04.04.18
Oral zeaxanthin supplementation of triple combination therapy for the treatment of neovascular age-related macular degeneration (NVAMD) is comparatively effective and cost-effective to triple therapy alone according to a study published in the Journal of Clinical and Experimental Ophthalmology. Findings from the randomized, 24-month clinical trial also suggest that the addition of oral zeaxanthin further improves vision and reduces the incidence of subsequent NVAMD in fellow eyes as well as the number of treatment cycles required.
Age-related macular degeneration (AMD), primarily NVAMD, is the leading cause of legal blindness in the U.S. (Bressler NM. JAMA, 2004). While there is as yet no outright cure for AMD, multiple NVAMD treatment modalities exist that may delay its progression or even improve vision. The mainstay of NVAMD therapy at the current time is monotherapy with intravitreal vascular endothelial growth factor (VEGF) inhibitor injections. Studies have also evaluated NVAMD triple therapy, specifically Photodynamic therapy with verteporfin (PDT), and intravitreal VEGF-inhibitor and corticosteroid therapy.
A previous comparative, non-randomized study and cost-effective analysis published in 2015 in the International Journal of Retina and Vitreous evaluated the efficacy of triple combination therapy with and without oral zeaxanthin, as well as the economic viability of the therapies. Researchers reported that NVAMD triple therapy is comparatively effective and cost-effective and requires considerably less treatment than needed with monotherapy, and that adding oral zeaxanthin appears to further reduce the treatment cycles required, and possibly reduce fellow eye choroidal neovascularization development.
To further assess the benefit of triple therapy (TT) versus triple therapy with oral zeaxanthin supplementation (TTZ), this new two-year, randomized clinical trial was conducted to evaluate the preference-based comparative effectiveness and incremental cost-effectiveness of zeaxanthin supplementation for NVAMD triple therapy.
A total of 144 participants, ages 52-94 (79-year mean) with NVAMD participated in the double-blind study. Participants received either triple therapy (intravitreal bevacizumab, reduced-fluence photodynamic therapy and intravitreal dexamethasone) or the same triple therapy with 20-mg daily of oral zeaxanthin (EyePromise Zeaxanthin, ZeaVision)supplementation.
Following a baseline evaluation, participants were re-examined at 4-6 weeks. If stable, follow-up was undertaken every 6-8 weeks in year one and 8-12 weeks in year two. Retreatment was based on residual/recurrent subretinal blood, subRPE/subretinal/intraretinal fluid, decreased vision, IVFA leakage, or an ICG angiographic occult plaque. Triple therapy was repeated when retreatment was given.
Twenty-seven percent of TTZ Cohort eyes gained ≥ 15 letters (≥ 3-line vision gain) at 24 months, versus 9% in the TT Cohort (p=0.006). A 24-month loss of ≥ 15 letters was observed in 10% of TTZ Cohort eyes and 10% of TT Cohort eyes (p=0.97). Stable (≤ 5 letter loss) or improved vision at 24 months was noted in 76% (47/62) of TTZ Cohort eyes and 77% of TT Cohort eyes (p=0.92).
“This clinical trial confirms that triple therapy supplementation with oral zeaxanthin yields a visual result superior to triple therapy alone,” says Joseph Olk, MD, principal investigator and partner at The Retina Center of St. Louis. “Adding oral zeaxanthin also appears to further reduce the number of treatment cycles required. Triple therapy was required a mean of 2.9 times over two-years, while triple therapy with zeaxanthin supplementation was administered a mean of 2.4 times,” he adds.
Researchers also saw a reduction in the percentage of fellow eyes with atrophic AMD progressing to neovascular AMD over the 24-months of the trial. “Supplementation with oral zeaxanthin appeared to reduce the development of fellow eye NVAMD by 74%,” noted Dr. Olk. The two-year conversion rate was 23% in the triple therapy cohort and 6 percent in the triple therapy with zeaxanthin cohort. Conversion rates in the earlier non-randomized trial were 12.5% and 6.25%, respectively (p=0.03).
Zeaxanthin supplementation in the randomized clinical trial was remarkably cost-effective at $30/QALY (quality-adjusted life-year). While there are no formal cost-effectiveness standards in the U.S., many researchers consider an intervention costing less than $100,000/QALY to be cost-effective. “By World Health Organization cost-effectiveness standards oral zeaxanthin appears to be cost-effective for use with NVAMD in virtually every country globally,” notes Melissa Brown, MD, MN, MBA, CEO of the Center for Value-Based Medicine, a healthcare economic research organization.
