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

NCT03878420 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-09-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Valeda PBM treatment

The Valeda Light Delivery System delivers 590, 660 and 850 nm wavelengths of light to the study eye. The Valeda Light Delivery System will treat through the open eyelid with the 590 nm and 850 nm wavelengths together. The 660 nm wavelength will be treated through the closed eyelid.

DEVICE

Valeda Sham treatment

The sham mode emits an approximate 100x reduction in the highest dose for the 660 nm wavelengths as compared to the treatment mode, producing a slightly duller light. The 850 nm (NIR) wavelength (which is not visible light) is not provided in the sham treatment.

Sponsors & Collaborators

  • LumiThera, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2021-01-22
Completion
2021-01-22

Countries

  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03878420 on ClinicalTrials.gov