Photobiomodulation in Dry Age Related Macular Degeneration

Age-Related Macular Degeneration Clinical Trial

— DRUSEN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046118
• Other study ID #: PBM AMD
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
• Contact: Giuseppe Giannaccare
• Phone: 003909613647135
• Email: giuseppe.giannaccare[@]unicz.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

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).
• Sham Mask
Low light emission mask (Sham Mask, Espansione group, Bologna, Italy)

Locations

Country	Name	City	State
France	University of Paris	Paris
Italy	Università degli Studi di Ferrara	Ferrara
Italy	Università degli studi della Campania Luigi Vanvitelli	Napoli
Italy	Università di Torino	Torino
Turkey	University of Ankara	Ankara
Turkey	Koç University Hospital	Koç
United Kingdom	Earlam and Christopher	Taunton

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Countries where clinical trial is conducted

France,  Italy,  Turkey,  United Kingdom, 

Outcome

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