June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
Vitamin B Intervention in Non-Proliferative Diabetic Retinopathy
Author Affiliations & Notes
  • Michael Smolek
    CLEVER Eye Institute, Slidell, LA
    Louisiana Eye Research Institute, Slidell, LA
  • Neil Notaroberto
    CLEVER Eye Institute, Slidell, LA
    EyeCare 20/20, Slidell, LA
  • Lisa Pradillo
    CLEVER Eye Institute, Slidell, LA
    EyeCare 20/20, Slidell, LA
  • Arley Jaramillo
    CLEVER Eye Institute, Slidell, LA
    EyeCare 20/20, Slidell, LA
  • Kaci Lee
    CLEVER Eye Institute, Slidell, LA
    EyeCare 20/20, Slidell, LA
  • Footnotes
    Commercial Relationships Michael Smolek, Pamlab, LLC (F); Neil Notaroberto, Centervue (S), Ellex (S); Lisa Pradillo, None; Arley Jaramillo, None; Kaci Lee, None
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 217. doi:https://doi.org/
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    • Get Citation

      Michael Smolek, Neil Notaroberto, Lisa Pradillo, Arley Jaramillo, Kaci Lee; Vitamin B Intervention in Non-Proliferative Diabetic Retinopathy. Invest. Ophthalmol. Vis. Sci. 2013;54(15):217. doi: https://doi.org/.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: A pilot study was conducted to determine whether biologically active vitamin B intervention is effective in reducing the signs or symptoms of nonproliferative diabetic retinopathy (NPDR) in type 2 diabetes mellitus patients. Vitamin B mediates homocysteine levels and contributes to the production of nitric oxide, both of which play a critical role in vascular repair and maintenance.

Methods: An open-label, one-arm, uncontrolled, prospective study was conducted on 10 NPDR patients newly prescribed with Metanx®, which is currently used for controlling the symptoms of diabetic peripheral neuropathy. A standard daily dose of Metanx is two tablets. Each tablet contains: 3 mg L-methylfolate Calcium (vitamin B9 as Metafolin® - Merck KGaA, Darmstadt, Germany); 35 mg Pyridoxal-5′-Phosphate (vitamin B6); and 2 mg Methylcobalamin (vitamin B12). Two main outcome objectives were followed: change in mean retinal threshold sensitivity measured by microperimetry (MAIA®, CenterVue, Padova, Italy) and change in mean central retinal thickness measured by spectral domain OCT (Spectralis®, Heidelberg Engineering, Carlsbad, CA, USA). Subjects were prescribed with Metanx at the month-0 baseline examination and seen once per month for 6 months. All subjects gave informed consent.

Results: Three subjects were lost to follow-up. Of the remaining 7 subjects, 2 of 14 eyes had significant foveal edema and MAIA testing was unreliable due to poor fixation. The remaining 12 eyes exhibited significant improvement at 3 months for threshold sensitivity (p<0.001) and significant improvement in retinal thickness at 6 months (p=0.012). The trend for improvement for retinal sensitivity was non-linear and reached a plateau by month 3. The decrease in retinal thickness over time had a linear trend that was significant (R2=0.625; p=0.034).

Conclusions: Biologically active vitamin B appears to have a significant effect on NPDR. Further research is needed to determine whether this trend continues with time, and whether the efficacy can be adjusted by the dosage. More critically, a placebo-controlled study needs to be performed to rule out any potential bias in the results.

Keywords: 499 diabetic retinopathy • 618 nutritional factors • 617 nitric oxide  
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