Switching to Aflibercept in Diabetic Macular Edema Not Responding to Ranibizumab and/or Intravitreal Dexamethasone Implant

Abstract

Purpose To assess short-term functional and anatomical outcomes of refractory diabetic macular edema (DME) following a switch from ranibizumab or dexamethasone to aflibercept. Methods We included retrospectively eyes with persistent DME after at least 3 ranibizumab and/or one dexamethasone implant intravitreal injections (IVI). The primary endpoint was the mean change in visual acuity (VA) at month 6 (M6) after switching. Results Twenty-five eyes were included. Before switching to aflibercept, 23 eyes received a median of 9.5 ranibizumab, and among them, 6 eyes received one dexamethasone implant after ranibizumab and 2 eyes received only one dexamethasone implant. Baseline VA, before any IVI, was 52.9 ± 16.5 letters, and preswitch VA was 57.1 ± 19.6 letters. The mean VA gain was +8 letters (p = 0.01) between preswitch and M6. The mean central retinal thickness was 470.8 ± 129.9 μm before the switch and 303.3 ± 59.1 μm at M6 (p = 0.001). Conclusion Switching to aflibercept in refractory DME results in significant functional and anatomical improvement. The study was approved by the France Macula Federation ethical committee (FMF 2017-138).

Pharmacological Management of Diabetic Macular Edema in Real-Life Observational Studies

“…By analyzing the results according to the patient's baseline status, we found, in the anti-VEGF studies, a mean gain of + 5 letters for 5.2 IVI in naïve patients (BVA 56 letters) [ 15 , 19 , 24 , 27 , 28 , 30 , 37 ] and + 4.8 letters for 6.2 IVI in patients non-naïve to one or more previous treatments (BVA 56.9 letters) [ 16 , 20 , 21 , 23 , 29 , 31 , 32 , 38 , 42 ].…”

“…For subgroups with BVA of between 50 and 60 letters, there is a mean gain of + 5.8 letters in the anti-VEGF studies [ 14 , 15 , 21 , 23 – 25 , 33 , 35 , 37 – 39 , 45 ] (mean BVA of 55.7 letters) and + 9.3 letters in the DEX-implant studies [ 13 , 46 , 47 , 49 , 50 , 52 – 54 , 56 , 57 , 61 – 63 , 65 – 67 , 69 , 71 , 74 ] (mean BVA of 54.1 letters) with mean follow-up of 16.3 months for a mean of 5.8 IVI and 11.6 months for a mean of 1.75 IVI, respectively.…”

“…This lower level of VA in the DEX studies may relate to the fact that DEX-implant remains a second-line treatment in routine practice [ 8 ], thus explaining that the patients included in these studies are mostly non-naïve patients, with a long duration of DME, and therefore lower VA. Regarding the studies selected here, 9/32 anti-VEGF studies only concern non-naïve patients [ 16 , 20 , 21 , 23 , 29 , 31 , 32 , 38 , 42 ] with a mean duration of DME of 30.5 months, compared to 19/31 for DEX studies [ 13 , 26 , 46 , 47 , 49 – 57 , 64 , 69 – 73 ] with a similar duration of DME (26.8 months). Nevertheless, the mean numbers of treatments are quite different between the anti-VEGF studies and DEX studies with a mean number of 10.7 and 5.4 treatments before switching, respectively, which could constitute a bias.…”

“…Concerning the real-life studies evaluated in present analysis, similar side effects have been reported in anti-VEGF and DEX studies ( Table 1 ). Concerning the anti-VEGF studies, the incidence of cataract formation was between 0% and 15.4% [ 14 , 20 , 21 , 24 , 26 , 28 , 41 , 42 ]. None of the studies reported statistically significant elevation of IOP in anti-VEGF studies, but the mean follow-up was only 15 months.…”

Baseline SD-OCT characteristics of diabetic macular oedema patterns can predict morphological features and timing of recurrence in patients treated with dexamethasone intravitreal implants

“…This provides the clinician with additional information that can help to individualize treatment with DEX-I and help in selecting patients who may be the most appropriate candidates for this therapy. For example, in patients who are predicted to relapse earlier, more frequent follow-up may be warranted in order to modulate treatment accordingly or to allow for earlier switching to another treatment, as with other therapies such as anti-VEGF [21]. One additional advantage of better prediction of relapse and time to relapse is that early implantation of DEX-I has been associated with better visual outcomes.…”