A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (GLOBALIGHT)

Part of paid clinical trials in Beverly Hills, California.

Sponsor
LumiThera, Inc.
Study ID
NCT06351605
Status
Recruiting
Apply to this trial

Conditions

  • Dry Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Valeda® Light Delivery System — DEVICE
    FDA-approved, multi-wavelength light delivery system for providing a pre-set treatment of pulsed light in 3 distinct wavelengths (PBM) to the participant's eye and retinal tissue through the open and closed eyelid. The Valeda Light Delivery System is a CE Marked Class IIa device in Europe (Certificate # CE 653115) and a Class 2 device in the United States (DEN230083).

Study Details

The purpose of this registry study is to collect real life data pertaining to the safety and clinical effectiveness of multi-wavelength photobiomodulation (PBM) as provided by the Valeda Light Delivery System in participants with dry age-related macular degeneration (AMD) in routine clinical practice. Data will be collected retrospectively and prospectively. PBM involves the use of visible light to near infrared light (NIR) (500-1000 nanometers) produced by a laser or a non-coherent light source applied to the surface of the body to activate mitochondrial respiratory chain components, stabilize metabolic function, and promote cellular proliferation. This registry study will be conducted in Europe, the US, and select other countries approved by their regulatory agency. This registry study was initiated as a combined retrospective and prospective data collection effort. After the acquisition of LumiThera by Alcon Research, LLC in September 2025, the study was amended to prospectively collect data from U.S. sites starting in July 2026.

Key Dates

First listed
Apr 8, 2024
Start date
Sep 1, 2023
Status verified
Aug 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Photobiomodulation (PBM)
    Two alternating and sequential treatments with the Valeda Light Delivery System of 590 nm and 850 nm for 35 seconds, or a total of 70 seconds, followed by 660 nm for 90 seconds, or a total of 180 seconds

Primary Outcome Measure

Change in Visual Acuity from Baseline at each Treatment Visit [ Time Frame: Baseline (Day 0) pre-treatment; up to Month 31/exit ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Retina Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Retina Associates of KentuckyLexingtonKentucky40509-
Ichan School of Medicine at Mount SinaiNew YorkNew York10029-
Carolina Eyecare PhysiciansCharlestonSouth Carolina29414-
Valley Retina InstituteMcAllenTexas78503-
Pacific Northwest RetinaSilverdaleWashington98383-

Find similar trials in Beverly Hills, CA

By research site
Retina Vitreous Associates Medical Group· Beverly Hills, CARetina Associates of Kentucky· Lexington, KYIchan School of Medicine at Mount Sinai· New York, NYCarolina Eyecare Physicians· Charleston, SCValley Retina Institute· McAllen, TXPacific Northwest Retina· Silverdale, WA

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