INVICTUS: Intravitreal anti-VEGF and dexamethasone implant comparison for the treatment of diabetic macular edema: A 12 months follow-up study

Abstract

<jats:sec><jats:title>Purpose:</jats:title><jats:p> To compare the efficacy of intravitreal injections (IVI) of ranibizumab (Lucentis<jats:sup>®</jats:sup>, Novartis, Basel, Switzerland; RAN), aflibercept (Eylea<jats:sup>®</jats:sup>, Bayer, Leverkusen, Germany; AFL) and dexamethasone implant (Ozurdex<jats:sup>®</jats:sup>, Allergan, Irvine, California; DXI) in the treatment of naive diabetic macular oedema (DME) during a 12-month follow-up, in real life. </jats:p></jats:sec><jats:sec><jats:title>Methods:</jats:title><jats:p> Nineteen eyes treated with RAN, 20 with AFL and 21 with DXI were analysed from inclusion up to 12 months (M12) with intermediate analysis at M6. Best corrected visual acuity (BCVA), fundus and central retinal thickness (CRT) using spectral-domain optical coherence tomography (SD-OCT; Spectralis/HRA, Heidelberg Engineering, Germany) were performed at inclusion, M3, M6 and M12. </jats:p></jats:sec><jats:sec><jats:title>Results:</jats:title><jats:p> BCVA improved until 67.9 letters ±13.3 SD (+5.5 letters) at M6 and 69.6 letters ±12 SD (+7.2 letters) at 12 months for RAN group ( p = 0.036). For the AFL group it improved until 63.6 letters ±15.2 SD (+6.6 letters) at M6 and 67.5 letters ±12.2 SD (+8.5 letters) at 12 months ( p = 0.014). Lastly DXI group improved by 66.9 letters ±15.1 SD (+7.9 letters) at M6 and 68.4 letters ±11.2 SD (+9.4 letters) at 12 months ( p = 0.0023). CRT decreased by 124.4 µm at M6 and 99.3 µm at M12 in RAN group, 144.3 µm and 101.5 µm in AFL group and finally 95.6 µm and 162.7 µm in DXI group. </jats:p></jats:sec><jats:sec><jats:title>Conclusion:</jats:title><jats:p> In summary, these three drugs provide an efficient treatment option with an acceptable benefit-risk ratio for the treatment of naive patients with DME, whether on BCVA or CRT on the first year of treatment. </jats:p></jats:sec>

Effectiveness and Safety of Coadministration of Intravitreal Dexamethasone Implant and Silicone Oil Endotamponade for Proliferative Diabetic Retinopathy with Tractional Diabetic Macular Edema

“…In the literature, many treatment methods have been identified in the treatment of DME. PRP, [7][8][9] grid or micropulse yellow laser, [10][11][12] intravitreal injection of anti-VEGF drugs, [13][14][15][16] subtenon or intravitreal injection of glucocorticoid drugs, 17,18 and PPV 19,20 are the most known options. PRP is a standard treatment that has been showing its benefit in PDR management for nearly 40 years by reducing VEGF release from ischemic areas.…”

Costs comparison of treating diabetic macular edema with aflibercept, ranibizumab or dexamethasone at 1 year in France (INVICOST study)

“…Despite this limitation, it should be noted that there was no significant difference between the three treatment groups in proportion of phakic patients at baseline (59% in AFL group, and 57% in DXI group and 53% in RAN group). 9…”

“…The efficacy and safety of RAN and AFL in the treatment of DME have been compared in at least one large, multicentre, randomized trial, 8 but there is a paucity of data comparing the differences between corticosteroids and these agents. The INVICTUS study was the first to compare the efficacy of these three treatments (RAN, AFL and DXI) with 6-month 9 and 12-month follow-up 10 in a real-life setting in France.…”

“…In this prospective, open-label monocentric INVICTUS study, 9,10 consecutive patients with treatment-naïve DME were enrolled. No significant differences in baseline characteristics including visual acuity, central retinal thickness (CRT) and glycated hemoglobin were reported.…”

“…Intraocular pressure was stable in the AFL and RAN groups and 19% ( n = 4) of patients experienced an IOP ⩾25 mmHg or an increase ⩾10 mmHg controlled with local treatment. 9,10 Using the data from INVICTUS, we performed a cost-minimization analysis to compare healthcare resource utilization (HCRU) and associated costs of managing DME with each of these agents.…”