This is a prospective, multicentre, sham-controlled, participant- and assessor-masked superiority trial with two parallel treatment arms which aims to investigate the safety and efficacy of subthreshold nanosecond laser (SNL) in a series of adults with sub-retinal fluid secondary to non-resolving central serous chorioretinopathy (CSCR) by visual and anatomical outcomes.
The study population will be individuals with adults (aged 18-70 years inclusive) with non-resolving CSCR (defined as CSCR present for a duration of more than 3 months presenting with either focal or diffuse leakage) who meet all eligibility criteria.
60 subjects total will be enrolled into the study - 40 randomized to receive SNL treatment and 20 to receive sham treatment as per a 2:1 randomization schedule and stratified by type of CSCR (focal vs diffuse).
The study has a 24-week study period with five scheduled visits: screening, randomisation (first treatment), 6-week follow up (with second treatment where eligible), 12-week follow-up , 18-week follow-up, and 24-week follow-up.
The primary outcome is the proportion of laser-treated study eyes that show resolution of sub-retinal fluid (SRF) as observed on optical coherence tomography (OCT) compared to sham-treated study eyes at 24 weeks.
The safety endpoint will be proportion of laser-treated eyes that lose ≥10 letters of of vision (measured on a standard vision chart) compared to sham-treated study eyes and fellow eyes over 24 weeks.
Age 18-70 years
Both males and females
Individuals with non-resolving CSCR as defined by presence of any SRF on OCT for > 3 months from date of diagnosis to randomisation visit
BCVA of 35 to 80 letters (Snellen equivalent of 6/6 to 6/60) in the study eye
A need for extraneous, continuous steroids to control any disease, including both systemic steroids (e.g., for systemic autoimmune conditions) and ocular steroids (e.g., for uveitis), or ongoing anabolic steroid use
Any systemic disease that leads to elevated endogenous steroid levels including raised 24h urinary cortisol level > 100 ug/24h consistent with Cushing's syndrome
Age related macular degeneration
Any evidence of a neovascular membrane in the macular (either exudative or non-exudative)
Parallel
2RT subthreshold nanosecond laser - active
DeviceThe 2RT™ Q-switched YAG laser (532nm) delivering 3 nanosecond pulses; 400 um spot size, is a pulsed subthreshold nanosecond (SNL) laser, which uses low energy levels to produce limited effects that selectively target melanosomes within the pigmented retinal pigment epithelial (RPE) cells.
2RT subthreshold nanosecond laser - sham
DeviceApplication of sham laser (i.e. flashing lights which replicate the look of active laser to the participant) from the 2RT subthreshold nanosecond laser device.
Resolution of sub-retinal fluid in study eyes
The change in amount of sub-retinal fluid (SRF) as observed on optical coherence tomography (OCT) imaging in the SNL-treated compared to sham-treated study eyes over 24 weeks.
Safety Endpoint
The proportion of eyes that lose ≥10 letters of best corrected visual acuity (BCVA) in the SNL-treated compared to sham-treated study and fellow eyes over 24 weeks.
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Nova Eye Medical Pty Ltd.
Lead sponsor
Center for Eye Research Australia
Collaborator
