Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III)
|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: NCT04065490|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2019
Last Update Posted : February 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Dry Age-related Macular Degeneration||Device: Valeda PBM treatment Device: Valeda Sham treatment||Not Applicable|
|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 III)|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2022|
Experimental: PBM Treatment
The Valeda™ Light Delivery System
Device: Valeda PBM treatment
The Valeda Light Delivery System
Sham Comparator: Sham Treatment
The Valeda™ Light Delivery System non-effective treatment
Device: Valeda Sham treatment
The sham mode of the Valeda Light Delivery System.
- Best Corrected Visual Acuity [ Time Frame: 21 months ]Mean change from baseline in BCVA.
- Contrast Sensitivity [ Time Frame: 21 months ]Mean change from baseline (pre-treatment) in contrast sensitivity at 40 cm.
- Central Drusen Volume [ Time Frame: 21 Months ]Mean change from baseline (pre-treatment) in central Drusen volume.
- Central Drusen Thickness [ Time Frame: 21 Months ]Mean change from baseline (pre-treatment) in central Drusen thickness.
- Contrast Sensitivity [ Time Frame: 21 Months ]Mean change from baseline (pre-treatment) in contrast sensitivity at 80 cm and 120 cm.
- Visual Function Questionnaire [ Time Frame: 21 Months ]Mean change from baseline (pre-treatment) in Visual Function Questionnaire (VFQ-25) composite score.
- Reading Speed [ Time Frame: 21 Months ]Mean change from baseline (pre-treatment) to Month 21 in monocular reading speed assessed by the Radner Reading Chart.
- Geographic Atrophy [ Time Frame: 21 Months ]Mean change from baseline in the GA lesion area of the PBM treatment group versus the sham treatment group, as measured by FAF.
- Low Luminance- Best Corrected Visual Acuity [ Time Frame: 21 Months ]Mean change from baseline in the LLBVCA.
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): NCT04065490
|United States, California|
|Retina Vitreous Associates Medical Group|
|Beverly Hills, California, United States, 90211|
|Palo Alto, California, United States, 94303|
|United States, Florida|
|Florida Eye Clinic|
|Altamonte Springs, Florida, United States, 32701|
|United States, Maryland|
|Cumberland Valley Retina Consultants|
|Hagerstown, Maryland, United States, 21749|
|United States, New Jersey|
|Mid Atlantic Retina|
|Cherry Hill, New Jersey, United States, 19107|
|United States, New York|
|New York Ear and Eye Infirmary|
|New York, New York, United States, 10003-4284|
|United States, North Carolina|
|Duke Eye Center|
|Durham, North Carolina, United States, 27705|
|United States, Pennsylvania|
|Cumberland Valley Retina Consultants|
|Chambersburg, Pennsylvania, United States, 17201|
|United States, Texas|
|Gulf Coast Eye Institute|
|McAllen, Texas, United States, 78503|
|Retina Consultants of Houston|
|The Woodlands, Texas, United States, 77384|
|United States, Washington|
|Retina Center Northwest|
|Silverdale, Washington, United States, 98383|