The study was supported in part by unrestricted grants from ZeaVision, Inc. to The Retina Center of St. Louis County and the Center for Value-Based Medicine. The sponsor played no role in performing the trial, analyzing the results or altering the manuscript.
Age-related macular degeneration (AMD), primarily NVAMD, is the leading cause of legal blindness in the U.S. (Bressler NM. JAMA, 2004). While there is as yet no outright cure for AMD, multiple NVAMD treatment modalities exist that may delay its progression or even improve vision. The mainstay of NVAMD therapy at the current time is monotherapy with intravitreal vascular endothelial growth factor (VEGF) inhibitor injections. Studies have also evaluated NVAMD triple therapy, specifically Photodynamic therapy with verteporfin (PDT), and intravitreal VEGF-inhibitor and corticosteroid therapy.
A previous comparative, non-randomized study and cost-effective analysis published in 2015 in the International Journal of Retina and Vitreous evaluated the efficacy of triple combination therapy with and without oral zeaxanthin, as well as the economic viability of the therapies. Researchers reported that NVAMD triple therapy is comparatively effective and cost-effective and requires considerably less treatment than needed with monotherapy, and that adding oral zeaxanthin appears to further reduce the treatment cycles required, and possibly reduce fellow eye choroidal neovascularization development.
To further assess the benefit of triple therapy (TT) versus triple therapy with oral zeaxanthin supplementation (TTZ), this new two-year, randomized clinical trial was conducted to evaluate the preference-based comparative effectiveness and incremental cost-effectiveness of zeaxanthin supplementation for NVAMD triple therapy.
A total of 144 participants, ages 52-94 (79-year mean) with NVAMD participated in the double-blind study. Participants received either triple therapy (intravitreal bevacizumab, reduced-fluence photodynamic therapy and intravitreal dexamethasone) or the same triple therapy with 20-mg daily of oral zeaxanthin (EyePromise Zeaxanthin, ZeaVision)supplementation.
Following a baseline evaluation, participants were re-examined at 4-6 weeks. If stable, follow-up was undertaken every 6-8 weeks in year one and 8-12 weeks in year two. Retreatment was based on residual/recurrent subretinal blood, subRPE/subretinal/intraretinal fluid, decreased vision, IVFA leakage, or an ICG angiographic occult plaque. Triple therapy was repeated when retreatment was given.
Twenty-seven percent of TTZ Cohort eyes gained ≥ 15 letters (≥ 3-line vision gain) at 24 months, versus 9% in the TT Cohort (p=0.006). A 24-month loss of ≥ 15 letters was observed in 10% of TTZ Cohort eyes and 10% of TT Cohort eyes (p=0.97). Stable (≤ 5 letter loss) or improved vision at 24 months was noted in 76% (47/62) of TTZ Cohort eyes and 77% of TT Cohort eyes (p=0.92).
“This clinical trial confirms that triple therapy supplementation with oral zeaxanthin yields a visual result superior to triple therapy alone,” says Joseph Olk, MD, principal investigator and partner at The Retina Center of St. Louis. “Adding oral zeaxanthin also appears to further reduce the number of treatment cycles required. Triple therapy was required a mean of 2.9 times over two-years, while triple therapy with zeaxanthin supplementation was administered a mean of 2.4 times,” he adds.
Researchers also saw a reduction in the percentage of fellow eyes with atrophic AMD progressing to neovascular AMD over the 24-months of the trial. “Supplementation with oral zeaxanthin appeared to reduce the development of fellow eye NVAMD by 74%,” noted Dr. Olk. The two-year conversion rate was 23% in the triple therapy cohort and 6 percent in the triple therapy with zeaxanthin cohort. Conversion rates in the earlier non-randomized trial were 12.5% and 6.25%, respectively (p=0.03).
Zeaxanthin supplementation in the randomized clinical trial was remarkably cost-effective at $30/QALY (quality-adjusted life-year). While there are no formal cost-effectiveness standards in the U.S., many researchers consider an intervention costing less than $100,000/QALY to be cost-effective. “By World Health Organization cost-effectiveness standards oral zeaxanthin appears to be cost-effective for use with NVAMD in virtually every country globally,” notes Melissa Brown, MD, MN, MBA, CEO of the Center for Value-Based Medicine, a healthcare economic research organization.
The study was supported in part by unrestricted grants from ZeaVision, Inc. to The Retina Center of St. Louis County and the Center for Value-Based Medicine. The sponsor played no role in performing the trial, analyzing the results or altering the manuscript.
