LUM0001
Research type
Research Study
Full 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)
IRAS ID
254392
Contact name
Cindy Croissant
Contact email
Sponsor organisation
Lumithera, Inc.
Duration of Study in the UK
1 years, 3 months, 30 days
Research summary
Summary of Research
As the population continues to age, degenerative ocular diseases become increasingly common and create tremendous burden on the health care system.
AMD occurs in two forms: dry and wet AMD. The “dry” form of advanced AMD, results from atrophy of the retinal pigment epithelial (RPE) cell layer, which results in vision loss secondary to the death of photoreceptors (rods and cones) in the macula or central part of the eye. The “wet” form of advanced AMD, causes vision loss due to abnormal blood vessel growth, ultimately leading to blood and protein leakage below the macula. Bleeding, leaking, and scarring from these blood vessels eventually causes irreversible damage to the photoreceptors and rapid vision loss if left untreated.
The Valeda™ Light Delivery System is a multi-wavelength device designed for eye care professionals to use in the treatment of the eye with photobiomodulation (PBM). For randomised clinical studies, the Valeda™ Light Delivery System operates in one of two modes: PBM mode and sham mode. The apparent behaviour of the Valeda™ is identical for both treatment modalities. The two treatment modes differ only with respect to LED emissions.
This clinical study will further support the scientific basis for the utility of PBM treatment in patients with Dry AMD. While current research findings show the efficacy of PBM in a variety of clinical indications, there are few reports in patients with AMD and other ocular disease states. Positive findings from the proposed study will provide additional justification for PBM use and aid in the development of a novel treatment modality for patients with dry AMD.Summary of Results
Photobiomodulation (PBM) represents a potential treatment for non-exudative age-related macular degeneration (AMD). PBM uses light wavelengths to target components of the mitochondrial respiratory chain to improve cellular bioenergetic outputs. The multicenter LIGHTSITE II study was a randomized clinical trial evaluating safety and efficacy of PBM in intermediate non-exudative AMD. The LumiThera Valeda® Light Delivery System delivered multiwavelength PBM (590, 660 and 850 nm) or Sham treatment 3x per week over 3-4 weeks (9 treatments per series) with repeated treatments at baseline (BL), 4, and 8 months. Subjects were enrolled with 20/32 to 20/100 best-corrected visual acuity (BCVA) and no central geographic atrophy (GA) within the central fovea (500 μm). LIGHTSITE II enrolled 44 non-exudative AMD subjects including 53 eyes. PBM-treated eyes showed statistically significant improvement in BCVA at 9 months (n=51 eyes, p=0.02) with a 4-letter gain in the PBM-treated group versus 0.5 letter gain in the sham-treated group (p < 0.1) for patients that received all 27 PBM treatments (n=29 eyes). Approximately 35.3% of PBM-treated eyes showed >5 letters improvement at 9 months. Macular drusen volume was not increased overtime in the PBM-treated group but did show increases in the Sham-treated group. Whilst PBM and Sham groups both showed GA lesion growth in the trial period, there was 20% less growth in PBM vs Sham-treated subjects over 10 months, suggesting potential disease-modifying effects. No safety concerns or signs of phototoxicity were observed. These results confirm previous clinical testing of multiwavelength PBM and support its use as a novel treatment for non-exudative AMD.
REC name
HSC REC A
REC reference
18/NI/0188
Date of REC Opinion
9 Oct 2018
REC opinion
Favourable Opinion