AMD is the leading cause of vision loss in people over the age of age 60. In AMD the vision usually degrades with time, highlighting the need for interventions to arrest or slow this process. As there are no effective orally-administered pharma drugs for that condition, herbs and dietary supplements can fill this void.
For efficacy evaluation, subjective symptoms/primary endpoint parameters such as difficulty in day vision, diminished vision, distorted vision, perception of black spots, dark adaptation, perception of flashes of light, and perception of objects as yellowish were assessed. Objective symptoms/secondary endpoint parameters, namely visual acuity to determine the improvement in distant vision and pinhole vision, improvement in the fundus changes, optical coherence tomography (OCT) changes, Amsler's grid aberration changes, and improvement in the visual field by using Humphrey visual field examination, were also evaluated.
“The maintenance of AMD symptoms from further deterioration is of paramount importance,” commented Sabinsa Founder and Chairman Dr. Muhammed Majeed. “Nutritional supplementation seems to hold great promise in that area. We are happy with the trial outcome, and look forward to continuing investigations.”
Abstract : Age-related macular degeneration (AMD) is one of the most widespread degenerative disorders in elderly people. A 90-day, open-label clinical study was conducted in 40 patients, aged 50 years or older, with early-stage dry-type AMD to evaluate the safety and efficacy of Macumax®, a novel mixture of a phyto-mineral nutritional supplement containing ZeaLutein® (consisting of lutein, zeaxanthin, and piperine), extracts of bilberry, saffron, and zinc monomethionine. Subjects received one capsule of the supplement twice daily for 90 days. The treatment measures included physical examination, vital signs, and assessment of subjective and objective symptoms at baseline and after treatment. For efficacy assessment, baseline values were compared with the values after treatment at 30-day intervals, on days 30, 60, and 90. The safety of the treatment was assessed during all the visits. Overall, the patients showed improvement in the subjective symptoms, such as vision scores after treatment compared with baseline. The changes in diminished and distorted vision scores were found to be significant from day 60 (P  max  .05). In the case of objective symptoms, only 40% of the subjects (P  max  .05) had abnormal Amsler's grid aberration scores on day 90 compared with 77.5% of subjects at the beginning of the study. No adverse events were observed during the study. This pilot study provides evidence that Macumax® supplementation is safe and maintained eye health without further progression of the disease in patients with early-stage dry-type AMD
Discussion : Regarding clinical efficacy, Macumax® treatment showed improvements in difficulty in day vision scores, perception of black spots, and improvement in dark adaptation compared with baseline. There were significant improvements in the diminished and distorted vision scores, respectively (P  max  .05). Similarly, improvements were also observed with secondary efficacy endpoints, namely in distant vision measures with Snellen visual acuity, pinhole vision, fundus changes, and in OCT. There was a significant change in Amsler's Grid test, which confirms a gradual improvement in the pathological condition. The percentage improvement in Amsler's Grid test was found to be 25% on day 30 and 60% on days 60 and 90 after the treatment. The change is found to be significant as confirmed from a distorted vision, which was assessed with the use of Amsler's grid (P  max  .05). Thus, the results of this trial confirm that the use of the study supplement preserves the eye condition without further deterioration and it can be concluded that with long usage it will prevent or delay the vision loss that has been observed if AMD is not treated. Out of 40 subjects, none of the subjects reported any AEs during the entire study period.
In conclusion, the findings provide clinical evidence that a 90-day oral supplementation of Macumax® was safe and helpful in preventing early-stage dry-type AMD without further progression of the disease.
An Open-Label Pilot Study on Macumax Supplementation for Dry-Type Age-Related Macular Degeneration, Muhammed Majeed, Shaheen Majeed, and Kalyanam Nagabhushanam, Journal of Medicinal Food, 27 Aug 2020

Abstract : Lutein, zeaxanthin, and meso-zeaxanthin are the only carotenoids found in the human macula and may have a role in visual function. These carotenoids are reported to protect the retina, and thus vision, as antioxidants and by acting as a blue light filter. Our objective was to determine a minimum concentration of lutein/zeaxanthin intake that is associated with a statistically significant and/or clinically important change in macular pigment optical density (MPOD) among adults with healthy eyes. We searched Ovid MEDLINE, CENTRAL, and the Commonwealth of Agriculture Bureau for English-language studies through to July 2020. Two reviewers screened results to identify studies that evaluated supplements or dietary sources of lutein/zeaxanthin on MPOD among adults with healthy eyes. One reviewer extracted data and assessed strength of evidence, which was confirmed by a second reviewer. Two independent reviewers assessed the risk of bias. Meta-analyses were stratified by total lutein/zeaxanthin dose. We included 46 studies (N = 3189 participants; mean age = 43 y; 42% male). There was no statistically significant change in MPOD among studies evaluating max 5 mg/d of total lutein/zeaxanthin intake which primarily assessed dietary interventions for 3-6 mo (pooled mean difference, 0.02; 95% CI: -0.01 to 0.05). The pooled mean increase in MPOD was 0.04 units (95% CI: 0.02 to 0.07) among studies evaluating 5 to max 20 mg/d of lutein/zeaxanthin and was 0.11 units (95% CI: 0.06 to 0.16) among studies evaluating min 20 mg/d of lutein/zeaxanthin for 3-12 mo. MPOD increased with lutein/zeaxanthin intake, particularly at higher doses, among adults with healthy eyes. The effects of lutein/zeaxanthin intake at doses max 5 mg/d or from dietary sources is less clear. Increased lutein/zeaxanthin intake can help with maintaining ocular health. Future research is needed to determine the minimum dose and duration of lutein/zeaxanthin intake that is associated with a clinically important change in MPOD or visual function.
Keywords: lutein; macular pigment optical density; meso-zeaxanthin; meta-analysis; systematic review; zeaxanthin
The Effect of Lutein/Zeaxanthin Intake on Human Macular Pigment Optical Density: A Systematic Review and Meta-Analysis, Lisa M Wilson, Saraniya Tharmarajah, Yuanxi Jia, Richard D Semba, Debra A Schaumberg, Karen A Robinson, Adv Nutr 2021 Jun 22