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

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: LumiThera, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Inclusion Criteria

Male or female at least 50 years of age at Screening visit

ETDRS BCVA letter score of between 50* and 75* (Snellen equivalent of 20/100 to 20/32). *If the subject meets this criterion at the Screening Visit, but the Baseline BCVA letter score is between 48 and 77, the subject may be entered in the study.

Drusen that are intermediate in size or larger (63 μm or larger in diameter) with at least a few (3) being regular drusen and not pseudodrusen and/or geographic atrophy (GA) visible on two of the following: color fundus images, OCT and/or FAF, to be confirmed by the reading center

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