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

Dry Age-related Macular Degeneration Clinical Trial

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 II)

Status Completed

Clinical Trial Summary

This LIGHTSITE II 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.

Clinical Trial Description

This 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. The target enrollment is 96 subjects in up to 10 centers in Europe, randomized at a 1:2 ratio into 2 groups: Sham Treatment (S-1) and PBM Treatment (T-2). Once 96 subjects have been enrolled in the study, if there are less than 144 eyes that qualify for the study, additional subjects will be enrolled until 144 eyes have been included in the study.

S-1 will receive 3 sham treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4 and 8. T-2 will receive 3 PBM treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4 and 8. Each treatment series will total 9 treatments. Neither the subject nor the study staff will know which treatment the subject has been assigned.

Subjects will receive standard visual outcome measurements including Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA, CSV-1000E contrast sensitivity (CS) and the Radner Reading Test prior to and following each treatment series as well as eye exams, fundus photographs, Heidelberg OCT and FAF imaging and optional Optos Ultra Wide Field (UWF) imaging of the retina at selected time intervals. Subjects will also complete the Visual Function Questionnaire 25 (VFQ-25) at selected time intervals. ;

Related Conditions & MeSH terms

• Dry Age-related Macular Degeneration
• Macular Degeneration

• NCT number: NCT03878420
• Study type: Interventional
• Source: LumiThera, Inc.
• Status: Completed
• Phase: N/A
• Start date: February 14, 2019
• Completion date: January 22, 2021