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

NCT05200624 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-04-15

No results posted yet for this study

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

Interventions

DEVICE

2RT subthreshold nanosecond laser

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.

Sponsors & Collaborators

  • Center for Eye Research Australia

    lead OTHER

Principal Investigators

  • Robyn H Guymer, MBBS FRANZCO · Center for Eye Research Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-13
Primary Completion
2025-03-28
Completion
2025-04-07

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05200624 on ClinicalTrials.gov