December 2002
Volume 43, Issue 13
ARVO Annual Meeting Abstract  |   December 2002
Effect of Intravitreous Hyaluronidase (Vitrase®) on Progression of Diabetic Retinopathy in Humans
Author Affiliations & Notes
  • BD Kuppermann
    Department of Ophthalmology University of CA-Irvine Irvine CA
  • H Quiroz Mercado
    La Ceguera Hospital Mexico City Mexico
  • F Graue-Wiechers
    Conde de Valenciana Mexico City Mexico
  • EL Thomas
    Retina-Vitreous Associates Los Angeles CA
  • PN Calvillo
    ISTA Pharmaceuticals Inc Irvine CA
  • LR Grillone
    ISTA Pharmaceuticals Inc Irvine CA
  • Footnotes
    Commercial Relationships    B.D. Kuppermann, ISTA Pharmaceuticals, Inc. F, C; H. Quiroz Mercado, ISTA Pharmaceuticals F; F. Graue-Wiechers, ISTA Pharmaceuticals, Inc. F; E.L. Thomas, ISTA Pharmaceuticals, Inc. F, C; P.N. Calvillo, ISTA Pharmaceuticals, Inc. E; L.R. Grillone, ISTA Pharmaceuticals, Inc. E.
Investigative Ophthalmology & Visual Science December 2002, Vol.43, 3865. doi:
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      BD Kuppermann, H Quiroz Mercado, F Graue-Wiechers, EL Thomas, PN Calvillo, LR Grillone; Effect of Intravitreous Hyaluronidase (Vitrase®) on Progression of Diabetic Retinopathy in Humans . Invest. Ophthalmol. Vis. Sci. 2002;43(13):3865.

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

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Abstract: : Purpose: To determine the effect of intravitreous Vitrase in eyes with and without induced posterior vitreous detachment (PVD) on the progression of moderately severe to severe non-proliferative diabetic retinopathy (NPDR). Methods: Patients were evaluated by ultrasonography and fundus photography in a masked pilot study. Sixty patients were randomly assigned to one of four treatment groups. A single intravitreous injection was given to one eye of each patient as follows: saline (0.05ml), Vitrase (75 IU, 0.05ml), SF6 gas (0.3ml) and Vitrase plus SF6 gas 4 weeks later. Assessments for PVD were made through week 16 and compared to baseline. Seven-field fundus photographs were obtained at a surrogate baseline and 12 months later. Independent masked readers using ETDRS criteria graded photographs in order to determine the effect with or without regard to PVD and/or Vitrase on the progression of retinopathy. For eyes with a complete PVD on or prior to week 16, retinopathy scores at month 12 were compared to baseline. Results: For all eyes treated, without regard to PVD status, the percent of eyes with stable ETDRS scores were: saline 38% (6/16), Vitrase 67% (10/15), SF6 40% (6/15) and Vitrase plus SF6 43% (6/14). Worsening of ETDRS scores was seen in: saline 38% (6/16), Vitrase 13% (2/15), SF6 20% (3/15) and Vitrase plus SF6 21% (3/14). Photographs were not evaluable for the remaining eyes. Percent of eyes with a complete PVD on or prior to 16 weeks and stable ETDRS scores were: saline 0% (0/14), Vitrase 50% (6/12), SF6 30% (3/10) and Vitrase plus SF6 40% (4/10). The number and percent of study eyes with ocular adverse events were similar among study groups. Reduced visual acuity across all treatment groups in these diabetic eyes was the most frequently reported ocular adverse event. Conclusion: A higher proportion of eyes treated with Vitrase had stable ETDRS retinopathy scores as compared to saline. Of eyes treated with saline, the proportion that had stable ETDRS scores was equivalent to those that worsened. Importantly, the percent of eyes with a complete PVD and stable ETDRS scores was highest in the eyes treated with Vitrase. These data suggest that induction of a PVD and/or enzymatic liquefaction of the vitreous may have the potential to affect the progression of diabetic retinopathy. Although no statistical conclusions can be made, the results support further clinical investigation.

Keywords: 357 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 388 diabetic retinopathy • 629 vitreous 

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