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Age-Related Macular DegenerationLIANANCT05200624

Subthreshold Laser Treatment in Intermediate Age-related Macular Degeneration With Nascent Geographic Atrophy Study

A study testing 2RT subthreshold nanosecond laser in people with Age-Related Macular Degeneration, run by Center for Eye Research Australia at 4 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is a prospective, single centre, randomized, sham-controlled, double-masked, clinical trial which aims to investigate the effect of subthreshold nanosecond laser on disease progression in eyes with intermediate age-related macular degeneration (AMD) and nascent geographic atrophy by functional and… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
2RT subthreshold nanosecond laser
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
4 sitesAustralia
Study dates
13 Dec 2021to 7 Apr 2025
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 50 years or older at time of consent
  • Best corrected visual acuity (BCVA) of 59 letters (Snellen equivalent of 6/19) or better in both eyes
  • Bilateral large (>125µm) drusen as seen on colour fundus photographs (CFP) as assessed within a circle with radius of 3000µm centred on the fovea
  • Between 1 to 5 (inclusive) discrete area/s of nascent geographic atrophy (nGA) as seen on SD-OCT B-scan/s within a 20°x20° volume scan centred on the fovea in the study eye NOTE: TThe non-study eye does not need to have nGA but can have: any number of nGA, iRORA or cRORA lesions (on OCT) but not GA (on CFP or FAF)
  • Ability, willingness and sufficient cognitive awareness to consent to the trial, received randomized SNL treatment or sham procedure, and complete all visits as per the study schedule

Who cannot join

  • STUDY EYE: A cluster of definitely present reticular pseudodrusen (RPD) of >1 disc area (DA) (i.e., an area approximately 2.54mm2 in size) as seen on near infrared (NIR) imaging, or fundus autofluorescence (FAF) within a 20˚x20˚ field centred on the fovea
  • STUDY EYE: A subfoveal pigment epithelial detachment (PED)/drusenoid detachment >1000µm in diameter (measured on the central B-scan) with hyperreflective foci (HRF) and increased choroidal transmission or any PED >2000µm measured at the central foveal B-scan
  • Any evidence of definite geographic atrophy (GA) in either eye
  • Any evidence of active, regressed or treated macular neovascularization (MNV), in either eye, or active peripapillary CNV in the study eye (determined on multi-modal imaging and a fundus fluorescein angiogram is only required if in the investigator's medical judgement) NB: Subretinal fluid (SRF) <100µm or SRF associated with a subfoveal pseudovitelliform lesion permitted (i.e. slither/draping/ vitelliform with no evidence of new vessels on OCT-A) is not considered MNV and can be enrolled.
  • Any other investigational treatment for AMD, excluding dietary supplements, received in the past 12 months or thought, in the opinion of the investigator, likely to chronically change the course of the subject's retinal disease
  • Current participation in any other investigational ophthalmological clinical trial
Show all 25Show fewer
  • Any ocular disease in the study eye, other than AMD, 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:
  • Diabetic retinopathy (unless limited to fewer than 10 microaneurysms and/or small retinal hemorrhages, without retinal thickening on OCT)
  • Macular pathology or pigmentary abnormalities atypical of AMD, including but not limited to: pattern dystrophy, myopic maculopathy, angioid streaks, resumed ocular histoplasmosis syndrome, central serous choroidopathy, 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 disc diameters (DD) of the fovea associated with depigmentation or overlying drusen, if these drusen are used to determine eligibility
  • Active uveitis or ocular inflammation
  • History or presence of uncontrolled glaucoma
  • 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 break and/or focal retinal tears 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
  • Previous retinal or ocular surgery, the effects of which may now or in the future complicate assessment of the progression of AMD. (Cataract surgery is allowed as long as it was performed over 90 days prior to entry into the study)
  • Known hypersensitivity to fluorescein
  • Sensitivity to application of a contact lens
  • 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.
  • 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
  • Subject who is considered ineligible for this study in the investigator's medical judgement

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Adelaide Eye & Retina Centre

    Adelaide, South Australia, 5000

  • Centre for Eye Research Australia

    East Melbourne, Victoria, 3002

  • Retinology Institute

    Melbourne, Victoria, 3167

  • Marsden Eye Specialists

    Parramatta, New South Wales, 2150

Other trials in Australia

About this study

This study is a prospective, single centre, randomized, sham-controlled, double-masked, clinical trial which aims to investigate the effect of subthreshold nanosecond laser on disease progression in eyes with intermediate age-related macular degeneration (AMD) and nascent geographic atrophy by functional and anatomical outcomes.

The study population will be individuals with high-risk intermediate age-related macular degeneration who meet all eligibility criteria. 60 subjects total (30 randomized to receive subthreshold nanosecond laser (SNL) treatment and 30 to receive sham treatment as per the 1:1 randomization).

Read more

The study has a 12-month study period with four scheduled visits: screening, randomisation (first treatment), 6-month follow up visit (with second treatment where eligible), 12-month follow-up.

The primary outcome is the proportion of laser-treated study eyes that develop late AMD compared to sham-treated study eyes over 12 months. The key secondary outcome is the change in retinal function of laser-treated study eyes compared to sham-treated study eyes over 12 months. Safety will be the proportion of laser-treated eyes that lose 10+ letters of vision (measured on a standard vision chart) compared to sham-treated eyes over 12 months.

Being tested
2RT subthreshold nanosecond laser
Keywords
Laser, Subthreshold nanosecond laser, Nascent geographic atrophy
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2RT subthreshold nanosecond laserDevice

    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.

Study groups in NCT05200624
Study groupRoleWhat they receive
Active laserActive comparatorApplication of the active 2RT sub threshold laser
Receives: Device: 2RT subthreshold nanosecond laser
Sham laserSham comparatorApplication of sham laser (i.e. flashing lights which replicate the look of active laser to the participant)
Receives: Device: 2RT subthreshold nanosecond laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of progression to advanced AMD in study eyes

    The time to develop advanced AMD - as defined as choroidal neovascularization (CNV), geographic atrophy (GA), or OCT-defined cRORA - in the SNL-treated compared to sham-treated study eyes over 12 months

    Measured: 12 months

Secondary outcomes (1)

  1. Rate of retinal sensitivity change in study eyes

    The rate of change in mean retinal sensitivity over time (in decibels per year) of the SNL-treated compared to sham-treated study eyes over 12 months.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2022
  2. Study start13 Dec 2021
  3. Primary completion28 Mar 2025
  4. Study completion7 Apr 2025

Why it stopped: Difficulty with meeting recruitment targets

Resources

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
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05200624
Sponsor's protocol ID
LIANA
Acronym
LIANA
Status last verified
Jun 2024
First submitted
9 Dec 2021
Last updated
15 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 2RT subthreshold nanosecond laser in people with Age-Related Macular Degeneration, run by Center for Eye Research Australia at 4 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 25 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: stopped early, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

The study was stopped early (reason given: Difficulty with meeting recruitment targets). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of progression to advanced AMD in study eyes (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05200624.

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 15 Apr 2025.

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