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

NCT05200624 | Terminated

• 1 other identifier: LIANA
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief 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 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). 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.

Conditions

Age-Related Macular Degeneration

Keywords

Laser; Subthreshold nanosecond laser; Nascent geographic atrophy

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (1)

• Rate of retinal sensitivity change in study eyes

  12 months

Other Outcomes (1)

• Safety Endpoint: Proportion of study eyes with a ≥10-letter loss in best-corrected visual acuity (BCVA)

  12 months

Study Arms (2)

Active laser

ACTIVE COMPARATOR

Application of the active 2RT sub threshold laser

Device: 2RT subthreshold nanosecond laser

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

Interventions

2RT subthreshold nanosecond laser 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; Sham laser

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Center for Eye Research Australia: lead

Study Sites (4)

Marsden Eye Specialists

Parramatta, New South Wales, 2150, Australia

Location

Adelaide Eye & Retina Centre

Adelaide, South Australia, 5000, Australia

Location

Centre for Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Retinology Institute

Melbourne, Victoria, 3167, Australia

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Robyn H Guymer, MBBS FRANZCO

  Center for Eye Research Australia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 21, 2022
• Study Start: December 13, 2021
• Primary Completion: March 28, 2025
• Study Completion: April 7, 2025
• Last Updated: April 15, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)