Ranibizumab or Aflibercept for Diabetic Macular Edema

Bhandari, S.; Nguyen, Vuong; Fraser‐Bell, Samantha; Mehta, Hemal; Viola, Francesco; Baudin, Florian; Gabrielle, Pierre‐Henry; Creuzot‐Garcher, Catherine; Gillies, Mark C; Barthelmes, Daniel

doi:10.1016/j.ophtha.2019.11.018

Cited by 47 publications

(35 citation statements)

References 24 publications

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“…While statistically significant, the difference of one injection over 12 months is likely not clinically meaningful. Interestingly, the frequency of injection in our study was similar to a number of RCTs for DMO (median=8–9) 31 32 and higher than other real-world studies (median=5–8), 33–35 thus ruling out undertreatment. In addition, DMO is a highly complex disease and there may be other unexplored causes of poor outcomes in DMO patients, including genetic, epigenetic and environmental factors.…”

Section: Discussionsupporting

confidence: 85%

Comparing vision and macular thickness in neovascular age-related macular degeneration, diabetic macular oedema and retinal vein occlusion patients treated with intravitreal antivascular endothelial growth factor injections in clinical practice

et al. 2021

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ObjectiveTo compare the visual outcomes of intravitreal antivascular endothelial growth factor (anti-VEGF) injections in neovascular age-related macular degeneration (nAMD), diabetic macular oedema (DMO) and retinal vein occlusion (RVO) in a real-world setting.Methods and analysisRetrospective analysis of data from the Tasmanian Ophthalmic Biobank database. The median change in best-corrected visual acuity (BCVA) between baseline and 12 months post initiating intravitreal anti-VEGF treatment were compared between the three diseases. Final BCVA, central macular thickness (CMT), cumulative number of injections and overall predictors of change in BCVA and CMT were also determined.ResultsAt 12 months, change in BCVA was significantly different between nAMD, DMO and RVO cohorts (p=0.032), with lower median change for DMO (2 letters, range −5 to 20) than for RVO (11 letters, range −20 to 35). Likewise, CMT change was significantly different between the three cohorts (p=0.022), with a smaller reduction in CMT in DMO (−54 µm, range −482 to 50) than RVO patients (−137 µm, range −478 to 43; p=0.033). Total number of injections received (p=0.028) and final BCVA score (p=0.024) were also significantly different between the groups. Baseline BCVA was a negative predictor (p=0.042) and baseline CMT a positive predictor (p<0.001) of outcome. After adjusting for baseline BCVA and CMT, diagnosis of nAMD or RVO was a predictor of visual improvement compared with the DMO.ConclusionsAt the end of 12 months, nAMD and RVO cohorts had the greatest improvement in BCVA, however the final BCVA for DMO was significantly better than for nAMD.

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Section: Discussionsupporting

confidence: 85%

Comparing vision and macular thickness in neovascular age-related macular degeneration, diabetic macular oedema and retinal vein occlusion patients treated with intravitreal antivascular endothelial growth factor injections in clinical practice

et al. 2021

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“…4 In pivotal clinical studies, bevacizumab (Avastin, Genentech, San Francisco, California, USA), [6][7][8][9] ranibizumab (Lucentis, Genentech) [10][11][12] and aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York, USA) 13 14 effectively improved both visual and anatomic outcomes in DME. The treatment burden associated with anti-VEGF agents can be high as frequent injections 15 16 and monitoring/follow-up visits [17][18][19][20] are often needed, and not all eyes respond optimally to anti-VEGF therapy. 21 Intravitreal corticosteroids provide broader anti-inflammatory effects, inhibiting synthesis of VEGFs and other proinflammatory mediators leading to DME.…”

Section: Introductionmentioning

confidence: 99%

Dexamethasone intravitreal implant in treatment-naïve diabetic macular oedema: findings from the prospective, multicentre, AUSSIEDEX study

Fraser‐Bell

Kang²,

Mitchell

et al. 2021

Br J Ophthalmol

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AimTo evaluate the effectiveness of dexamethasone intravitreal implant 0.7 mg (DEX; Ozurdex) monotherapy in the patient subgroup of the AUSSIEDEX study with treatment-naïve diabetic macular oedema (DME).MethodsThe open-label, prospective, phase 4, real-world study included pseudophakic eyes and phakic eyes scheduled for cataract surgery that were treatment-naïve or non-responsive to antivascular endothelial growth factors. No eyes were excluded based on baseline best-corrected visual acuity (BCVA) or central subfield retinal thickness (CRT). After the initial DEX injection at the baseline visit, reinjection was permitted at ≥16-week intervals. Week-16 and week-52 visits were mandatory. Primary endpoints were changes in mean BCVA and CRT from baseline to 52 weeks.ResultsOf 200 eyes enrolled in the AUSSIEDEX study, 57 were treatment-naïve. Baseline mean BCVA was 58.8 letters and baseline mean CRT was 418.6 µm; changes in mean BCVA and CRT from baseline to 52 weeks in this subgroup were 3.4 letters (p=0.042) and –89.6 µm (p<0.001), respectively, with a mean 2.5 injections. The change in mean CRT from baseline was –55.8 µm at week 16 (p<0.001). The most common adverse event was increased intraocular pressure (IOP), with 20.0% of eyes requiring IOP-lowering medication. One patient was discontinued due to increased IOP. No eyes required filtration surgery. No serious, treatment-related ocular adverse events were reported.ConclusionIn this largest prospective, real-world study of DEX monotherapy for DME to date, DEX significantly improved CRT and BCVA at 52 weeks in treatment-naïve eyes, without new safety concerns, supporting DEX use in treatment-naïve DME.Trial registration numberNCT02731911.

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“…Another retrospective RWE study from the FRB! Registry [ 38 ] compared ranibizumab and aflibercept for DMO at 12 months for each drug in routine clinical practice. A total of 383 eyes were included (ranibizumab, n = 166 eyes; aflibercept, n = 217 eyes).…”

Section: Diabetic Retinopathy and Macular Oedemamentioning

confidence: 99%

A Review of Aflibercept Treatment for Macular Disease

et al. 2021

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Aflibercept is a fully human recombinant fusion protein that includes the second domain of human VEGF receptor 1 and the third domain of human VEGF receptor 2. Despite the important role played by VEGF in maintaining the physiological condition of the retina under normal conditions, dysregulation of VEGF can result in pathological alterations including hyperpermeability of the retinal capillaries and migration and proliferation of retinal endothelial cells. Over the years, a number of studies have evaluated the use of intravitreal aflibercept in different retinal diseases. In this review, we aim to summarize the scientific evidence and recommendations for use of intravitreal aflibercept in neovascular age-related macular degeneration, diabetic macular oedema, macular oedema associated with retinal vein occlusion, and myopic choroidal neovascularization.

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Ranibizumab or Aflibercept for Diabetic Macular Edema

Cited by 47 publications

References 24 publications

Comparing vision and macular thickness in neovascular age-related macular degeneration, diabetic macular oedema and retinal vein occlusion patients treated with intravitreal antivascular endothelial growth factor injections in clinical practice

Comparing vision and macular thickness in neovascular age-related macular degeneration, diabetic macular oedema and retinal vein occlusion patients treated with intravitreal antivascular endothelial growth factor injections in clinical practice

Dexamethasone intravitreal implant in treatment-naïve diabetic macular oedema: findings from the prospective, multicentre, AUSSIEDEX study

A Review of Aflibercept Treatment for Macular Disease

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