April 2009
Volume 50, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2009
Ranibizumab Dose Comparison in the Treatment of Diabetic Macular Edema
Author Affiliations & Notes
  • J. Jonisch
    Ophthalmology, North Shore-Long Island Jewish Health System, Great Neck, New York
  • P. J. Ferrone
    Ophthalmology, North Shore-Long Island Jewish Health System, Great Neck, New York
    Ophthalmology, Long-Island Vitreo-Retinal Consultants, Great Neck, New York
  • Footnotes
    Commercial Relationships  J. Jonisch, None; P.J. Ferrone, research grant, F.
  • Footnotes
    Support  Genentech
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 1347. doi:
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    • Get Citation

      J. Jonisch, P. J. Ferrone; Ranibizumab Dose Comparison in the Treatment of Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1347.

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

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Abstract

Purpose: : To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab and 1.0 mg of ranibizumab.

Methods: : Investigator sponsored prospective randomized single-blinded clinical trial. Eyes were randomized to one of two groups: 1.0 mg ranibizumab or 0.5 mg ranibizumab. Each patient received three monthly injections, followed by injections on an as needed re-treatment protocol.

Results: : A 6-month interim analysis included 31 eyes of 25 patients. The two groups did not differ significantly at baseline in average age, ETDRS letters, OCT central macular thickness, OCT macular volume, and blood pressure. The 1.0 mg group had a greater improvement of ETDRS vision when analyzed over the six month time period (p=0.03). The 1.0 mg group had an average gain of 8.92 ETDRS letters as compared with 3.50 letters gained in the 0.5 mg group (p=0.08). Mean decrease in central foveal thickness was 149.46 µm in the 1.0 mg group and 103.28 in the 0.5 mg group (p=0.22). Average number of injections in the 1.0 mg group was 3.85 as compared to 3.72 injections in the 0.5 mg group (p=0.55). There was no change in systolic or diastolic blood pressure in either group. No serious adverse events occurred on either group.

Clinical Trial: : www.clinicaltrials.gov NCT00440609

Keywords: diabetic retinopathy • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • vascular endothelial growth factor 
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