LIGHTSITE I CLINICAL TRIAL
The LIGHTSITE I study is the first prospective, sham controlled, double-masked clinical study to evaluate the effectiveness of photobiomodulation (PBM) treatment in patients with dry age-related macular degeneration (AMD). The study included 46 eyes and subject participation lasted 12 months. Results from the LIGHTSITE I study showed clinical improvements in visual and anatomical outcome measures following multi-wavelength PBM. Improvements were observed in Best-Corrected Visual Acuity (BCVA) and Contrast Sensitivity (CS) in addition to improvements in pathological hallmarks such as Central Drusen Volume (CDV). These data provide a strong foundation for the utility of PBM therapy and demonstrate disease-modifying effects.
The PBM therapy (three treatments per week for three weeks) was most beneficial in dry AMD patients immediately following the completion of the treatment sessions highlighting a need for follow-up maintenance therapy. Retreatments at a six-month interval were performed to maintain clinical benefits.
No device-related adverse events were reported throughout the course of the study highlighting a favorable safety profile. The results demonstrate that the therapy is both a safe and effective treatment for early-stage dry AMD patients.
This foundational data will accelerate our learning to develop options to treat complicated degenerative eye diseases, where patient options are limited. The current trial results will be used to refine the upcoming multi-center clinical trials expected to start initially in Europe, and then in the US.
The 30-subject pilot study was partially funded from a Small Business Innovation Research (SBIR) grant awarded to the Company from the National Institute of Health and the National Eye Institute.
The LIGHTSITE II study was 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 (Europe). The study included 53 eyes (44 subjects) and participation lasted 10 months. The LIGHTSITE II study was underway when the COVID-19 viral outbreak occurred. This global public health emergency significantly impacted the conduct of the clinical trial and LumiThera decided to terminate new patient enrollment permanently and converted the study to a feasibility study. While COVID-19 had a significant interference on study design, improvement in visual outcomes in patients who completed all rounds of PBM treatment further supported the findings from the LIGHTSITE I study.
Study Publications: Burton, Ben et al. “LIGHTSITE II Randomized Multicenter Trial: Evaluation of Multiwavelength Photobiomodulation in Non-exudative Age-Related Macular Degeneration.” Ophthalmology and therapy vol. 12,2 (2023): 953-968. doi:10.1007/s40123-022-00640-6
Available from: https://pubmed.ncbi.nlm.nih.gov/36588113/
The LIGHTSITE III study evaluated the safety and efficacy of photobiomodulation (PBM) for the treatment of dry age-related macular degeneration (AMD). The study aimed to evaluate the long-term vision and anatomical benefits of PBM using the Valeda Light Delivery System in subjects with dry age-related macular degeneration (AMD).
Subjects were randomized into a 2:1 treatment groups. Each group received 3 treatments per week over 3-5 weeks every four months for a total of 24 months. The trial included 148 eyes (100 subjects) and participation lasted 24 months. LIGHTSITE III met the predetermined primary efficacy of BCVA with a statistically significant difference between PBM and Sham groups with a gain of 6.2 letters at Month 21 (p = 0.0036), which was maintained at Month 24 with a gain of 5.6 letters. At Month 21, approximately 61.5% of PBM-treated eyes showed a ≥ 5 letter gain (mean of 9.0 letters), 23.1% of PBM-treated eyes showed a ≥ 10 letter gain (mean of 12.8 letters), and 4.4% of PBM-treated eyes showed a ≥ 15 letter gain (mean of 15.5 letters). Incident geographic atrophy (GA) was reduced in the PBM compared to the Sham group at 24-months (p = 0.007; PBM, 6.8% vs. Sham, 24.0%). Although incident GA was not a pre-specified clinical endpoint, the results support overall safety benefits of treating earlier in dry AMD disease. A favorable safety profile was observed.
Valeda Light Delivery System User Manual. LumiThera, Inc.
The ELECTROLIGHT was an open label, prospective, pilot clinical study on PBM effect in subjects with Dry AMD. Electroretinography (ERG) is a quantitative and functional measure of visual output in the diagnosis and management of AMD. The Valeda Light Delivery System, and the Diopsys NOVA™ ERG device were used to investigate PBM effects on multiple parameters of visual function in dry AMD. 15 Dry AMD subjects (23 eyes) were treated with one series of PBM and followed for 6-months. ERG protocols included multi-focal (mf-ERG), and multi-luminance (ML-ERG). Significant improvements of visual output were observed over the 6-month time course. Subjects showed an improvement in ML-ERG that was additive across the 9 PBM treatment sessions. PBM improved ML-ERG magnitude by 14.4% at Month 1 with a reduction to near baseline (BL) levels at Month 3. A moderate improvement in ML-ERG was observed at Month 6. PBM-treated subjects showed consistent improvements in BCVA following PBM treatment and a sustained vision improvement at Month 6 (p < 0.001). An approximate 12 letter (BCVA) vision improvement at Month 1, 3 and 6 was observed (p <0.001). Significant improvement in contrast sensitivity and in the Amsler grid test were also observed. Valeda showed a positive safety profile with no signs of phototoxicity and a low rate of AEs. No ocular adverse events were observed following testing with the Diopsys ERG or seen following PBM intervention. Treatment with Valeda provided statistically significant improvements in BCVA, CS and ERG function following one series of PBM. These results strongly support further clinical testing of PBM as a non-invasive treatment for dry AMD patients and the utility of ERG as a functional indicator for changes in retinal output.
ClinicalTrials.gov Identifier: NCT04522999
Ongoing Clinical Trials
For information on the studies and their site locations can be found at www.clinicaltrials.gov.
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