Photobiomodulation in Dry Age Related Macular Degeneration

Not Applicable

Recruiting

• Conditions: Age-Related Macular Degeneration

• Registration Number: NCT06046118
• Lead Sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2023-09
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Last Update Submitted: 2023-09-14
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (7)

University of Paris; 🇫🇷 Paris, France

Università degli Studi di Ferrara; 🇮🇹 Ferrara, Italy

Università degli studi della Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy

Università di Torino; 🇮🇹 Torino, Italy

University of Ankara; 🇹🇷 Ankara, Turkey

Koç University Hospital; 🇹🇷 Koç, Turkey

Earlam and Christopher; 🇬🇧 Taunton, United Kingdom