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RECRUITINGINTERVENTIONAL

Photobiomodulation in Dry Age Related Macular Degeneration

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Concomitant epilepsy - Neurological diseases - Psychiatric pathologies - Herpes virus infections - Dense cataract - Pregnancy - Other significant ocular and/or retinal diseases Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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)

Locations (7)

University of Paris
Paris, France
Università degli Studi di Ferrara
Ferrara, Italy
Università degli studi della Campania Luigi Vanvitelli
Naples, Italy
Università di Torino
Torino, Italy
University of Ankara
Ankara, Turkey (Türkiye)
Koç University Hospital
Koç, Turkey (Türkiye)
Earlam and Christopher
Taunton, United Kingdom