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.
This 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. The target enrollment is 96 subjects in up to 10 centers in Europe, randomized at a 1:2 ratio into 2 groups: Sham Treatment (S-1) and PBM Treatment (T-2). Once 96 subjects have been enrolled in the study, if there are less than 144 eyes that qualify for the study, additional subjects will be enrolled until 144 eyes have been included in the study. S-1 will receive 3 sham treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4 and 8. T-2 will receive 3 PBM treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4 and 8. Each treatment series will total 9 treatments. Neither the subject nor the study staff will know which treatment the subject has been assigned. Subjects will receive standard visual outcome measurements including Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA, CSV-1000E contrast sensitivity (CS) and the Radner Reading Test prior to and following each treatment series as well as eye exams, fundus photographs, Heidelberg OCT and FAF imaging and optional Optos Ultra Wide Field (UWF) imaging of the retina at selected time intervals. Subjects will also complete the Visual Function Questionnaire 25 (VFQ-25) at selected time intervals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
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.
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.
Institut ophtalmologique de l'Ouest- Clinique jules VERNE
Nantes, France
Universitätsklinikum Freiburg- Klinik für Augenheilkunde
Freiburg im Breisgau, Germany
Klinik fur Ophthalmologie, Universitatsklinikum Schleswig-Holstein
Kiel, Germany
Universitaetsmedizin Mainz- Augenklinik
Mainz, Germany
Best Corrected Visual Acuity
The primary efficacy endpoint will be the change in BCVA from Baseline to Month 9 as assessed using the ETDRS BCVA chart.
Time frame: Month 9
Best Corrected Visual Acuity
The first of the secondary analyses will test the difference between the sham-treated and PBM-treated subjects in mean change from baseline (pre-treatment) to Month 9 in BCVA.
Time frame: Month 9
Contrast Sensitivity
The second of the secondary analyses will test the difference between the sham-treated and PBM-treated subjects in mean change from baseline (pre-treatment) to Month 9 in contrast sensitivity at 18 cycles/degree (CPD).
Time frame: Month 9
Impact on Central Drusen Volume by OCT
The analyses will first examine change from the screening visit in central Drusen volume
Time frame: Month 10
Impact on Central Drusen Thickness by OCT
The analyses will then examine change from the screening visit in central Drusen Thickness
Time frame: Month 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Osprdalr San Raffaele
Milan, Italy
Institut Català de Retina
Barcelona, Spain
James Paget University
Great Yarmouth, United Kingdom
Peterborough City Hospital
Peterborough, United Kingdom