Photobiomodulation for Age-Related Macular Degeneration

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: LumiThera, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study is an open-label, prospective, multi-center extension study on the continued use of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) that participated in the CSP005 LIGHTSITE III study.

Eligibility Criteria

This trial is for individuals who completed the CSP005 study, have dry age-related macular degeneration (AMD) with certain vision scores, and can follow the study requirements. They must not have other eye diseases that affect vision or a history of light sensitivity, recent invasive eye surgery, serious illnesses, cancer in the past 5 years (with exceptions), or substance abuse.

Inclusion Criteria

ETDRS BCVA letter score of between 50 and 75 (Snellen equivalent of 20/100 to 20/32) at Baseline

Participation in and completion of CSP005 study

Able to communicate well with the Investigator and able to understand and comply with the requirements of the study

+2 more

Exclusion Criteria

Presence or history of known light sensitivity to yellow light, red light, or near infrared radiation

In the opinion of the Investigator, is unlikely to comply with the study protocol

I have or had a type of eye disease affecting my vision.

+16 more

Participant Groups

The LIGHTSITEIIIB trial tests ongoing use of photobiomodulation (PBM) using the Valeda Light Delivery System on people with dry AMD who participated in a previous related study. It's an open-label extension meaning participants and researchers know what treatment is being used.

1Treatment groups

Experimental Treatment

Group I: Photobiomodulation (PBM)Experimental Treatment1 Intervention

The Valeda Light Delivery System will deliver two alternating and sequential treatments of 590 nm and 850 nm for 35 seconds, or a total of 70 seconds; and 660 nm for 90 seconds, or a total of 180 seconds.