Dexamethasone intravitreal implant (Ozurdex) in diabetic macular edema: real-world data versus clinical trials outcomes

Abstract

AIM: To investigate the safety and efficacy of intravitreal dexamethasone implants (Ozurdex®/DEX) in patients with diabetic macular edema (DME) either naïve or non-naïve to anti-VEGF therapies who switched to DEX implant independent of response to anti-vascular endothelial growth factors (anti-VEGFs). METHODS: This was an audit retrospective review of medical records of patients with DME who switched to the DEX intravitreal implant. Patients were divided into 2 groups: patients naïve to antiangiogenic therapy and patients who were previously treated with anti-VEGFs. Data regarding demographics, changes in mean best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) was collected over 6mo. The demographic data mean changes in BCVA, CMT, and IOP were compared. Six-month follow-up data of 47 patients (57 eyes), who either switched to DEX implant irrespective of response to previous treatments or were treatment naïve before receiving DEX implant, was collected. RESULTS: Improvement in mean BCVA was observed from 1-4mo after injection with a decreased effect at month 6 as expected, with better outcomes in naïve compared to non-naïve patients. A statistically relevant decrease in mean CMT was observed during the follow-up period. An increase in mean IOP was observed in the first 2mo after DEX therapy. The mean number of injections of the overall population during the 6mo was 1.3. A subgroup analysis showed no relevant difference between phakic versus pseudophakic patients relative to measured outcomes. There was no cataract progression during the follow-up period and no adverse events reported. CONCLUSION: This real-life setting study shows that intravitreal DEX implant is effective and safe. The timings of greater therapeutic impact are concordant with previous studies and suggest that earlier treatment with corticosteroids may have an additional benefit in naïve patients.

Dexamethasone intravitreal implant in diabetic macular oedema refractory to anti-vascular endothelial growth factors: the AUSSIEDEX study

“…These findings should thus be interpreted with caution, especially as the early- vs late-switch subgroups were not compared in a randomised study in which—for example—patients who do not respond to the initial loading doses (3) of anti-VEGF would be randomised to early switch or late switch (based on predetermined numbers of anti-VEGF injections) before non-responders are identified and switched to treatment with DEX. Finally, although the study completion rate was not ideal (79.0%), it is worth noting that the number of patients who completed the current study (n=113) is higher than that included in various retrospective studies reporting real-world evidence on the effects of early vs late switch (n≤69 patients) 7 9 10 32. Additionally, it is higher than that previously published for the treatment-naïve subgroup (72%) of the prospective AUSSIEDEX study 13…”

Anatomical and visual outcomes of Retreatment with Intravitreal Dexamethasone Implant versus shifting to intravitreal Aflibercept for refractory Diabetic macular edema after an initial Intravitreal Dexamethasone Implant.

“…Our study may provide more insight regarding the effects of DEX implant retreatments on eyes with refractory DME observing a sample size of 58 eyes, over a long follow-up duration (12 months), compared to other studies. 27 we report an average 191 u reduction in CMT using an average 2 dexamethasone implant retreatments over 12 months, which is more favorable than 79 u using 2 implant retreatments over 12 months by Bhandari and coauthors (2022) 28 .…”

“…Retreatment with Dexamethasone implants was administered at four monthly intervals based on the sustained slow release of Dexamethasone 23 . We used a 4-months interval (not a six month interval) for evaluation for retreatment, compared to a 6-months interval that had been used in other studies 23,27 .…”

Real-world effectiveness of intravitreal dexamethasone implants - Comparison between eyes eligible and ineligible for clinical trials and their associated outcomes

“…and Neves et al. reported that VA did not change during treatment in real-world patients with RVO and DME, respectively [ 31 , 32 ]. Such differences suggest that more data from real-world eyes receiving IDIs are needed to better understand real-world factors and their effects on dexamethasone implant efficacy in treating macular edema.…”