Sequential Dexamethasone and Aflibercept Treatment in Patients with Diabetic Macular Edema: Structural and Functional Outcomes at 52 Weeks

Hernández-Bel, Laura; Cervera-Taulet, Enrique; Navarro-Palop, Catalina; Castro-Navarro, Verónica; Chiarri-Toumit, C.; Montero-Hernández, Javier

doi:10.1159/000489345

Cited by 11 publications

(11 citation statements)

References 16 publications

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“…9 In contrast, the results from trials with less strict PRN treatment criteria show diminished BCVA gains and fewer injections in year 1 compared with trials with more rigorous regimens. 6,9,24,25 When looking for baseline characteristics that may influence the outcome, we noted that the 12-month change in BCVA negatively correlated with baseline BCVA in patients with DME, which is consistent with prior studies noting a negative correlation between baseline BCVA and long-term BCVA change. 91,92 This has been described as a "ceiling effect" in which the visual acuity gained by anti-VEGF and dexamethasone implant use reaches a maximum over the time-course of treatment.…”

Section: Discussionsupporting

confidence: 88%

Managing Diabetic Macular Edema in Clinical Practice: Systematic Review and Meta-Analysis of Current Strategies and Treatment Options

Veritti

Sarao

Soppelsa

et al. 2021

OPTH

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Purpose This meta-analysis aims to summarize 12-month best-corrected visual acuity (BCVA) outcomes in response to anti-vascular endothelial growth factor (VEGF) therapy and dexamethasone implant for the treatment of diabetic macular edema (DME) and to identify factors affecting treatment response using evidence generated from meta-regression. Methods A systematic review of electronic databases was conducted to identify randomized controlled trials (RCTs) and real-life/observational studies that reported 12-month changes in BCVA in patients with DME on anti-VEGF or dexamethasone implant treatment in monotherapy. Study factors that were analyzed are baseline patient characteristics, study type, drug employed, number of injections and 12-month change in BCVA. Data were pooled in a random-effects meta-analysis with BCVA change as the main outcome. Meta-regression was conducted to assess the impact of multiple covariates. Results One-hundred-five heterogeneous study populations (45,032 eyes) were identified and included in the analysis. The use of anti-VEGFs and dexamethasone implant induced an overall increase of +8.13 ETDRS letters in BCVA at 12 months of follow-up. Meta-regression provided evidence that mean BCVA change using anti-VEGFs was not statistically higher for RCTs (p=0.35) compared to observational studies. Dexamethasone implant showed a trend for better results in observational studies over RCTs. Populations following a fixed aflibercept regimen performed better than those following a reactive treatment regimen. Mean BCVA gain was higher in younger populations (p<0.001), with lower baseline BCVA (p<0.0001) and longer diabetes duration (p<0.0001), receiving a higher number of injections (p<0.0001). Conclusion Intravitreal therapy with anti-VEGFs or dexamethasone implant produces a significant improvement in BCVA at 12 months in patients with DME. Meta-regression identified the modifiable covariates that can be targeted in order to maximize functional results.

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Section: Discussionsupporting

confidence: 88%

Managing Diabetic Macular Edema in Clinical Practice: Systematic Review and Meta-Analysis of Current Strategies and Treatment Options

Veritti

Sarao

Soppelsa

et al. 2021

OPTH

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“…Twenty-four studies commented on safety outcomes, including 14 studies reporting ocular adverse events 5 17 18 19 23 24 25 26 27 28 29 30 31 32 and 10 reporting no ocular adverse events with aflibercept. 15 16 20 21 22 33 34 35 36 37 The most commonly reported ocular adverse event was subconjunctival hemorrhage (164 cases of 2516 aflibercept-treated eyes with ocular safety data available, representing a prevalence of 6.5%). 24 26 27 30 31 32 Twelve studies reported APTC-defined adverse events with aflibercept treatment.…”

Section: R Esultsmentioning

confidence: 99%

Efficacy and safety of aflibercept therapy for diabetic macular edema: A systematic review and meta-analysis

