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

Abstract

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 < 37 letters (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.

Optical Coherence Tomography Biomarkers in Predicting Treatment Outcomes of Diabetic Macular Edema After Dexamethasone Implants

“…More importantly, we performed multivariate analysis and lens status was not significantly associated with outcomes. Previous studies have found similar conclusions that the lens status was not significantly associated with differences in BCVA ( 10 , 27 ). Lastly, if we had divided our subjects into two groups, the smaller case number in each group would make the outcomes less reliable.…”

: Pro Re Nata brolucizumab for early onset and treatment-naïve diabetic macular edema: a prospective study

“…Our patient group presented with lower BCVA at baseline in comparison to the KITE & KESTREL studies, therefore permitting higher potential visual gains. 9,10 Moreover, in our study the DME was of recent onset and patients treatment naive, permitting higher potential gain in BCVA. 11 These functional outcomes were backed up by anatomical outcomes.…”

Fluocinolone acetonide implant in diabetic macular edema: International experts’ panel consensus guidelines and treatment algorithm

“…19,20 Therefore steroids appear effective at all stages of DME. 21 and while they may be perceived as particularly effective in chronic DME, studies have shown that, in patiens resistant to anti-VEGF, early switch to corticosteroid therapy offers better functional outcome. 22,23 Commonly used intravitreal GCs are triamcinolone acetonide (TA), the dexamethasone (DEX) intravitreal implant and the FAc implant.…”