Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy

NCT05570591 | Recruiting

• 1 other identifier: NANO-C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Central Serous Chorioretinopathy

Keywords

Subthreshold nanosecond laser; Laser; 2RT; CSR; Central Serous Chorioretinopathy; Chorioretinopathy

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Other Outcomes (1)

• Safety Endpoint

  24 weeks

Study Arms (2)

Active laser

ACTIVE COMPARATOR

Application of the active 2RT sub threshold laser

Device: 2RT subthreshold nanosecond laser - active

Sham laser

SHAM COMPARATOR

Application of sham laser (i.e. flashing lights which replicate the look of active laser to the participant)

Device: 2RT subthreshold nanosecond laser - sham

Interventions

2RT subthreshold nanosecond laser - active DEVICE

The 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.

Also known as: 2RT, SNL

Active laser

2RT subthreshold nanosecond laser - sham DEVICE

Application of sham laser (i.e. flashing lights which replicate the look of active laser to the participant) from the 2RT subthreshold nanosecond laser device.

Also known as: Sham laser

Sham laser

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ability, willingness and sufficient cognitive awareness to consent to the trial, received randomised SNL treatment or sham procedure, and complete all visits as per the study schedule

You may not qualify if:

• 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
• Any ocular disease in the study eye, other than CSCR, which in the opinion of the investigator may significantly compromise assessment of the retina, or which would compromise the ability to assess any effect following SNL treatment including, but not limited to:
• Age related macular degeneration
• Any evidence of a neovascular membrane in the macular (either exudative or non-exudative)
• Diabetic retinopathy (unless limited to fewer than 10 microaneurysms and/or small retinal haemorrhages, without retinal thickening on OCT)
• Macular pathology or pigmentary abnormalities including but not limited to: pattern dystrophy, myopic maculopathy, angioid streaks, resumed ocular histoplasmosis syndrome, visually-significant epiretinal membranes, macular hole or pseudohole
• Optic nerve pathology, including optic atrophy, history of optic neuropathy
• Myopic crescent wider than 50% of the longest diameter of the optic disc, or closer than 1500 µm to the fovea
• Retinal vascular diseases including branch or central vein or artery occlusion
• Choroidal nevus within 2 DD of the fovea associated with depigmentation or overlying drusen, if these drusen are used to determine eligibility
• Active uveitis or ocular inflammation
• Corneal pathology precluding visualization of fundus or increasing the risk of using a contact lens, such as corneal dystrophy, recurrent corneal erosion syndrome or sensitivity to the application of a contact lens
• History or presence of uncontrolled glaucoma or raised intraocular pressure which would preclude safe dilation of the pupil to allow adequate assessment and application of SNL treatment
• History of prior laser surgery to the retina including subthreshold laser (focal retinopexy for a peripheral retinal tear performed more than 90 days prior to the entry into the study is permitted)

Sponsors & Collaborators

• Nova Eye Medical Pty Ltd.: lead
• Center for Eye Research Australia: collaborator

Study Sites (2)

Centre for Eye Research Australia

East Melbourne, Victoria, 3002, Australia

RECRUITING

Retinology Institute

Glen Iris, Victoria, 3146, Australia

RECRUITING

MeSH Terms

Conditions

Central Serous Chorioretinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Mali Okada, MBBS FRANZCO

  Center for Eye Research Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Spurling

CONTACT

+61 8 8362 0193; tspurling@nova-eye.com

Chris Baker

CONTACT

+61 8 8362 0193; cbaker@nova-eye.com

Study Design

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

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: October 18, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)