Photobiomodulation in Dry Age Related Macular Degeneration

NCT06046118 | Recruiting

• 1 other identifier: PBM AMD
• Study Type: interventional
• Target: 180
• Locations: 4 countries
• Sites: 7

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.

Conditions

Age-Related Macular Degeneration

Keywords

Age related Macular Degeneration; Photobiomodulation

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Treatment group

EXPERIMENTAL

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)

Sham group

SHAM COMPARATOR

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

Interventions

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

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).

Treatment group

Sham Mask DEVICE

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

Sham group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Mater Domini, Catanzaro: lead

Study Sites (7)

University of Paris

Paris, France

RECRUITING

Università degli Studi di Ferrara

Ferrara, Italy

RECRUITING

Università degli studi della Campania Luigi Vanvitelli

Napoli, Italy

RECRUITING

Università di Torino

Torino, Italy

RECRUITING

University of Ankara

Ankara, Turkey (Türkiye)

RECRUITING

Koç University Hospital

Koç, Turkey (Türkiye)

RECRUITING

Earlam and Christopher

Taunton, United Kingdom

RECRUITING

Related Publications (1)

• Borrelli E, Coco G, Pellegrini M, Mura M, Ciarmatori N, Scorcia V, Carnevali A, Lucisano A, Borselli M, Rossi C, Reibaldi M, Ricardi F, Vagge A, Nicolo M, Forte P, Cartabellotta A, Hasanreisoglu M, Kesim C, Demirel S, Yanik O, Bernabei F, Rothschild PR, Farrant S, Giannaccare G. Safety, Tolerability, and Short-Term Efficacy of Low-Level Light Therapy for Dry Age-Related Macular Degeneration. Ophthalmol Ther. 2024 Nov;13(11):2855-2868. doi: 10.1007/s40123-024-01030-w. Epub 2024 Sep 13.

  PMID: 39271642 DERIVED

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Giuseppe Giannaccare

CONTACT

003909613647135; giuseppe.giannaccare@unicz.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1); TU (2); IT (3); GB (1)