Intervention with vitamins in patients with nonproliferative diabetic retinopathy: a pilot study

Abstract

Michael K Smolek,1 Neil F Notaroberto,1,2 Arley G Jaramillo,1,2 Lisa R Pradillo1,2 1CLEVER Eye Institute, 2EyeCare 20/20, Slidell, LA, USA Background: The purpose of this study was to determine whether a combination of vitamins B6, B9, and B12 is an effective intervention for reducing the signs and symptoms of nonproliferative diabetic retinopathy. Methods: Ten subjects with type 2 diabetes mellitus (n = 20 eyes) with clinically diagnosed mild to moderate nonproliferative diabetic retinopathy were recruited from a private practice ophthalmology clinic for this open-label, uncontrolled, prospective six-month study. Metanx® vitamin tablets (containing 3 mg L-methylfolate calcium, 35 mg pyridoxal-5′-phosphate, and 2 mg methylcobalamin) were administered at a dosage of two tablets daily. Primary outcome indicators were the percent change in mean retinal sensitivity threshold measured by macular microperimetry and the percent change in mean central retinal thickness measured by spectral-domain optical coherence tomography. Results: Three subjects were lost to follow-up. In the remaining seven subjects, two of 14 eyes had foveal edema that prevented microperimetry measurements due to poor fixation. The remaining 12 eyes showed a nonlinear improvement in mean threshold retinal sensitivity (P < 0.001). Overall change in mean central retinal thickness in 14 eyes was linear (R2 = 0.625; P = 0.034), with a significant reduction between one and six months (P = 0.012). Conclusion: In this pilot study, the Metanx intervention appeared to have some beneficial effects with respect to reducing retinal edema and increasing light sensitivity in subjects with nonproliferative diabetic retinopathy. Keywords: diabetes, diabetic retinopathy, vitamin B, homocysteine, nitric oxide, microperimetry