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)
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.
• 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.
• Diagnosis of dry AMD as defined by the presence of the following:
• 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
• Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
• Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines