LumiThera has developed a device to treat Dry early and Intermediate AMD (link to our AMD section) and the device has been granted a CE mark (i.e. was approved for clinical use in EU and UK). The Valeda™ Light Delivery System provides a light-based therapy called Photobiomodulation (PBM) to the retinal tissue.
What is PBM?
PBM is the application of specific wavelengths of light to the eye. The light source is Light Emitting Diodes (LED) which are very low powered and do not cause any heat damage to the eye. This is NOT a laser device. Light can produce many beneficial effects on cells and has been shown in previous studies to have a protective and regenerative effect on retinal cells. The wavelengths used by this device have been approved by the FDA for use in medical conditions such as periorbital wrinkles or rhytides, temporary relief of minor muscle and joint pain, arthritis and muscle spasm, and to temporarily improve local blood circulation in areas where it is applied.
Studies
Torpa Study
The Toronto and Oak Ridge pilot study of PBM in Dry AMD (TORPA) was the initial study that showed a statistically significant improvement in vision and contrast sensitivity in 22 eyes. Results were presented at the Association of Research and Vision in Ophthalmology (ARVO) meeting in 2012. There were no adverse events noted. The results have been published in the Proceedings of the 9th World Association for Laser Therapy Congress (WALT) 2012.
Torpa II Study
A follow up study, called the TORPA II, analyzed the efficacy of PBM treatment for patients with dry AMD in 42 eyes. The TORPA II study demonstrated similar improvement in vision and contrast sensitivity in addition to reductions in drusen volume and central drusen thickness. This study extended the previous findings of improved functional outputs with positive efficacy in anatomical outcomes. These data were peer-reviewed and published (Merry et al., Acta Opthalmologica; 95, e270-e277; 2016).
LIGHTSITE I study
The LIGHTSITE I study conducted by LumiThera and using the Valeda Light Delivery System was conducted in Canada, with 30 subjects with Dry AMD.
This study investigated the efficacy and safety of PBM treatment in subjects with Dry AMD. Thirty subjects (46 eyes) were treated with the Valeda™ Light Delivery System, wherein subjects underwent two series of treatments (3× per week for 3-4 weeks) over 1 year. Outcome measures included best-corrected visual acuity, contrast sensitivity, microperimetry, central drusen volume and drusen thickness, and quality of life assessments. PBM-treated subjects showed a best-corrected visual acuity mean letter score gain of 4 letters immediately after each treatment series at Month 1 (M1) and Month 7 (M7). Approximately 50% of PBM-treated subjects showed improvement of ≥5 letters versus 13.6% in sham-treated subjects at M1. High responding subjects (≥5-letter improvement) in the PBM-treated group showed a gain of 8 letters after initial treatment (P < 0.01) and exhibited earlier stages of age-related macular degeneration disease. Statistically significant improvements in contrast sensitivity, central drusen volume, central drusen thickness, and quality of life were observed (P < 0.05). No device-related adverse events were reported. In conclusion, PBM treatment statistically improved clinical and anatomical outcomes with more robust benefits observed in subjects with earlier stages of dry age-related macular degeneration. Repeated PBM treatments may be necessary to maintain benefits. These pilot findings support previous reports and suggest the utility of PBM as a therapy in subjects with Dry AMD.
LIGHTSITE IIII clinical trial
The LIGHTSITE IIII clinical trial demonstrated positive effects of photobiomodulation, 55% of the subjects showed a 5 or more letters improvement following a 13 month clinical study.
PBM is NOT suitable for patients who have or have been treated for wet age-related macular degeneration, or those with epilepsy or light sensitivity.
Torpa Study
The Toronto and Oak Ridge pilot study of PBM in Dry AMD (TORPA) was the initial study that showed a statistically significant improvement in vision and contrast sensitivity in 22 eyes. Results were presented at the Association of Research and Vision in Ophthalmology (ARVO) meeting in 2012. There were no adverse events noted. The results have been published in the Proceedings of the 9th World Association for Laser Therapy Congress (WALT) 2012.
Torpa II Study
A follow up study, called the TORPA II, analyzed the efficacy of PBM treatment for patients with dry AMD in 42 eyes. The TORPA II study demonstrated similar improvement in vision and contrast sensitivity in addition to reductions in drusen volume and central drusen thickness. This study extended the previous findings of improved functional outputs with positive efficacy in anatomical outcomes. These data were peer-reviewed and published (Merry et al., Acta Opthalmologica; 95, e270-e277; 2016).
LIGHTSITE I study
The LIGHTSITE I study conducted by LumiThera and using the Valeda Light Delivery System was conducted in Canada, with 30 subjects with Dry AMD.
This study investigated the efficacy and safety of PBM treatment in subjects with Dry AMD. Thirty subjects (46 eyes) were treated with the Valeda™ Light Delivery System, wherein subjects underwent two series of treatments (3× per week for 3-4 weeks) over 1 year. Outcome measures included best-corrected visual acuity, contrast sensitivity, microperimetry, central drusen volume and drusen thickness, and quality of life assessments. PBM-treated subjects showed a best-corrected visual acuity mean letter score gain of 4 letters immediately after each treatment series at Month 1 (M1) and Month 7 (M7). Approximately 50% of PBM-treated subjects showed improvement of ≥5 letters versus 13.6% in sham-treated subjects at M1. High responding subjects (≥5-letter improvement) in the PBM-treated group showed a gain of 8 letters after initial treatment (P < 0.01) and exhibited earlier stages of age-related macular degeneration disease. Statistically significant improvements in contrast sensitivity, central drusen volume, central drusen thickness, and quality of life were observed (P < 0.05). No device-related adverse events were reported. In conclusion, PBM treatment statistically improved clinical and anatomical outcomes with more robust benefits observed in subjects with earlier stages of dry age-related macular degeneration. Repeated PBM treatments may be necessary to maintain benefits. These pilot findings support previous reports and suggest the utility of PBM as a therapy in subjects with Dry AMD.
LIGHTSITE IIII clinical trial
The LIGHTSITE IIII clinical trial demonstrated positive effects of photobiomodulation, 55% of the subjects showed a 5 or more letters improvement following a 13 month clinical study.
PBM is NOT suitable for patients who have or have been treated for wet age-related macular degeneration, or those with epilepsy or light sensitivity.
