Photobiomodulation in Dry Age Related Macular Degeneration

Study Overview
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Brief Summary
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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.

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

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Device: Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)
* Device: Sham Mask


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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). | Device: Yellow and red light emitting diode photobiomodulation (Eye Light, Espansione Group, Bologna, Italy)<br>* 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).<br>|
| Sham Comparator: Sham group<br>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). | Device: Sham Mask<br>* Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity variation | ETDRS letters | 1 month, 2 months and 4 months after each cycle | 
| Drusen Volume Variation | Based on SD-OCT Heidelberg | 1 month, 2 months and 4 months after each cycle | 
| Contrast sensitivity variation | Based on Pelli Robson chart | 1 month, 2 months and 4 months after each cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age related Macular Degeneration, Photobiomodulation