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

Phase 2

Active, not recruiting

• Conditions: Dry Age-related Macular Degeneration
• Interventions: Device: Valeda Light Delivery System

• Registration Number: NCT06229665
• Lead Sponsor: LumiThera, Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-10-25
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photobiomodulation (PBM)	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.

Primary Outcome Measures

Name	Time	Method
Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA)	12 months	Mean change from baseline in BCVA.

Secondary Outcome Measures

Name	Time	Method
Geographic Atrophy (GA)	12 months	Number of new onset GA
Low Luminance BCVA	12 months	Mean change from baseline in the LLBVCA.
Contrast Seensitivity	12 months	Mean change from baseline (pre-treatment) in contrast sensitivity at 80 cm and 120 cm.

Trial Locations

Locations (7)

Retina Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Florida Eye Clinic; 🇺🇸 Altamonte Springs, Florida, United States

Cumberland Valley Retina Consultants; 🇺🇸 Hagerstown, Maryland, United States

New York Ear and Eye Infirmary; 🇺🇸 New York, New York, United States

Gulf Coast Eye Institute; 🇺🇸 McAllen, Texas, United States

Retina Center Northwest; 🇺🇸 Silverdale, Washington, United States