Trials / Active Not Recruiting
Active Not RecruitingNCT04065490
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III)
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)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- Sponsor
- LumiThera, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This LIGHTSITE III 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.
Detailed description
This study is a double-masked, sham-controlled, parallel design prospective, multi-site study on the use of photobiomodulation (PBM) as a treatment for visual impairment in subjects with dry AMD. Subjects will receive repeated sham or PBM treatments at several time-points throughout the 2-year study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Valeda PBM treatment | The Valeda Light Delivery System |
| DEVICE | Valeda Sham treatment | The sham mode of the Valeda Light Delivery System. |
Timeline
- Start date
- 2019-09-01
- Primary completion
- 2022-06-01
- Completion
- 2022-06-01
- First posted
- 2019-08-22
- Last updated
- 2021-02-05
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04065490. Inclusion in this directory is not an endorsement.