NCT04522999

Study of Photobiomodulation Effect on Electroretinogram Outcomes in Dry Age-Related Macular Degeneration

An Objective Study to Evaluate the Ability of Photobiomodulation to Improve Electroretinogram Outcomes in Subjects With Dry Age-Related Macular Degeneration

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: LumiThera, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the ability of Photobiomodulation (PBM) treatment using the Valeda® Light Delivery System to improve Electroretinogram (ERG) outcomes in subjects with dry Age-related Macular Degeneration (AMD).

Detailed description

This study is an open label, prospective pilot study to evaluate retinal function after PBM treatment in eyes with dry AMD using ERG. The target enrollment is 15 subjects in up to two sites in the US. All subjects will receive PBM Treatment. Subjects will receive three PBM treatments per week for three weeks for a total of nine sessions over 3 weeks. The primary analysis will examine multi-focal ERG function changes from baseline to Month 1. Secondary analyses will examine multi-focal ERG function change from baseline to Month 3 and 6. Other endpoints will include other functions of ERG, ETDRS Visual Acuity, Contrast Sensitivity, Perimetry, Color Vision test and the Amsler grid test.

Conditions

• Age Related Macular Degeneration

Interventions

Type	Name	Description
DEVICE	Photobiomodulation	The Valeda™ Light Delivery System

Timeline

• Start date: 2020-08-20
• Primary completion: 2021-08-13
• Completion: 2021-08-13
• First posted: 2020-08-21
• Last updated: 2021-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study