Repeated Low-Level Red-Light Therapy in Dry Age-Related Macular Degeneration

Summary

This prospective, double-blind, randomized controlled trial aims to evaluate the efficacy and safety of repeated low-level red-light (RLRL) therapy in patients with dry age-related macular degeneration (AMD). The primary objective is to assess the effect of RLRL therapy on visual function in patients with dry AMD, while the secondary objective is to evaluate its safety and tolerability.

Seventy-four participants aged 50 years or older with dry AMD will be enrolled and randomly assigned in a 1:1 ratio to either the active RLRL intervention group (using the full device power) or the control group (sham device at 10% power). Group assignments will be masked to both participants and investigators. Participants will administer the treatment at home twice daily (3-minute sessions, with at least a 4-hour interval between sessions) over five consecutive weekdays each month for three months. A video tutorial will guide device usage, with ongoing support from the research team.

Before enrollment, participants will undergo a comprehensive assessment, including ocular and family history review, OCT, and fundus photography to confirm eligibility. Evaluations will occur at baseline, 1 month, and 3 months, covering best-corrected visual acuity (BCVA), slit-lamp examination, OCT, OCT angiography (OCTA), fundus autofluorescence (FAF), contrast sensitivity, color vision, electroretinography (ERG), visual-related quality of life (VRQL) questionnaires, and adverse event monitoring.

The primary outcome is the mean change in BCVA from baseline to 3 months. Secondary outcomes include changes in central drusen thickness, geographic atrophy (GA) size and progression, choroidal blood flow, contrast sensitivity, ERG responses, and VRQL scores.

Given the limited treatment options for dry AMD, which are primarily focused on lifestyle changes and nutritional supplements, this study investigates the potential of RLRL therapy as a novel, non-invasive treatment. The results may address the unmet medical need in dry AMD, potentially slowing disease progression and improving patients' quality of life.

Conditions

• AMD - Age-Related Macular Degeneration

Interventions

DEVICE

Sham device

Each participant in the sham group will be provided a sham therapy device, which they are required to use twice daily for 3minutes per session, with a minimum interval of 4 hours between sessions (5 days a week) for three month.

DEVICE

RLRL device

Each participant in the RLRL therapy group will be provided a repeated low-level red-light therapy (RLRL) device, which they are required to use twice daily for 3minutes per session, with a minimum interval of 4 hours between sessions (5 days a week) for three month.

Sponsors & Collaborators

• The Hong Kong Polytechnic University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-26

Primary Completion

2026-12-01

Completion

2026-12-01

Countries

• China

Study Locations