Post Marketing Surveillance to compare the efficacy and safety for the combination of Vitamin C Vitamin E Lutein Zeaxanthin Zinc and copper with the combination of Astraxanthin Glutathiione and Lutein in the patients of Age related macular degeneration AMD

Abstract

This study was conducted to compare efficacy and safety of AREDS 2 formula, the combination of Vitamin C, Vitamin E, Lutein, Zeaxanthin, Zinc and Copper with the combination of Astaxanthin, L-Glutathione and Lutein (contains Zeaxanthin) in the patients of AMD of type dry AMD and GA. This was an academic, prospective, open labelled, parallel, multicentric, comparative post marketing surveillance study. It was conducted at 5 clinical trial sites located in Mumbai, Maharashtra. All the recruited Investigators were of ophthalmology speciality. The clinical trial was conducted in compliance with the guidelines titled, New Drugs and Clinical Trial Rules 2019 and ICMR guidelines titled, National Ethical Guidelines for Biomedical and Health Research Involving Human Participants . newlineTotal 350 subjects were recruited at 5 clinical trial sites. At each clinical trial site 70 subjects were recruited. All subjects were randomized by investigators to take either Investigational product 1 which was fixed dose combination of Vitamin C 250 mg, Zinc 40 mg, Lutein 5 mg, Zeaxanthin 1 mg, Copper 1 mg and Vitamin E 200 IU per capsule or Investigational Product 2 which was fixed dose combination of Astaxanthin 6 mg, L-Glutathione 5 mg and Lutein (containing Zeaxanthin 256 mcg) 3.2 mg per tablet. Out of 70 subjects recruited at each clinical trial site, 35 subjects were randomized to Investigational Product 1 whereas the remaining 35 subjects randomized to Investigational Product 2. Out of 35 subjects randomized to each investigational product at each clinical trial site, 20 subjects were recruited with confirmed diagnosis of dry AMD with drusen characteristics associated with high risk of progression to exudative AMD including soft type drusen, more than 5 drusen, drusen size greater than 63 and#956;m, confluence of drusen (and#8805; 1) and RPE hyperpigmentation. The remaining 15 subjects at each site randomized to each investigational product, were recruited as per the special provision including subjects with non-foveal GA with non-advanced AMD or