Study of Nutritional Supplementation in Patients With Unilateral Wet AMD

Summary

Retinal diseases are currently the leading cause of legal blindness in the developed world. Among these disorders, age-related macular degeneration (AMD) is one of the most prevalent conditions in individuals over 55 years of age. Late AMD, the most severe presentation of the disease, clinically manifests as either geographic atrophy (dry form) or choroidal neovascularization (CNV) (wet form). Although patients with wet AMD only represent 10% of the total cases, CNV is the main and most serious cause of central vision loss. At present, the treatment of wet AMD comprises intraocular injections of certain antiangiogenic agents which act by blocking VEGF (vascular endothelial growth factor). No effective treatment is yet available for dry AMD, though the AREDS (Age-Related Eye Disease Study) has shown that the administration of antioxidant supplements is able to slow progression of the disease. Such vitamin supplements are also indicated in patients who already have severe AMD (both exudative and atrophic) in one eye, since the risk of progression in these cases is high.

Recent studies involving new antioxidant and antiangiogenic molecules such as resveratrol, present in grapes and wine, have also revealed great efficacy in slowing the progression of advanced AMD. Hydroxytyrosol is another polyphenol with important antioxidant and antiinflammatory effects in the RPE.

Considering the above, the present randomized, multicenter interventional study involving Spanish and Portuguese patients with unilateral wet AMD was designed to compare the effects of two different nutritional supplements: one containing the antioxidants and minerals recommended by the AREDS at doses that can be used in the European Union (Theavit), and the other comprising these same substances plus omega-3 fatty acids (lipidic antioxidant), lutein (pigment protecting against light-induced damage) and resveratrol (antioxidant and antiangiogenic agent) (Retilut).

Conditions

• Wet Macular Degeneration

Interventions

DIETARY_SUPPLEMENT

Retilut

antioxidants, antiangiogenic, antiinflammatory micronutrients

DIETARY_SUPPLEMENT

Theavit

antioxidants micronutrients

Sponsors & Collaborators

• Alpha Bioresearch S.L.

  collaborator OTHER

• Investigación Estadística

  collaborator UNKNOWN

• Laboratorios Thea, Spain

  lead INDUSTRY

Principal Investigators

• Alfredo García-Layana, MD · Clínica Universidad de Navarra

• Roberto Gallego-Pinazo, MD · Hospital Universitario Politécnico La Fe

• Emiliano Hernández-Galilea, MD · University of Salamanca

• Miguel Ángel Zapata-Victori, MD · Hospital Universitario Vall d´Hebron

• Maximino Abraldes, MD, PhD · Complexo Hospitalario Universitario de Santiago de Compostela

• Rufino Silva, MD, PhD,FEBO · Association for Innovation and Biomedical Research on Light and Image

• Joao Nascimento, MD · Instituto de Retina e Diabetes Ocular de Lisboa

• Jose J Escobar-Barranco, MD · Hospital Dos de Maig

• Pilar Calvo, Md, PhD · Miguel Servet University Hospital, Zaragoza

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2018-04-30

Completion

2018-04-30

Countries

• Portugal
• Spain

Study Locations