et al. 2022

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Purpose: To assess the real-world efficacy and safety of aflibercept for the treatment of diabetic macular edema (DME). Methods: A systematic search was conducted across multiple databases. Articles were included if participants had DME and received aflibercept treatment for a minimum of 52 ± 4 weeks. Primary outcomes included changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). A risk of bias assessment of studies was completed, pooled estimates were obtained, and a meta-regression was performed. Information on adverse events was collected. Results: The search yielded 2112 articles, of which 30 were included. Aflibercept was more effective than laser photocoagulation functionally (12-month BCVA-weighted mean difference [WMD] = 10.77 letters, P < 0.001; 24 months = 8.12 letters, P < 0.001) and anatomically (12-month CMT WMD = –114.12 μm, P < 0.001; 24 months = –90.4 μm, P = 0.004). Compared to bevacizumab, aflibercept was noninferior at improving BCVA at 12 months (WMD = 1.71 letters, P = 0.34) and 24 months (WMD = 1.58 letters, P = 0.083). One study found that aflibercept was more effective than bevacizumab anatomically at 1 and 2 years ( P < 0.001 at 12 and 24 months). Compared to ranibizumab, aflibercept rendered a greater improvement in BCVA at 1 year (WMD = 1.76 letters, P = 0.001), but not 2 years (WMD = 1.66 letters, P = 0.072). CMT was not significantly different between both therapies at 12 months (WMD = −14.30 μm, P = 0.282) and 24 months ( P = 0.08). One study reported greater functional improvement with aflibercept compared with dexamethasone ( P = 0.004), but inferiority in reducing CMT ( P < 0.001). Meta-regression analysis demonstrated that dosing schedule was found to impact outcomes at 12 and 24 months, while study design and sample size did not impact outcomes at 12 months. There were minimal safety concerns using aflibercept therapy. Conclusions: Aflibercept is a safe and effective therapy option for DME in the clinical setting, performing superiorly to laser photocoagulation. Evidence regarding comparisons with bevacizumab, ranibizumab, and dexamethasone is mixed and limited.

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“…At start of treatment, intensive anti-VEGF treatment and DEX implant led to better functional and anatomical outcomes than less intense treatment. In another study, Hernández-Bel et al [ 24 ] reported that sequential intravitreal treatment in DMO starting with dexamethasone and followed by aflibercept was a reasonable alternative to treatment with aflibercept alone for reducing the burden of treatment over 12 months. A difference noted in comparison with our study was that the improvement in vision and the decrease in macular thickness were not statistically significant.…”

Section: Discussionmentioning

confidence: 99%

Intravitreal ranibizumab and dexamethasone implant injections as primary treatment of diabetic macular edema: simultaneously double protocol

Kaya

Koçak

Öztürk

et al. 2020

Eye

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Purpose To assess the 12-month efficacy and safety of simultaneously administered intravitreal dexamethasone implant (DEX implant) and ranibizumab (simultaneous double protocol) injections in comparison with ranibizumab monotherapy as the first-line treatment of diabetic macular oedema (DMO). Methods Prospective, consecutive, clinical interventional study. Patients were randomized into two groups: 24 naive DMO patients (34 eyes) who received simultaneous double-protocol therapy and 22 DMO patients (34 eyes) who received ranibizumab monotherapy were included. Monthly ranibizumab (0.5 mg) was administered for the first 6 months and later on, an as-needed treatment basis. DEX implant injection was performed at any time during the loading dose of the three consecutive monthly injections of ranibizumab, and with as-needed reinjections of ranibizumab from 6th month onwards. Change in visual acuity was the primary efficacy endpoint. Secondary efficacy endpoints were a gain of ≥15 letters and a change in the central foveal thickness. Results Mean BCVA increased from baseline to month 12 in the simultaneously double-protocol therapy group compared with the ranibizumab monotherapy group (21.6 versus 9.6 letters [P < 0.001]). The corresponding proportions of eyes gaining ≥15 letters were 60% versus 29.4% (P < 0.0001). Moreover, the mean reductions in the central foveal thickness were 413 versus 282 µm (P = 0.001). At 12 month, the simultaneous double-protocol therapy decreased a significant number of foveal cysts and subfoveal neuroretinal detachment compared with those by ranibizumab monotherapy. Conclusions The simultaneous addition of DEX implant at any time during the three monthly loading doses of ranibizumab in patients with DMO significantly improved the visual outcomes and revealed superior anatomic outcomes than those with the ranibizumab monotherapy.

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Sequential Dexamethasone and Aflibercept Treatment in Patients with Diabetic Macular Edema: Structural and Functional Outcomes at 52 Weeks

Cited by 11 publications

References 16 publications

Managing Diabetic Macular Edema in Clinical Practice: Systematic Review and Meta-Analysis of Current Strategies and Treatment Options

Managing Diabetic Macular Edema in Clinical Practice: Systematic Review and Meta-Analysis of Current Strategies and Treatment Options

Efficacy and safety of aflibercept therapy for diabetic macular edema: A systematic review and meta-analysis

Intravitreal ranibizumab and dexamethasone implant injections as primary treatment of diabetic macular edema: simultaneously double protocol

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