September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Impact of Baseline Characteristics on Change in Diabetic Retinopathy Severity Scale (DRSS) Score in the VISTA and VIVID Studies
Author Affiliations & Notes
  • Dilsher Dhoot
    California Retina Consultants, Santa Barbara, California, United States
  • Footnotes
    Commercial Relationships   Dilsher Dhoot, Regeneron Pharmaceuticals, LLC (R)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2088. doi:
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      Dilsher Dhoot; Impact of Baseline Characteristics on Change in Diabetic Retinopathy Severity Scale (DRSS) Score in the VISTA and VIVID Studies. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2088.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : To evaluate the influence of baseline clinical characteristics and treatment factors on improvement of DRSS scores at week 100 compared with baseline.

Methods : VISTA and VIVID were double-masked, phase 3 trials randomizing 466 and 406 DME patients, respectively, to receive intravitreal aflibercept injection (IAI) 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks following 5 initial monthly doses (2q8), or laser. Change in DRSS score was an exploratory endpoint at week 100. The objective of this ad hoc analysis was to determine, using observed data, what factors influenced ≥2-step improvement in DRSS scores at week 100. Factors considered were baseline age, gender, race, HbA1c level, duration of diabetes, best-corrected visual acuity (BCVA), central retinal thickness (CRT), and baseline DRSS score. Regression analysis was performed to determine the impact of these factors.

Results : In the integrated VIVID and VISTA studies, 10.2%, 34.7% (p = .0018), and 38.5% (p < .001) of laser, 2q4, and 2q8 patients, respectively, experienced a ≥2-step improvement in DRSS score at week 100 compared with baseline. Baseline DRSS score was the only factor significantly associated with ≥2-step DRSS score improvement (p < .0001). Age, gender, race, HbA1c level, duration of diabetes, BCVA and CRT did not have an impact on the ability to gain ≥2-step improvement in DRSS score. The most frequent ocular serious adverse event from baseline to week 100 was cataract (2.4%, 1.0%, and 0.3% for the 2q4, 2q8, and laser groups, respectively) in a pooled analysis of VISTA and VIVID.

Conclusions : Overall, a significant proportion of patients in the VIVID and VISTA trials experienced at least a 2-step improvement in DRSS score at week 100. Baseline DRSS score was the most significant identified factor associated with ≥2-step improvement in DRSS score at week 100.

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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