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

Primary Purpose

Central Serous Chorioretinopathy

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

R:GEN Selective Retina Therapy

About this trial

This is an interventional treatment trial for Central Serous Chorioretinopathy

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Seoul National University Bundang Hospital
Korea University Anam hospital
Nune Eye Hospital
Seoul National University Hospital
The Catholic University of Korea Seoul ST.Mary's Hospital
The Catholic University of Korea Yeouido St.Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Laser

Sham Laser procedure

Arm Description

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. 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. 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. Within 2 hours after therapy, perform tests for efficacy evaluation (color fundus photography and fluorescein angiography).

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. Perform subsequent procedures in the same manner as the procedure of study group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Degree of Retinal Functional Damage

The degree of retinal functional damage is compared between study group and control group.

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.

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.

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.

Recurrence Rate

The percentage (%) of participants who show recurrence is compared between study group and control group

Full Information

NCT ID

NCT03758963

First Posted

November 28, 2018

Last Updated

November 28, 2018

Sponsor

LUTRONIC Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03758963

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

March 30, 2016 (Actual)

Primary Completion Date

April 2, 2018 (Actual)

Study Completion Date

June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LUTRONIC Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Serous Chorioretinopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

In this study, double-blinding will be applied for subjects and independent efficacy evaluators. It is difficult to apply blinding to the practitioner who handles the products used for therapy because of difference in the procedure of the treatment and sham, but the information related to the medical device shall not be released to subjects and independent efficacy evaluators. For blinding of independent efficacy evaluators, an independent evaluator shall conduct efficacy evaluation tests (OCT, BCVA test, contrast sensitivity test, FA). Subjects and independent efficacy evaluators will not know which group the subjects are assigned to and whether SRT or sham procedure is used. The blinding on the test device will be maintained until the data for statistical analysis are opened.

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Laser

Arm Type

Experimental

Arm Description

Arm Title

Sham Laser procedure

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

R:GEN Selective Retina Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sub-retinal Fluid (SRF) Removal Rate

Description

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.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Improvement of Best Corrected Visual Acuity

Description

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.

Time Frame

3, 6 months

Title

Degree of Retinal Functional Damage

Description

The degree of retinal functional damage is compared between study group and control group.

Time Frame

3, 6 months

Title

Change in Sub-retinal Fluid (SRF)

Description

The change in Sub-retinal Fluid (SRF) (μm, mm3) on Optical Coherence Tomography (OCT) is compared between study group and control group.

Time Frame

3, 6 months

Title

Change in Central Macular Thickness

Description

The change on Central Macular Thickness (CMT) (μm) based on Optical Coherence Tomography (OCT) results are compared between the study and control group.

Time Frame

3, 6 months

Title

Removal Rate of Leakage

Description

The percentage (%) of participants who show complete removal of leakage in Fluorescene Angiography (FA) results is compared between study group and control group.

Time Frame

6 months

Title

Recurrence Rate

Description

The percentage (%) of participants who show recurrence is compared between study group and control group

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oh Woong Kwon, PhD

Organizational Affiliation

Nune Eye Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

Country

Korea, Republic of

Facility Name

Korea University Anam hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Nune Eye Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

The Catholic University of Korea Seoul ST.Mary's Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

The Catholic University of Korea Yeouido St.Mary's Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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