Clinical Trials Detalhe

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).

Wet Macular Degeneration

Inclusion Criteria: 1. Men or women aged ≥ 50 years. 2. Presence of unilateral choroidal neovascularisation or any of its clinical manifestations, such as disciform scars, subretinal hemorrhage, retinal pigment epithelium detachment associated to subretinal fluid and/or subretinal hemorrhage (stage V of the modified AREDS classification; AREDS, J.M. Seddon; IOVS 2009). 3. Patients who understand the conditions and particularities of the study and have given their written informed consent to participation in the trial. Exclusion Criteria: 1. Patients with myopia \> 6 dioptres. 2. Presence of posterior pole anomalies which can give rise to choroidal neovascularisation: nevi, angioid streaks, central serous choroidopathy, heredodegenerative retinal diseases, myopic choroidosis, diabetic retinopathy and choroiditis. 3. Media opacification precluding adequate assessment of the ocular fundus. 4. Patients who in the opinion of the investigator are very likely to not be able or not want to continue participating in the study. 5. Women of child-bearing potential who do not use a medically acceptable and highly effective contraceptive method (i.e., hormone implants, oral or parenteral contraceptives, together with condoms, certain intrauterine devices) from the inclusion visit and throughout the study treatment periods, up until two weeks after the study. Postmenopausal women (two years without menstruation) require no contraceptive method. 6. Patients having participated in any other treatment efficacy protocol in the previous three months. 7. Patients who will be participating in any other treatment efficacy protocol concomitant to the present study. 8. Patients using any type of nutritional supplement in the month before the screening visit. 9. Suspected or confirmed illegal drug abuse. 10. Incapacity of the patient and/or relatives to understand the study procedures, and thus inability to give informed consent. 11. Non-compliers, i.e., patients who fail to report to the follow-up visits or whose life style interferes with the protocol. 12. Patients under legal custody.