Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE II)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03878420|
Recruitment Status : Active, not recruiting
First Posted : March 18, 2019
Last Update Posted : August 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dry Age-related Macular Degeneration||Device: Valeda PBM treatment Device: Valeda Sham treatment||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Valeda Light Delivery System|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE II)|
|Actual Study Start Date :||February 14, 2019|
|Estimated Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: PBM Treatment
The Valeda™ Light Delivery System will deliver 590, 660 and 850 nm wavelengths together.
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.
Sham Comparator: Sham Treatment
The Valeda™ Light Delivery System will deliver non-effective treatment of the 590 and 660 nm wavelengths together.
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.
- Best Corrected Visual Acuity [ Time Frame: Month 9 ]The primary efficacy endpoint will be the change in BCVA from Baseline to Month 9 as assessed using the ETDRS BCVA chart.
- Best Corrected Visual Acuity [ Time Frame: Month 9 ]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.
- Contrast Sensitivity [ Time Frame: Month 9 ]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).
- Impact on Central Drusen Volume by OCT [ Time Frame: Month 10 ]The analyses will first examine change from the screening visit in central Drusen volume
- Impact on Central Drusen Thickness by OCT [ Time Frame: Month 10 ]The analyses will then examine change from the screening visit in central Drusen Thickness
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03878420
|Institut ophtalmologique de l'Ouest- Clinique jules VERNE|
|Universitätsklinikum Freiburg- Klinik für Augenheilkunde|
|Freiburg, Germany, 79106|
|Klinik fur Ophthalmologie, Universitatsklinikum Schleswig-Holstein|
|Universitaetsmedizin Mainz- Augenklinik|
|Mainz, Germany, 55131|
|Osprdalr San Raffaele|
|Institut Català de Retina|
|James Paget University|
|Great Yarmouth, United Kingdom, NR31 6LA|
|Peterborough City Hospital|
|Peterborough, United Kingdom, PE3 9GZ|