Prospective Randomized Subject-Masked Study of Intravitreal Bevacizumab Monotherapy Versus Dexamethasone Implant Monotherapy in the Treatment of Persistent Diabetic Macular Edema

Shah, Sanket U.; Harless, Ashley; Bleau, Laura; Maturi, Raj K.

doi:10.1097/iae.0000000000001038

Cited by 45 publications

(52 citation statements)

References 21 publications

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“…Good baseline BCVA was correlated with good visual outcome; however, the amount of improvement was higher in patients with poor baseline BCVA. This inverse correlation of BCVA improvement with baseline BCVA represents a ceiling effect, as previously described [ 13 ]. In addition, the increased number of previous anti-VEGF injections and long duration of DME were associated with poor BCVA of 20 / 100 or less at month 3.…”

Section: Discussionsupporting

confidence: 61%

Prognostic Factors for Functional and Anatomic Outcomes in Patients with Diabetic Macular Edema Treated with Dexamethasone Implant

Lee

Kang

Chung

et al. 2018

Korean J Ophthalmol

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PurposeTo investigate the prognostic factors of visual and anatomic outcomes in patients with diabetic macular edema (DME) treated with intravitreal injection of dexamethasone implant.MethodsWe retrospectively studied 32 eyes of 31 patients with DME for best-corrected visual acuity (BCVA), central macular thickness, and height and width of both intraretinal fluid (IRF) and subretinal fluid. Logistic regression analysis was used to examine correlations between the baseline characteristics and outcomes at 3 and 6 months.ResultsBaseline predictor of BCVA ≥20 / 40 at month 3 was short height of baseline IRF (p = 0.02), while good baseline BCVA was a predictor for month 6 (p = 0.01). Predictors of improvement in logarithm of minimum angle of resolution BCVA 0.2 at month 3 were the absence of baseline IRF and poor baseline BCVA (p = 0.02 and p = 0.009, respectively), while poor baseline BCVA was the sole predictor at month 6 (p = 0.01). Predictor of central macular thickness ≤300 µm at month 3 was younger age (p = 0.03), while the absence of IRF was the predictor for BCVA improvement at month 6 (p = 0.02). BCVA ≤20 / 100 at month 3 was predicted by poor baseline BCVA (p = 0.01), and increased width of total IRF was the predictor at month 6 (p = 0.02). Predictor of loss of logarithm of minimum angle of resolution BCVA 0.2 at month 6 was increased width of total IRF at baseline (p = 0.04). Additional injection within 6 months was negatively associated with the presence of baseline DME (p = 0.03).ConclusionsThe visual and anatomical outcome of DME treatment with dexamethasone implant can be predicted by baseline visual acuity and IRF morphology.

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Section: Discussionsupporting

confidence: 61%

Prognostic Factors for Functional and Anatomic Outcomes in Patients with Diabetic Macular Edema Treated with Dexamethasone Implant

Lee

Kang

Chung

et al. 2018

Korean J Ophthalmol

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“…(%) BCVA at baseline CST/CMT (μm) at baseline Follow-up duration (months) Gillies et al 2014 < The BEVORDEX Study> [ 23 ] Australia DR DEX: 46 IVB: 42 DEX: 0.7 mg every 16 weeks + PRN IVB: 0.5 mg every 4 weeks + PRN DEX: 2.7 IVB: 8.6 DEX: 61.4 ± 9.0 IVB: 62.2 ± 10.5 ( P = 0.71) DEX: 16 (35%) IVB: 16 (38%) ( P = 0.83) DEX: 55.5 ± 12.5 IVB: 56.3 ± 11.9 ( P = 0.75) DEX: 474.3 ± 95.9 IVB: 503 ± 140.9 ( P = 0.38) 12 Allergan 2015 [ 27 ] Multiple countries: Belgium, Denmark, France, Germany, Israel, Italy, Netherlands, Portugal, South Africa, Spain, United Kingdom, United States DR DEX: 181 IVR: 182 DEX: 0.7 mg on Day 1, Month 5, and Month 10 IVR: 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression NA NA DEX: 69 (38%) IVR: 66 (36%) DEX: 60.2 ± 9.74 IVR: 60.4 ± 9.34 DEX: 465.1 ± 136.09 IVR: 471.2 ± 139.51 12 Shah et al 2016 [ 24 ] Indiana, United States DR DEX: 27 IVB: 23 DEX: 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections IVB: 1.25 mg given monthly during a 6 month period DEX: 2.7 ± 0.5 IVB: 7.0 ± 0.2 ( P < 0.001) DEX: 65 ± 11 IVB: 61 ± 9 ( P = 0.209) DEX: 15 (56%) IVB: 10 (44%) ( P = 0.571) DEX: 59 ± 12 IVB: 59 ± 13 ( P = 0.770) DEX: 458 ± 100 IVB: 485 ± 122 ( P = 0.508) 7 Gallemore et al 2017 [ 26 ] California, United States DR DEX: 10 IVB: 10 DEX: Ozurdex, 0.7 mg given at initial visit and at month 4 (visit 5) IVB: 1.25 mg given at initial visit and Q1 month for a total of 5 treatments NA DEX: 63.9 ± 1.8 IVB: 61.2 ± 2.9 <...>…”

