Clinical trial NCT03758963: 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
Overall status: COMPLETED
Phase: NA
Conditions: Central Serous Chorioretinopathy
Lead sponsor: LUTRONIC Corporation
Sponsor class: INDUSTRY
First posted: 2018-11-29
Enrollment: 63
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sub-retinal Fluid (SRF) Removal Rate
timeFrame: 3 months
Secondary outcomes:
measure: Improvement of Best Corrected Visual Acuity
timeFrame: 3, 6 months
measure: Degree of Retinal Functional Damage
timeFrame: 3, 6 months
measure: Change in Sub-retinal Fluid (SRF)
timeFrame: 3, 6 months
measure: Change in Central Macular Thickness
timeFrame: 3, 6 months
measure: Removal Rate of Leakage
timeFrame: 6 months
measure: Recurrence Rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam hospital
city: Seoul
country: Korea, Republic of
facility: Nune Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul ST.Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Yeouido St.Mary's Hospital
Study officials:
affiliation: Nune Eye Hospital
name: Oh Woong Kwon, PhD
role: PRINCIPAL_INVESTIGATOR
References: