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

NCT03758963 | Completed

• 1 other identifier: LTN-02
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

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.

Conditions

Central Serous Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Improvement of Best Corrected Visual Acuity

  3, 6 months

• Degree of Retinal Functional Damage

  3, 6 months

• Change in Sub-retinal Fluid (SRF)

  3, 6 months

• Change in Central Macular Thickness

  3, 6 months

• Removal Rate of Leakage

  6 months

Study Arms (2)

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).

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.

Device: R:GEN Selective Retina Therapy

Interventions

R:GEN Selective Retina Therapy DEVICE

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.

Active Laser; Sham Laser procedure

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LUTRONIC Corporation: lead

Study Sites (6)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Korea University Anam hospital

Seoul, South Korea

Location

Nune Eye Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

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

Seoul, South Korea

Location

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Oh Woong Kwon, PhD

  Nune Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: November 29, 2018
• Study Start: March 30, 2016
• Primary Completion: April 2, 2018
• Study Completion: June 20, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

KR (6)