Treatment of exudative age-related macular degeneration with aflibercept combined with pranoprofen eye drops or nutraceutical support with omega-3: A randomized trial

Br J Clin Pharmacol. 2019 May;85(5):908-913. doi: 10.1111/bcp.13871. Epub 2019 Feb 28.

Abstract

Aims: The aim of this study was to determine whether a combination of intravitreal aflibercept (IVA) and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization (CNV) in age-related macular degeneration.

Methods: This was a prospective, randomized, pilot study in 60 patients with treatment-naïve CNV. Patients were randomized 1:1:1 into three groups: aflibercept monotherapy (AM), aflibercept plus pranoprofen (AP) or aflibercept plus nutraceutical (AN) tablets containing multivitamin antioxidant and mineral supplementation plus omega-3.

Results: At 12 months, all groups showed significant improvement in both best-corrected visual acuity (BCVA) and central retinal thickness (CRT). The mean BCVA change from baseline to 12 months was -0.26 ± 0.06 LogMAR, -0.30 ± 0.06 LogMAR and -0.24 ± 0.04 LogMAR in the AM, AP and AN groups, respectively. The mean CRT change from baseline to 12 months was -76.9 ± 10.9 μm, -129 ± 19.9 μm and -105 ± 11.6 μm in the AM, AP and AN groups, respectively. The AN group required one less IVA injection than the AM group.

Conclusions: Compared with AM, both combination groups acted synergistically, although no significant benefits in BCVA were found over AM. Nutraceutical support with omega-3 leads to a reduced need for IVA.

Keywords: aflibercept; age-related macular degeneration; multivitamin antioxidant; omega-3; pranoprofen.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Aged
  • Aged, 80 and over
  • Benzopyrans / pharmacology*
  • Benzopyrans / therapeutic use
  • Dietary Supplements*
  • Drug Synergism
  • Drug Therapy, Combination / methods
  • Fatty Acids, Omega-3 / administration & dosage*
  • Female
  • Humans
  • Intravitreal Injections
  • Macular Degeneration / therapy*
  • Male
  • Middle Aged
  • Ophthalmic Solutions / administration & dosage
  • Pilot Projects
  • Propionates / pharmacology*
  • Propionates / therapeutic use
  • Prospective Studies
  • Receptors, Vascular Endothelial Growth Factor / therapeutic use
  • Recombinant Fusion Proteins / pharmacology*
  • Recombinant Fusion Proteins / therapeutic use
  • Tablets
  • Treatment Outcome
  • Vascular Endothelial Growth Factor A / antagonists & inhibitors
  • Vitamins / administration & dosage

Substances

  • Benzopyrans
  • Fatty Acids, Omega-3
  • Ophthalmic Solutions
  • Propionates
  • Recombinant Fusion Proteins
  • Tablets
  • VEGFA protein, human
  • Vascular Endothelial Growth Factor A
  • Vitamins
  • aflibercept
  • pyranoprofen
  • Receptors, Vascular Endothelial Growth Factor