An interventional study of Valeda PBM treatment and Valeda Sham treatment in Dry Age-related Macular Degeneration, sponsored by LumiThera, Inc.. Active, not recruiting at 11 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-02-05.
Sponsored by LumiThera, Inc. · Not applicable, Interventional, and Treatment
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.
This study is a double-masked, sham-controlled, parallel design prospective, multi-site study on the use of photobiomodulation (PBM) as a treatment for visual impairment in subjects with dry AMD. Subjects will receive repeated sham or PBM treatments at several time-points throughout the 2-year study.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 96 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →LumiThera, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Current or history of neovascular maculopathy that includes any of the following (to be confirmed by the reading center):
The Valeda™ Light Delivery System
Device: Valeda PBM treatment
The Valeda™ Light Delivery System non-effective treatment
Device: Valeda Sham treatment
The Valeda Light Delivery System
The sham mode of the Valeda Light Delivery System.
Best Corrected Visual Acuity
Mean change from baseline in BCVA.
Time frame: 21 months
Contrast Sensitivity
Mean change from baseline (pre-treatment) in contrast sensitivity at 40 cm.
Time frame: 21 months
Central Drusen Volume
Mean change from baseline (pre-treatment) in central Drusen volume.
Time frame: 21 Months
Central Drusen Thickness
Mean change from baseline (pre-treatment) in central Drusen thickness.
Time frame: 21 Months
Contrast Sensitivity
Mean change from baseline (pre-treatment) in contrast sensitivity at 80 cm and 120 cm.
Time frame: 21 Months
Visual Function Questionnaire
Mean change from baseline (pre-treatment) in Visual Function Questionnaire (VFQ-25) composite score.
Time frame: 21 Months
Reading Speed
Mean change from baseline (pre-treatment) to Month 21 in monocular reading speed assessed by the Radner Reading Chart.
Time frame: 21 Months
Geographic Atrophy
Mean change from baseline in the GA lesion area of the PBM treatment group versus the sham treatment group, as measured by FAF.
Time frame: 21 Months
Low Luminance- Best Corrected Visual Acuity
Mean change from baseline in the LLBVCA.
Time frame: 21 Months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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LumiThera, Inc.