Emerging Therapeutic Options in the Management of Age-Related Macular Degeneration

Abstract

Purpose: To assess the efficacy of two therapies, intravitreal aflibercept and oral saffron supplementation, for the treatment of different aspects of age-related macular degeneration (AMD). Methods: Two prospective clinical trials were conducted, i) one open label, single arm trial investigating intravitreal aflibercept for the management of treatment-resistant neovascular AMD, and ii) the other a randomised control trial investigating oral saffron supplementation for the treatment of intermediate AMD. Outcomes assessed included: mean change in mfERG response, mean change in individual mfERG ring response, mean change in BCVA and safety of saffron as compared to placebo. Results: i) The mean gain in BCVA was 6.7 and 4.7 letters at 6 and 12 months respectively (p<0.001), and the mean reduction in CMT was 100.0 µm at 6 and 12 months respectively. ii) Saffron supplementation was associated with a 2.1% increase in overall mfERG response (p=0.08) and a 0.69 letter increase in BCVA (p=0.001) compared to placebo. In those patients on AREDS supplements, saffron was associated with an increase of 2.8% in mfERG and an increase in BCVA of 0.73 letters (p<0.05 for both). There was no significant difference in adverse event frequency (overall or by subtype) whilst on saffron as compared to placebo. Conclusions: i) Intravitreal aflibercept was an effective therapy for the management of treatment-resistant neovascular AMD. The efficacy of aflibercept waned slightly over time, and further research is needed on the long-term effects of anti-VEGF agents. ii) Oral saffron was effective in improving visual outcomes in patients with intermediate AMD, including those on current standard of care therapy (AREDS supplement or equivalent), suggesting that oral saffron may offer additional benefit. Given the considerable burden that AMD imposes on sufferers and the health-care system in general, further consideration and research should be conducted into the role of saffron as therapy for AMD.