Central Serous ChorioretinopathyNANO-CNCT05570591
Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy
A study testing 2RT subthreshold nanosecond laser - active in people with Central Serous Chorioretinopathy, run by Nova Eye Medical Pty Ltd. at 2 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Central Serous Chorioretinopathy
- What is being tested?
- 2RT subthreshold nanosecond laser - active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesAustralia
- Study dates
- 18 Oct 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 23Show fewer
- 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)
- Significant cataract or other ocular media which, in the opinion of the investigator, significantly limits the visual acuity or view of the retina
- Cataract surgery within three months preceding baseline, or a history of post-operative complications within the last 12 months preceding baseline in the study eye (uveitis, cyclitis, etc.)
- Previous retinal or ocular surgery, the effects of which may now or in the future complicate assessment of CSCR (routine cataract surgery more than 3 months prior is permitted)
- Known hypersensitivity to fluorescein
- Use of any systemic or ocular medication known to be toxic to the retina, excluding tamoxifen unless there is evidence of toxicity
- Pregnant or lactating women
- Current participation in any other investigational ophthalmological clinical trial
- Other health-related reasons which make an individual inappropriate for participation in this study based on the investigator's medical judgment
Trial locations and contacts
2 sites in 1 country.
Australia2 sites, 2 recruiting
- Recruiting
Centre for Eye Research Australia
East Melbourne, Victoria, 3002
Carly Parfett, +61 3 9929 8263, cera-rgo@cera.org.au
Rebecca Singleton, +61399298369, cera-rgo@cera.org.au
- Recruiting
Retinology Institute
Glen Iris, Victoria, 3146
Wilson Heriot, MBBS FRANZCO, +61 3 8823 9000, info@retinology.com.au
About this study
Official title: Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy: A Double-masked Sham-controlled Randomised Trial
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.
Read more
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
- Being tested
- 2RT subthreshold nanosecond laser - active, 2RT subthreshold nanosecond laser - sham
- Keywords
- Subthreshold nanosecond laser, Laser, 2RT, CSR, Central Serous Chorioretinopathy, Chorioretinopathy
- Medical subject headings
- Central Serous Chorioretinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2RT subthreshold nanosecond laser - activeDevice
Also called 2RT, SNL
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.
2RT subthreshold nanosecond laser - shamDevice
Also called Sham laser
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.
| Study group | Role | What they receive |
|---|---|---|
| Active laser | Active comparator | Application of the active 2RT sub threshold laser Receives: 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) Receives: Device: 2RT subthreshold nanosecond laser - sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start18 Oct 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Eye Medical Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Center for Eye Research Australia
- Responsible party
- Sponsor
- Investigators
- Mali Okada, MBBS FRANZCO, Principal investigator, Center for Eye Research Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570591
- Sponsor's protocol ID
- NANO-C
- Acronym
- NANO-C
- Status last verified
- Jun 2024
- First submitted
- 4 Oct 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy: A Double-masked Sham-controlled Randomised Trial
- ClinicalTrials.gov ID
- NCT05570591
- Acronym / sponsor ID
- NANO-C / NANO-C
- Conditions
- Central Serous Chorioretinopathy
- Keywords
- Subthreshold nanosecond laser, Laser, 2RT, CSR, Central Serous Chorioretinopathy, Chorioretinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nova Eye Medical Pty Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Center for Eye Research Australia
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active laser | Active comparator | Device: 2RT subthreshold nanosecond laser - activeApplication of the active 2RT sub threshold laser |
| Sham laser | Sham comparator | Device: 2RT subthreshold nanosecond laser - shamApplication of sham laser (i.e. flashing lights which replicate the look of active laser to the participant) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (23 listed)
- 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:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2RT subthreshold nanosecond laser - activeAlso: 2RT, SNLThe 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. | Device | Active laser |
| 2RT subthreshold nanosecond laser - shamAlso: Sham laserApplication of sham laser (i.e. flashing lights which replicate the look of active laser to the participant) from the 2RT subthreshold nanosecond laser device. | Device | Sham laser |
Primary outcome
Resolution of sub-retinal fluid in study eyes
Time frame: 24 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mali Okada, MBBS FRANZCO principal investigator
Center for Eye Research Australia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2RT subthreshold nanosecond laser - active in people with Central Serous Chorioretinopathy, run by Nova Eye Medical Pty Ltd. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Spurling (+61 8 8362 0193, tspurling@nova-eye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of sub-retinal fluid in study eyes (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024.