Pharmaceutics (Feb 2021)

Visual Acuity Gain Profiles and Anatomical Prognosis Factors in Patients with Drug-Naive Diabetic Macular Edema Treated with Dexamethasone Implant: The NAVEDEX Study

  • Mauricio Pinto,
  • Thibaud Mathis,
  • Pascale Massin,
  • Jad Akesbi,
  • Théo Lereuil,
  • Nicolas Voirin,
  • Frédéric Matonti,
  • Franck Fajnkuchen,
  • John Conrath,
  • Solange Milazzo,
  • Jean-François Korobelnik,
  • Stéphanie Baillif,
  • Philippe Denis,
  • Catherine Creuzot-Garcher,
  • Mayer Srour,
  • Bénédicte Dupas,
  • Aditya Sudhalkar,
  • Alper Bilgic,
  • Ramin Tadayoni,
  • Eric H Souied,
  • Corinne Dot,
  • Laurent Kodjikian

DOI
https://doi.org/10.3390/pharmaceutics13020194
Journal volume & issue
Vol. 13, no. 2
p. 194

Abstract

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The purpose of this study is to evaluate the visual acuity (VA) gain profiles between patients with drug-naive diabetic macular edema (DME) treated by dexamethasone implant (DEX-implant) and assess the baseline anatomical and functional factors that could influence the response to the treatment in real-life conditions. A retrospective, multi-center observational study included 129 eyes with drug-naive DME treated by DEX-implant. The Median follow-up was 13 months. Two groups of VA gain trajectories were identified—Group A, with 71% (n = 96) of patients whose average VA gain was less than five letters and Group B, with 29% (n = 33) of patients with an average gain of 20 letters. The probability of belonging to Group B was significantly higher in patients with baseline VA p = 0.001). Ellipsoid zone alterations (EZAs) or disorganization of retinal inner layers (DRILs) were associated with a lower final VA (53.0 letters versus 66.4, p = 0.002) but without a significant difference in VA gain (4.9 letters versus 6.8, p = 0.582). Despite a low baseline VA, this subgroup of patients tends to have greater visual gain, encouraging treatment with DEX-implant in such advanced-stage disease. However, some baseline anatomic parameters, such as the presence of EZAs or DRILs, negatively influenced final vision.

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