Subthreshold Nanosecond Laser for Non-resolving Central Serous Chorioretinopathy: A Double-masked Sham-controlled Randomised Trial (NANO-C)

Age
18 years - 70 years
Gender
All
Phase
N/A
Participants needed
60
Locations
2

Brief description of study

This is a prospective, multicentre, sham-controlled, participant- and assessor-maskeduperiority trial with two parallel treatment arms which aims to investigate the safety andicacy of subthreshold nanosecond laser (SNL) in a series of adults with sub-retinal fluidcondary to non-resolving central serous chorioretinopathy (CSCR) by visual and anatomicalutcomes.
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 treatmentnd 20 to receive sham treatment as per a 2:1 randomization schedule and stratified by typeCSCR (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-up18-week follow-up, and 24-week follow-up.
The primary outcome is the proportion of laser-treated study eyes that show resolution ofub-retinal fluid (SRF) as observed on optical coherence tomography (OCT) compared toham-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 fellowyes over 24 weeks.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Central Serous Chorioretinopathy
  • Age: 18 years - 70 years
  • Gender: All

Inclusion Criteria:
  1. Age 18-70 years
  2. Both males and females
  3. Individuals with non-resolving CSCR as defined by presence of any SRF on OCT for > 3nths from date of diagnosis to randomisation visit
  4. BCVA of 35 to 80 letters (Snellen equivalent of 6/6 to 6/60) in the study eye
  5. Ability, willingness and sufficient cognitive awareness to consent to the trial,ceived randomised SNL treatment or sham procedure, and complete all visits as perthe study schedule
Exclusion Criteria:
  1. A need for extraneous, continuous steroids to control any disease, including bothystemic steroids (e.g., for systemic autoimmune conditions) and ocular steroids(e.g., for uveitis), or ongoing anabolic steroid use
  2. Any systemic disease that leads to elevated endogenous steroid levels including raised24h urinary cortisol level > 100 ug/24h consistent with Cushing's syndrome
  3. Any ocular disease in the study eye, other than CSCR, which in the opinion of theinvestigator may significantly compromise assessment of the retina, or which wouldcompromise the ability to assess any effect following SNL treatment including, but notimited to:
    • Age related macular degeneration
    • Any evidence of a neovascular membrane in the macular (either exudative ornon-exudative)
    • Diabetic retinopathy (unless limited to fewer than 10 microaneurysms and/or smalltinal haemorrhages, without retinal thickening on OCT)
    • Macular pathology or pigmentary abnormalities including but not limited to:pattern dystrophy, myopic maculopathy, angioid streaks, resumed ocularhistoplasmosis syndrome, visually-significant epiretinal membranes, macular holepseudohole
    • Optic nerve pathology, including optic atrophy, history of optic neuropathy
    • Myopic crescent wider than 50% of the longest diameter of the optic disc, orcloser 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 orverlying drusen, if these drusen are used to determine eligibility
    • Active uveitis or ocular inflammation
    • Corneal pathology precluding visualization of fundus or increasing the risk ofusing a contact lens, such as corneal dystrophy, recurrent corneal erosionyndrome or sensitivity to the application of a contact lens
  4. History or presence of uncontrolled glaucoma or raised intraocular pressure which
    would preclude safe dilation of the pupil to allow adequate assessment and applicationL treatment
  5. History of prior laser surgery to the retina including subthreshold laser (focaltinopexy for a peripheral retinal tear performed more than 90 days prior to thentry into the study is permitted)
  6. Significant cataract or other ocular media which, in the opinion of the investigator,ignificantly limits the visual acuity or view of the retina
  7. Cataract surgery within three months preceding baseline, or a history ofpost-operative complications within the last 12 months preceding baseline in the studyye (uveitis, cyclitis, etc.)
  8. Previous retinal or ocular surgery, the effects of which may now or in the futurecomplicate assessment of CSCR (routine cataract surgery more than 3 months prior ispermitted)
  9. Known hypersensitivity to fluorescein
  10. Use of any systemic or ocular medication known to be toxic to the retina, excludingtamoxifen unless there is evidence of toxicity
  11. Pregnant or lactating women
  12. Current participation in any other investigational ophthalmological clinical trial
  13. Other health-related reasons which make an individual inappropriate for participationin this study based on the investigator's medical judgment

Updated on 04 Aug 2024. Study ID: NANO-C
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting referrals by invitation only