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

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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

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.
    


Study Type

Interventional


Primary Outcome

Sub-retinal Fluid (SRF) Removal Rate

Secondary Outcome

 Improvement of Best Corrected Visual Acuity

Condition

Central Serous Chorioretinopathy

Intervention

R:GEN Selective Retina Therapy

Study Arms / Comparison Groups

 Active Laser
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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

63

Start Date

March 30, 2016

Completion Date

June 20, 2018

Primary Completion Date

April 2, 2018

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.
      

Gender

All

Ages

19 Years - 55 Years

Accepts Healthy Volunteers

No

Contacts

Oh Woong Kwon, PhD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT03758963

Organization ID

LTN-02


Responsible Party

Sponsor

Study Sponsor

LUTRONIC Corporation


Study Sponsor

Oh Woong Kwon, PhD, Principal Investigator, Nune Eye Hospital


Verification Date

November 2018