September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Variability in vitreous haze grading technique using a 9-step logarithmic scale in patients enrolled in the Sarilumab in Non-infectious Uveitis (SARIL-NIU), the Saturn Study
Author Affiliations & Notes
  • Marc D de Smet
    Ophthalmology, MIOS, Lausanne, Switzerland
  • Preethi A Sundaram
    Sanofi, Bridgewater, New Jersey, United States
  • Kristine Erickson
    Regeneron Pharmaceuticals, Tarrytown, New York, United States
  • Valerie Corp-dit-Genti
    Sanofi, Bridgewater, New Jersey, United States
  • Laetitia Vinet
    IT&M Stats, Paris, France
  • Robert Vitti
    Regeneron Pharmaceuticals, Tarrytown, New York, United States
  • Ronald BUGGAGE
    Sanofi, Bridgewater, New Jersey, United States
  • Quan Dong Nguyen
    Ophthalology, University of Nebraska, Omaha, Nebraska, United States
  • Footnotes
    Commercial Relationships   Marc de Smet, Allergan (C), Sanofi (C); Preethi Sundaram, Sanofi (E); Kristine Erickson, Regeneron (E); Valerie Corp-dit-Genti, sanofi (E); Laetitia Vinet, IT&M Stats (E), Sanofi (C); Robert Vitti, Regeneron (E); Ronald BUGGAGE, Sanofi (E); Quan Dong Nguyen, Regeneron (F), Sanofi (F)
  • Footnotes
    Support  R&D Sanofi, Inc
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      Marc D de Smet, Preethi A Sundaram, Kristine Erickson, Valerie Corp-dit-Genti, Laetitia Vinet, Robert Vitti, Ronald BUGGAGE, Quan Dong Nguyen; Variability in vitreous haze grading technique using a 9-step logarithmic scale in patients enrolled in the Sarilumab in Non-infectious Uveitis (SARIL-NIU), the Saturn Study. Invest. Ophthalmol. Vis. Sci. 201657(12):.

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

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Abstract

Purpose : To perform a comparative evaluation of the agreement between clinical and reading center techniques of vitreous haze when using a 9-step logarithmic photographic vitreous haze (VH) scale (Miami scale – Davis et al 2010) for patients with active posterior segment uveitis in the clinical validation of this alternative to the Standardization of Uveitis Nomenclature (SUN) grading scale.

Methods : The SATURN study is a multicenter, double-masked, placebo-controlled, parallel, randomized study to evaluate sarilumab in patients with posterior NIU. VH at baseline was assessed with the 9-step Miami scale clinically by investigators using indirect ophthalmoscopy and by a reading center using digitized fundus photographs in a standardized environment. VH assessments performed by the investigators and adjudicated by a central reading center at baseline were compared.

Results : 58 subjects were randomized and treated in the study. VH assessments per investigator were available for all 58 patients at Screening (V1) and Randomization (V2) and for 57 patients per reading center adjudication and presented in Tables 1 and 2. Overall, there was agreement in VH assessment scores in 36.8% of patients at V1 (Table 1) and 29.8% of patients at V2. The VH score was less severe per adjudicated assessment than per Investigator in more than one-half of the patients at V1 (57.9%) and V2 (52.6%). The VH score was more severe per adjudicated assessment than per Investigator in 3 (5.3%) patients at V1 and 10 (17.5%) patients at V2. Overall, of the 30 patients where the VH score was less severe per adjudicated assessment at V2, a total of 12 (21.1%) patients showed a difference of more than 1-grade (12 [21.1%] patients with a 2-grade difference; 5 [8.8%] patients with a 3-grade difference; and 1 [1.8%]) patient with a 4-grade difference between the investigator and adjudicated assessments.

Conclusions : Our observations show a discrepancy between investigator assessments of VH clinically and reading center assessment of photographs. Reading center estimates of VH were most often lower than clinical assessments. Recognition of differences between the reading center and the clinical assessment of VH is important for selecting efficacy endpoints for investigational clinical trials.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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