June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
The CONSTANT study: area-under-the-curve (AUC) analysis comparing fluocinolone acetonide 0.2µg/day (ILUVIEN®) implant with ranibizumab plus deferred laser over a 36-month study period
Author Affiliations & Notes
  • Daniel M Miller
    Ophthalmology, Cincinnati Eye Institute/University of Cincinnati, Cincinnati, Ohio, United States
  • Footnotes
    Commercial Relationships   Daniel Miller, Alcon (F), Alimera (C), Bausch and Lomb (C), Genentech (F), Regeneron (F), Vortex (I)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 931. doi:
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      Daniel M Miller; The CONSTANT study: area-under-the-curve (AUC) analysis comparing fluocinolone acetonide 0.2µg/day (ILUVIEN®) implant with ranibizumab plus deferred laser over a 36-month study period. Invest. Ophthalmol. Vis. Sci. 2017;58(8):931.

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

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Abstract

Purpose : Unlike single time-point outcomes, AUC analysis estimates letters gained per day over the entire treatment period, therefore providing an indication of long-term effectiveness and the stability of therapy. Here, AUC for fluocinolone acetonide 0.2µg/day (FAc) implant was compared with the publicly available (DRCR.net) ranibizumab plus deferred laser arm (referred to as ranibizumab) dataset from Protocol I, in order to evaluate these treatments for diabetic macular edema (DME).

Methods : Best-corrected visual acuity (BCVA) letter score was used to calculate AUC over a 36-month period. For each subject, the summarized variable represented total AUC divided by number of days in study to give letters per day. AUC analysis was performed for the FAME study (combining FAME A and B trial results) and compared with that for the ranibizumab plus deferred laser arm from Protocol I. Subgroup analyses were also conducted in DME patients with pseudophakic lenses to exclude the effect of cataract formation on visual acuity.

Results : In the overall DME populations, 36-month AUC was significantly greater for ranibizumab than FAc (8.43 vs 5.18 letters/day, respectively; P=0.0015), which resulted from cataract formation in the FAc group and a resulting reduction in AUC. In the pseudophakic DME subgroups, however, AUC was not significantly different between ranibizumab and FAc groups (7.62 vs 7.11 letters/day, respectively; P=0.7658) (Fig. 1). In terms of injection frequency, over the 36-month period, the ranibizumab group received an average of 14 injections compared with a mean of only 1.3 injections with FAc implant.

Conclusions : AUC calculations in pseudophakic DME eyes that were not affected by the development of cataract showed numerically and statistically comparable (P>0.05) visual outcomes for ranibizumab and the FAc implant. These outcomes were obtained with fewer injections over the 36-month study period.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

Fig. 1: 0.2µg/day FAc versus ranibizumab plus deferred laser over a 36-month study period in pseudophakic eyes

Fig. 1: 0.2µg/day FAc versus ranibizumab plus deferred laser over a 36-month study period in pseudophakic eyes

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