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COMPLETED
NCT04065490
NA

Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III)

Sponsor: LumiThera, Inc.

View on ClinicalTrials.gov

Summary

This LIGHTSITE III study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD. Alcon Research, LLC, acquired LumiThera in September 2025.

Official title: A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE III)

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2019-09-23

Completion Date

2024-11-01

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

DEVICE

Valeda Light Delivery System

Light delivery system that produces multi-wavelength LED treatment at 590, 660 and 850 nanometers.

DEVICE

Valeda Light Delivery System Sham Mode

Sham light delivery system that emits an approximate 50 times and 100 times reduction in treatment dose for the 590 and 660 nm wavelengths respectively and no emission of the 850 nm wavelength.

Locations (10)

Retina Vitreous Associates Medical Group

Beverly Hills, California, United States

Stanford University

Palo Alto, California, United States

Florida Eye Clinic

Altamonte Springs, Florida, United States

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Mid Atlantic Retina

Cherry Hill, New Jersey, United States

New York Ear and Eye Infirmary

New York, New York, United States

Duke Eye Center

Durham, North Carolina, United States

Cumberland Valley Retina Consultants

Chambersburg, Pennsylvania, United States

Gulf Coast Eye Institute

McAllen, Texas, United States

Retina Center Northwest

Silverdale, Washington, United States