Combination Therapy with Dietary Zeaxanthin for Neovascular Age Related Macular Degeneration. A Randomized Clinical Trial

Abstract

Purpose: A previous comparative interventional study suggested oral zeaxanthin added to triple therapy of intravitreal bevacizumab, intravitreal corticosteroids and photodynamic therapy with verteporfin for the treatment of neovascular age-related macular degeneration (NVAMD) was comparatively effective and cost-effective. A randomized clinical trial was undertaken to confirm these effects. Methodology: A two-year, triple-blinded, randomized clinical trial enrolled 144 participants (168 eyes) with NVAMD to triple therapy (TT) (intravitreal bevacizumab, reduced-fluence photodynamic therapy and intravitreal dexamethasone) or the same triple therapy with oral zeaxanthin (TTZ) supplementation, 20 mg daily. Data were modeled out to the 11-year life expectancy of the average participant. Results: At 24-months, twenty-seven percent (17/62) of TTZ eyes gained ≥ 15 letters, versus 9% (7/81) of TT eyes (p=0.003). Among unilateral, NVAMD participants, NVAMD developed in 23% (12/53) of TT and 6% (3/47) of TTZ fellow eyes with atrophic age-related macular degeneration (AMD) (p=0.02) by 24 months after baseline. The incremental costutility ratio of oral zeaxanthin supplementation was a remarkably low $30/QALY (quality-adjusted life-year). Zeaxanthin supplementation to TT is cost-effective in every country since the 11-year cost of TTZ ($14,486) exceeds the cost of TT ($14,480) by only $6, yet provides a 0.200 QALY gain. Conclusion: Oral zeaxanthin supplementation of triple therapy for the treatment of neovascular age-related macular degeneration is comparatively effective because it yields improved vision and reduces the incidence of subsequent neovascular age-related macular degeneration in fellow eyes with atrophic age-related macular degeneration by 74%. Oral zeaxanthin supplementation is very cost-effective in the U.S. and worldwide referent to most ophthalmic interventions.