub-Retinal Fluid (SRF) that has been going into the fovea continuously
- Patients with ≥1 ~ ≤ 3 active leakage sites in Fundus Fluorescein Angiography (FA)
Key exclusion criteria (13 listed)
- Patients with other retinal diseases such as choroidal neovascularization, polypoidal choroidal vasculopathy.
- Patients with the conditions that make laser therapy difficult such as cataract or vitreous cloudiness.
- Patients who have atrophy (diameter: ≥1000㎛) in the retinal pigment epithelium including the fovea.
- Patients who had undergone laser or photodynamic therapy for central serous chorioretinopathy prior to the study participation.
- Patients who have received steroid treatment (periocular, subtenon, intraocular) within the last one year
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 |
|---|---|---|
| R:GEN Selective Retina TherapySelective Retina Therapy (SRT) is the treatment method using innovative laser technology with the wavelength absorbed by melanosomes such as laser photocoagulation, but due to short pulse width (1.7 µs) with 100 Hz repetition rate, Retinal Pigment Epithelium (RPE) cells may be destroyed only through the generation of microbubble around melanosomes (photomechanical action), and no thermal damage of normal cells or tissues may occur in the surrounding tissues. SRT influences the RPE wound healing, including migration and proliferation of RPE cells, which treats CSC in the mechanism of recovering RPE. Once RPE is recovered, the sub-retinal fluid may be pumped out and retinal function again recovered. Moreover, previous studies showed that SRT may stimulate a moderate increase of activated metalloproteinase (MMP), leading to the improvement of Bruch's membrane's transport property. | Device | Active Laser, Sham Laser procedure |
Primary outcome
Sub-retinal Fluid (SRF) Removal Rate
Time frame: 3 months
The percentage of subjects (%) who show complete removal of Sub-retinal Fluid (SRF) on Optical Coherence Tomography (OCT) is compared between study group and control group.
6 secondary outcomes
Improvement of Best Corrected Visual Acuity
Time frame: 3, 6 months
Degree of Retinal Functional Damage
Time frame: 3, 6 months
Change in Sub-retinal Fluid (SRF)
Time frame: 3, 6 months
Change in Central Macular Thickness
Time frame: 3, 6 months
Removal Rate of Leakage
Time frame: 6 months
Recurrence Rate
Time frame: 6 months
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 29 Nov 2018.
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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.
Oh Woong Kwon, PhD principal investigator
Nune Eye Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing R:GEN Selective Retina Therapy in people with Central Serous Chorioretinopathy, run by CynosureLutronic at 6 sites 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 8 inclusion and 13 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 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. 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?
Sub-retinal Fluid (SRF) Removal Rate (time frame: 3 months). 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 29 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.