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NCT05570591: NANO-C
Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy
NA trial testing 2RT subthreshold nanosecond laser - active in Central Serous Chorioretinopathy in 60 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | Nova Eye Medical Pty Ltd. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 18 October 2022 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 2 locations across Australia |
Drugs / interventions tested
- 2RT subthreshold nanosecond laser - active
- 2RT subthreshold nanosecond laser - sham
Conditions studied
- Central Serous Chorioretinopathy — all drugs for Central Serous Chorioretinopathy →
Sponsor
Nova Eye Medical Pty Ltd.
Who can join
Adults 18 to 70, any sex, with Central Serous Chorioretinopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05570591
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Central Serous Chorioretinopathy
Currently open trials in the same condition.
- NCT06527326 — the Study of the Association Between the Gut Microbiota and Central Serous Chorioretinopathy · NA · recruiting
- NCT06346405 — Central Serous Chorioretinopathy and Micropulse Laser Treatment · recruiting
- NCT05589974 — Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05570591 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nova Eye Medical Pty Ltd.
- Last refreshed: 24 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05570591.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing