NCT03758963

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: CynosureLutronic · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Central Serous Chorioretinopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-03-30
• Primary completion: 2018-04-02
• Completion: 2018-06-20
• First posted: 2018-11-29
• Last updated: 2018-11-29

Locations

6 sites across 1 country: South Korea