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Pascale Benlian, Cecile Delcourt, Guiseppe Querques, Alain Zourdani, NAT-2 Study Group, Eric Souied; Oral DocosaHexaenoic Acid (DHA) In The Prevention of Exudative Age-Related Macular Degeneration: The NAT-2 Study. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6642.
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To evaluate the efficacy and safety of oral DHA in preventing the occurrence of choroidal neovascularization (CNV) in Age-related Macular Degeneration (AMD) over 3 years.
The NAT-2 (Nutritional AMD Treatment-2) study is a double-masked, single-centre, randomized, parallel, comparative trial in patients (pts) with early AMD (drusen, no CNV) in the study eye and neovascular AMD in the fellow eye, receiving oral DHA (840 mg/d) or Placebo (PBO, olive oil). Primary Study End Point (SEP): time to occurrence of CNV in the study eye. Secondary efficacy SEP in study eye are: percentage of subjects developing CNV, changes in visual acuity (VA) and function, occurrence and progression of drusen and DHA in red-blood-cell membranes (RBCM) .
Among 263 Caucasian AMD pts (Full Set Analysis, 134:DHA and 129:PBO), 170 (65%) were women; 24.3% had AMD family history and 77% were never-smokers. They were aged 71y at diagnosis and 74y at entry; mean BMI was 26. At baseline, mean BCVA was 0.13 LogMAR in the study eye, cataract was found in 162 (62%), ≥5 large drusen in 258 (98%), and at least 1 soft drusen or pigmentary changes in 205 (78%) pts. At 3-y follow-up, at least 78% pts were compliant as assessed by a median +88% increase in serum DHA, in the DHA-allocated group vs -7% (PBO). In the study eye, mean time to CNV occurrence was similar in both groups: 19.5mo (DHA) vs 18.7mo (PBO) over 3y. Yearly rate of CNV occurrence progressed similarly in both groups from 9% (1-y) to 13% (3-y), with an overall 27% event rate. At 3y, BCVA in the study eye was similar in both groups: 0.29 (DHA) vs 0.24 (PBO) LogMAR, with 18% (DHA) and 14% (PBO) showing >15 letters decrease at 3y. Number, size and type of drusen progressed similarly in DHA and PBO groups. A strong median DHA increase in RBCM was observed from baseline in the DHA group: +60% (DHA) vs +4% (PBO), p<0.001. In this elderly population, adverse events (AE) rate was related to advanced-age morbidity; most of the ocular AE were mainly a result of AMD and cataract progression in both eyes.
CNV progression was not reduced in patients with advanced AMD receiving oral DHA over 3y. Subgroup analysis may give more information about a potential role of DHA in prevention of exudative AMD.
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