Selective Retina Therapy With 'R:GEN' in Patients With Central Serous Chorioretinopathy

Central Serous Chorioretinopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03758963
• Other study ID #: LTN-02
• Status: Completed
• Phase: N/A
• Start date: March 30, 2016
• Est. completion date: June 20, 2018

Study information

• Verified date: November 2018
• Source: LUTRONIC Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 20, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Male and female adult patients aged 19 or over and less than 55

2. Patients who have had clinical symptoms of central serous chorioretinopathy over 3 months.

3. 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)

4. Patients with Sub-Retinal Fluid (SRF) that has been going into the fovea continuously

5. Patients with =1 ~ = 3 active leakage sites in Fundus Fluorescein Angiography (FA)

6. 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

7. Patients who voluntarily agree to participate in this study, and are willing to and able to follow the protocol.

Exclusion Criteria:

1. Patients with other retinal diseases such as choroidal neovascularization, polypoidal choroidal vasculopathy.

2. Patients with the conditions that make laser therapy difficult such as cataract or vitreous cloudiness.

3. Patients who have atrophy (diameter: =1000?) in the retinal pigment epithelium including the fovea.

4. Patients who had undergone laser or photodynamic therapy for central serous chorioretinopathy prior to the study participation.

5. Patients who have received steroid treatment (periocular, subtenon, intraocular) within the last one year

6. Patients who have received intraocular injection of anti-Vascular Endothelial Growth Factor (anti-VEGF) agent within the last six months.

7. Patients who have undergone ophthalmological surgery such as intraocular surgery or vitrectomy within the last six months.

8. Patients who have taken medication for central serous chorioretinopathy such as acetazolamide, spironolactone, and kalidinogenase [within the last two months].

9. Patients who have a history of allergy to fluorescein used for FA and indocyanine green used for ICG angiography.

10. Female patients who are pregnant or breastfeeding.

11. Patients with systemic diseases such as Cushing's syndrome, inflammatory diseases, uncontrolled hypertension and diabetes, liver diseases, kidney diseases.

12. Patients who have pigment epithelial detachment that is directly related to the point of leakage with a diameter of more than 1000 µm.

13. Patients who are considered ineligible for this study according to the investigator's judgment.

Related Conditions & MeSH terms

• Central Serous Chorioretinopathy

Intervention

Device:
• R:GEN Selective Retina Therapy
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Korea University Anam hospital	Seoul
Korea, Republic of	Nune Eye Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul ST.Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Yeouido St.Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
LUTRONIC Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3, 6 months
Secondary	Degree of Retinal Functional Damage	The degree of retinal functional damage is compared between study group and control group.	3, 6 months
Secondary	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.	3, 6 months
Secondary	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.	3, 6 months
Secondary	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.	6 months
Secondary	Recurrence Rate	The percentage (%) of participants who show recurrence is compared between study group and control group	6 months