Section: Methodsmentioning

confidence: 99%

A meta-analysis of the effect of a dexamethasone intravitreal implant versus intravitreal anti-vascular endothelial growth factor treatment for diabetic macular edema

Ren

et al. 2018

BMC Ophthalmol

101

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BackgroundThis meta-analysis evaluated the effectiveness and safety of dexamethasone (DEX) implant and intravitreal anti-vascular endothelial growth factor (VEGF) treatment for diabetic macular edema (DME).MethodsThe PubMed, Embase, clinicaltrials.gov website and Cochrane Library databases were comprehensively searched for studies comparing DEX implant with anti-VEGF in patients with DME. Best-corrected visual acuity (BCVA), central subfield thickness (CST) and adverse events were extracted from the final eligible studies. Review Manager (RevMan) 5.3 for Mac was used to analyze the data and GRADE profiler were used to access the quality of outcomes.ResultsBased on four randomized clinical trials assessing a total of 521 eyes, the DEX implant can achieve visual acuity improvement for DME at rates similar to those achieved via anti-VEGF treatment (mean difference [MD] = − 0.43, P = 0.35), with superior anatomic outcomes at 6 months (MD = − 86.71 μm, P = 0.02), while requiring fewer injections, in comparison to anti-VEGF treatment. Although the mean reduction in CST did not showed significant difference at 12 months (MD = − 33.77 μm, P = 0.21), the significant in BCVA from baseline to 12 months supported the anti-VEGF treatment (MD = − 3.26, P < 0.00001). No statistically significant differences in terms of the serious adverse events. However, use of the DEX implant has higher risk of intraocular pressure elevation and cataract than anti-VEGF treatment.ConclusionsCompared with anti-VEGF, DEX implant improved anatomical outcomes significantly. However, this did not translate to improved visual acuity, which may be due to the progression of cataract. Therefore, the DEX implant may be recommended as a first chioce for select cases, such as for pseudophakic eyes, anti-VEGF-resistant eyes, or patients reluctant to receive intravitreal injections frequently.Electronic supplementary materialThe online version of this article (10.1186/s12886-018-0779-1) contains supplementary material, which is available to authorized users.

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“…They are beneficial and safe for the treatment of DME. Only ranibizumab and aflibercept are approved by the Food and Drug Administration (FDA) for this indication 8–10…”

Section: Introductionmentioning

confidence: 99%

Intravitreal aflibercept versus intravitreal ranibizumab for the treatment of diabetic macular edema

Fouda¹,

Bahgat²

2017

OPTH

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PurposeThe purpose of this study was to compare the efficacy of intravitreal aflibercept and ranibizumab in the treatment of diabetic macular edema (DME) in eyes with moderate visual loss.Patients and methodsThis study is a randomized prospective study. Seventy eyes with DME were divided into two groups (each containing 35 eyes). Eyes in group I were treated with intravitreal injection of 2 mg/0.05 mL aflibercept and eyes in group II were treated with intravitreal injection of 0.5 mg/0.1 mL ranibizumab. All the eyes had three successive injections as a loading dose (with 1 month interval), and then the patients were followed up monthly for 12 months. The outcomes of the study were visual acuity, central macular thickness (CMT), and the number of re-injections of the drug.ResultsMean age of the patients in group I was 55.05±4.7 years and in group II was 56.64±5.8 years (P=0.17). The mean baseline best corrected visual acuity (BCVA) of eyes treated with aflibercept was 0.17±0.05 and with ranibizumab was 0.18±0.04 (P=0.9). BCVA was improved in both the groups at the end of the follow-up period and was found to be 0.42±0.28 and 0.37±0.23, respectively (P=0.27). The mean baseline CMT of eyes in group I was 465.29±33.7 µm and in group II was 471.5±34.4 µm (P=0.65). CMT decreased in both the groups to 360.8±85.7 µm and 387.3±87.8 µm, respectively (P=0.2). The mean number of drug re-injection was 2.62±0.68 and 3.03±0.95 in both the groups, respectively (P=0.02).ConclusionAflibercept and ranibizumab have the same efficacy in the treatment of DME in eyes with moderate visual loss but with less number of drug re-injection and less treatment burden with aflibercept (2.62±0.68 versus 3.03±0.95).

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Prospective Randomized Subject-Masked Study of Intravitreal Bevacizumab Monotherapy Versus Dexamethasone Implant Monotherapy in the Treatment of Persistent Diabetic Macular Edema

Cited by 45 publications

References 21 publications

Prognostic Factors for Functional and Anatomic Outcomes in Patients with Diabetic Macular Edema Treated with Dexamethasone Implant

Prognostic Factors for Functional and Anatomic Outcomes in Patients with Diabetic Macular Edema Treated with Dexamethasone Implant

A meta-analysis of the effect of a dexamethasone intravitreal implant versus intravitreal anti-vascular endothelial growth factor treatment for diabetic macular edema

Intravitreal aflibercept versus intravitreal ranibizumab for the treatment of diabetic macular edema

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