AMD PATEINTS ADD-ON TRIALS OF ANTIOXIDANTS

AMD Pateints Add-On Trials Of Antioxidants



Investigator Statement Of Approval

A Multi-center, Randomized Trial of Lutein, Zeaxanthin, and Omega-3 Long-Chain Polyunsaturated Fatty Acids (Docosahexaenoic Acid [DHA] and Eicosapentaenoic Acid [EPA]) in Age-Related Macular Degeneration I have read the Protocol and agree to follow the procedures as outlined in this Protocol. I will not start the study until I have obtained written approval by the governing Institutional Review Board/Ethics Committee. I will obtain written informed consent from all study participants prior to conducting any study procedures.

I understand that my electronic or handwritten signature, or that of a co- investigator, on a case report form indicates that the data contained on that form have been reviewed and accepted as accurate by the signatory. I understand that this protocol and related information is subject to the confidentiality terms found in my signed Confidentiality or Clinical Services Agreement. I agree to protect the confidentiality of my patients when allowing the Sponsor of this clinical trial and/or relevant regulatory authorities access to my medical records for AMD2 participants.

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Abstract

AMD2 is a multi-center Phase III randomized clinical trial designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 LCPUFAs as a treatment for AMD, cataract and moderate vision loss. In addition to this objective, the study will provide information on the clinical course, prognosis, and risk factors for development and progression of both AMD and cataract. Other study goals include the evaluation of eliminating beta-carotene and/or reducing zinc in the original AMD formulation on the progression and development of AMD. AMD2 will also seek to validate the fundus photographic AMD scale developed from AMD.

AMD Pateints Add-On Trials Of Antioxidants

Study Question

Evaluate the effect of dietary xanthophylls (lutein/zeaxanthin) and/or omega-3 LCPUFAs (DHA and EPA) on progression to advanced in Age-Related Macular Degeneration.

Introduction & Study Objectives

The primary objective of AMD2 is to evaluate the effect of dietary xanthophylls (lutein/zeaxanthin) and/or omega-3 LCPUFAs (DHA and EPA) on progression to advanced AMD. This objective will be accomplished by collecting and assessing the data on approximately 4,000 AMD2 participants aged 50 to 85 years, who at the time of enrollment, have sufficiently clear lenses for quality fundus photographs and have either: 1) bilateral large drusen or 2) large drusen in one eye and advanced AMD (neovascular AMD or central geographic atrophy) in the fellow eye. The objectives of AMD2 are to:

Study the effects of high supplemental doses of the dietary xanthophylls (lutein and zeaxanthin) and omega-3 LCPUFAs (DHA and EPA) on the development of advanced AMD.

Study the effects of these supplements on moderate vision loss (doubling of the visual angle or the loss of 15 or more letters on the ETDRS chart).

Study the effects of these supplements on cataract.

Study the effects of eliminating beta-carotene in the original AMD formulation on the development and progression of AMD.

Study the effects of reducing zinc in the original AMD formulation on the development and progression ...