Oral docosahexaenoic acid in the prevention of exudative age-related macular degeneration: the Nutritional AMD Treatment 2 study
Souied EH, Delcourt C, Querques G, Bassols A, Merle B, Zourdani A, Smith T, Benlian P, Nutritional AMD Treatment 2 Study Group
Ophthalmology · 116 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Assistance publique-Hôpitaux de Paris
Según 1 financiador declarado.
Publicación
- Publicado
- 2013-02-08 · Ophthalmology · vol. 120 · número 8 · págs. 1619–1631
- Editorial
- Elsevier BV
- Citado
- 160 citas · más que el 98% de estudios similares · 9.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 51 trabajos
- Acceso
- Acceso abierto (copia en repositorio) · CC-BY
- Áreas de investigación
- Retinal Diseases and Treatments · Fatty Acid Research and Health · Retinal Imaging and Analysis
- Palabras clave
- docosahexaenoic acid, omega-3 fatty acids, eicosapentaenoic acid, fish oil supplementation, neovascular age-related macular degeneration, choroidal neovascularization, age-related maculopathy, drusen, visual acuity, geographic atrophy
- MeSH
- humans, retinal drusen, vitamin e, lipids, docosahexaenoic acids, eicosapentaenoic acid, capsules, drug combinations, fluorescein angiography, administration, oral, prospective studies, double-blind method, visual acuity, dietary supplements, aged, aged, 80 and over, middle aged, female, male, wet macular degeneration
8 autores
- Eric H. Souied🇫🇷 · autor de correspondenciaUniversité Paris-Est Créteil; Hôpital Intercommunal de Créteil
- Cécile Delcourt🇫🇷Université de Bordeaux; Inserm
- Giuseppe Querques🇫🇷Université Paris-Est Créteil; Hôpital Intercommunal de Créteil
- Ana Bassols
- Bénédicte M. J. Merle🇫🇷Université de Bordeaux; Inserm
- Alain Zourdani🇫🇷Université Paris-Est Créteil; Hôpital Intercommunal de Créteil
- Theodore Smith🇺🇸NYU Langone Health; New York University
- Pascale Benlian🇫🇷 · autor de correspondenciaUniversité de Lille; Hôpital Saint-Antoine
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
To evaluate the efficacy of docosahexaenoic acid (DHA)-enriched oral supplementation in preventing exudative age-related macular degeneration (AMD).
Design
The Nutritional AMD Treatment 2 study was a randomized, placebo-controlled, double-blind, parallel, comparative study.
Participants
Two hundred sixty-three patients 55 years of age or older and younger than 85 years with early lesions of age-related maculopathy and visual acuity better than 0.4 logarithm of minimum angle of resolution units in the study eye and neovascular AMD in the fellow eye.
Methods
Patients were assigned randomly to receive either 840 mg/day DHA and 270 mg/day eicosapentaenoic acid (EPA) from fish oil capsules or the placebo (olive oil capsules) for 3 years.
Main outcome measures
The primary outcome measure was time to occurrence of choroidal neovascularization (CNV) in the study eye. Secondary outcome measures in the study eye were: incidence of CNV developing in patients, changes in visual acuity, occurrence and progression of drusen, and changes in EPA plus DHA level in red blood cell membrane (RBCM).
Results
Time to occurrence and incidence of CNV in the study eye were not significantly different between the DHA group (19.5±10.9 months and 28.4%, respectively) and the placebo group (18.7±10.6 months and 25.6%, respectively). In the DHA group, EPA plus DHA levels increased significantly in RBCM (+70%; P<0.001), suggesting that DHA easily penetrated cells, but this occurred unexpectedly also in the placebo group (+9%; P = 0.007). In the DHA-allocated group, patients steadily achieving the highest tertile of EPA plus DHA levels in RBCM had significantly lower risk (-68%; P = 0.047; hazard ratio, 0.32; 95% confidence interval, 0.10-0.99) of CNV developing over 3 years. No marked changes from baseline in best-corrected visual acuity, drusen progression, or geographic atrophy in the study eye were observed throughout the study in either group.
Conclusions
In patients with unilateral exudative AMD, 3 years of oral DHA-enriched supplementation had the same effect on CNV incidence in the second eye as did the placebo. However, RBCM fatty acid measurements revealed that CNV incidence was significantly reduced in DHA-supplemented patients showing a steadily high EPA plus DHA index over 3 years.
Financial disclosure(s)
Proprietary or commercial disclosure may be found after the references.
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