Photobiomodulation in Dry Age Related Macular Degeneration (DRUSEN)

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Status: Enrolling

Conditions: Age-Related Macular Degeneration

Treatments: Device: Sham Mask; Device: Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)

Study type: Interventional

Funder types: Other

Identifiers

NCT06046118

PBM AMD

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BCVA ETDRS > 40 L ETDRS at 4 meters
• Diagnosis of DRY AMD AREDS grade 2-3
• Ability to communicate well with the investigator and able to understand and comply with the requirements of the study

Exclusion criteria

• Concomitant epilepsy
• Neurological diseases
• Psychiatric pathologies
• Herpes virus infections
• Dense cataract
• Pregnancy
• Other significant ocular and/or retinal diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Treatment group

Experimental group

Description:

Two cycles of treatment using continuous and pulsed yellow light followed by continuous and pulsed red light. Cycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks).

Treatment:

Device: Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)

Sham group

Sham Comparator group

Description:

Sham treatment will occur using a sham mask, designed to release a very low level of light, in this way the patient will not be able to distinguish if he is receiving the treatment or not. Cycle 1 consists of 8 sessions (two sessions per week for 4 weeks) and cycle 2 consists of 6 sessions (two sessions per week for 3 weeks).

Treatment:

Device: Sham Mask