A Phase 2/3 interventional study of Valeda Light Delivery System in Dry Age-related Macular Degeneration, sponsored by LumiThera, Inc.. Active, not recruiting at 7 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by LumiThera, Inc. · Phase 2/3, Interventional, and Treatment
This study is an open-label, prospective, multi-center extension study on the continued use of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) that participated in the CSP005 LIGHTSITE III study.
This study is an open-label, prospective, multi-center study on the use of PBM as a treatment for visual impairment in subjects with dry AMD. Subjects diagnosed with dry AMD who meet all inclusion criteria and have none of the exclusion criteria will be eligible to participate in this clinical study. All subjects will be treated with the Valeda Light Delivery System and will receive PBM treatment for a total of 9 treatments over a three to five-week period (3 times per week for 3 weeks is preferable). There will be a re-treatment period starting at the 4-month time point to include 9 additional treatment visits, to be repeated again at 8 months and 12 months. LumiThera will use settings for the 3 wavelengths that were used in the CSP005 study. The subject population for this study will consist of all subjects that completed the CSP005 study, meet the inclusion/exclusion criteria for the CSP010 study, are interested in study participation and have signed the Informed Consent Form.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 75 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.
Entry Criteria: Inclusion Criteria (each eye qualifies for the study independently):
Exclusion Criteria (each eye qualifies for the study independently):
Current or history of neovascular maculopathy that includes any of the following (to be confirmed by the reading center):
The Valeda Light Delivery System will deliver two alternating and sequential treatments of 590 nm and 850 nm for 35 seconds, or a total of 70 seconds; and 660 nm for 90 seconds, or a total of 180 seconds.
Device: Valeda Light Delivery System
The Valeda Light Delivery System will deliver two alternating and sequential treatments of 590 nm and 850 nm for 35 seconds, or a total of 70 seconds; and 660 nm for 90 seconds, or a total of 180 seconds.
Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA)
Mean change from baseline in BCVA.
Time frame: 12 months
Low Luminance BCVA
Mean change from baseline in the LLBVCA.
Time frame: 12 months
Contrast Seensitivity
Mean change from baseline (pre-treatment) in contrast sensitivity at 80 cm and 120 cm.
Time frame: 12 months
Geographic Atrophy (GA)
Number of new onset GA
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
LumiThera, Inc.