NCT06046118

Photobiomodulation in Dry Age Related Macular Degeneration

Outcomes of Photobiomodulation in DRy Age Related macUlar Degeneration: a proSpective multicEnter raNdomized Controlled (DRUSEN) Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate effects of consecutive Yellow and Red Light Emitting Diode photobiomodulation in dry age-related macular degeneration (AMD). The main questions it aims to answer are: * Is Yellow and Red Light Emitting Diode photobiomodulation effective in decreasing drusen volume in patients affected by dry AMD? * Does Yellow and Red Light Emitting Diode photobiomodulation increase visual acuity and contrast sensitivity in patients affected by dry AMD? Participants will be randomly assigned to a treatment or a sham group. Treatment consists in two cycles with two phases each: * 1st phase: 300 seconds of continuous Yellow light with eyes closed + 60 seconds of pulsed Yellow light with eyes opened; * 2d phase: 300 seconds of continuous Red light with eyes closed + 60 seconds of pulsed Red light with eyes opened. Cycle 1 consists of 8 sessions (two PBM per week for 4 weeks) and cycle 2 consists of 6 sessions (two PBM per week for 3 weeks). Researchers will compare patients in the treatment group to those in the sham group to evaluate differences in objective signs and subjective symptoms of dry AMD.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)	Each session consists of: * 1st phase: 300 seconds of continuous Yellow light (eyes closed) + 60 seconds of pulsed Yellow light (eyes opened) * 2nd phase: 300 seconds of continuous Red light(eyes closed) + 60 seconds of pulsed Red light (eyes opened). Cycle 1: 8 sessions (two PBM per week for 4 weeks); Cycle 2: 6 sessions (two PBM per week for 3 weeks).
DEVICE	Sham Mask	Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)

Timeline

• Start date: 2023-04-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-09-21
• Last updated: 2024-09-19

Locations

7 sites across 4 countries: France, Italy, Turkey (Türkiye), United Kingdom