Review of clinical studies and recommendation for a therapeutic flow chart for diabetic macular edema

Yoshida, Shigeo; Murakami, Tomoaki; Nozaki, Miho; Suzuma, Kiyoshi; Baba, Takayuki; Hirano, Toshio; Sawada, Osamu; Sugimoto, Masahiko; Takamura, Yoshihiro; Tsuiki, Eiko

doi:10.1007/s00417-020-04936-w

Cited by 28 publications

(26 citation statements)

References 109 publications

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“…The treatment options for DME in Japan are intravitreal anti-VEGF therapy, laser photocoagulation, intravitreal steroid therapy, and vitrectomy [ 4 ]. Anti-VEGF therapy was associated with better visual improvement compared with photocoagulation in patients with DME in the RESTORE and VIVID/VISTA studies [ 5 , 6 ], and 81.2% of ophthalmologists in Japan chose intravitreal anti-VEGF therapy as the first-line treatment for DME according to a survey conducted in 2016 and 2017 [ 7 ].…”

Section: Introductionmentioning

confidence: 99%

Intravitreal aflibercept for diabetic macular edema in real-world clinical practice in Japan: 24-month outcomes

Sugimoto

Handa

Hirano

et al. 2022

Graefes Arch Clin Exp Ophthalmol

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Purpose To report the safety and effectiveness of intravitreal aflibercept (IVT-AFL) for diabetic macular edema (DME) in the real-world clinical practice setting in Japan. Methods In this prospective, multicenter, observational, post-marketing surveillance, patients with DME newly receiving IVT-AFL were enrolled. During a 24-month follow-up, the primary outcome was the occurrence of safety events. Other pre-specified endpoints were effectiveness indicators, such as best-corrected visual acuity (BCVA), central retinal thickness, and injection frequency. Results In total, 646 patients administered at least one IVT-AFL injection were included in the safety analysis. During the follow-up period, adverse events occurred in 42 patients (6.50%), whereas adverse drug reactions occurred in 12 (1.86%). In the 12 patients who had adverse drug reactions, seven events occurred in seven patients within the first month of the most recent injection. In addition, 622 patients were included in the effectiveness analysis set. The number of injections over 24 months was 3.6 ± 3.0 (mean ± standard deviation [SD]). BCVA (logarithm of the minimum angle of resolution) was 0.437 ± 0.362 (mean ± SD) (n = 622) at baseline and 0.321 ± 0.348 (n = 177) after 24 months of treatment with IVT-AFL. Central retinal thickness was 440.8 ± 134.2 μm (mean ± SD) (n = 444) at baseline and 355.5 ± 126.4 μm (n = 140) at 24 months. Conclusion Routine administration of IVT-AFL for DME was not associated with new safety concerns, and BCVA outcomes were maintained over 24 months in the real-world setting. Nonetheless, patients in this real-world setting received fewer injections than those in clinical trials, suggesting that a margin for improvement exists in clinical practice. Trial registration ClinicalTrials.gov: NCT02425501.

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Section: Introductionmentioning

confidence: 99%

Intravitreal aflibercept for diabetic macular edema in real-world clinical practice in Japan: 24-month outcomes

Sugimoto

Handa

Hirano

et al. 2022

Graefes Arch Clin Exp Ophthalmol

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“…Ophthalmologists currently recognize that the intravitreal injection of anti-VEGF drugs is the first-line treatment for DME [ 10 , 11 ]. However, multiple injections are required to maintain therapeutic efficacy.…”

Section: Introductionmentioning

confidence: 99%

Regional Variety of Reduction in Retinal Thickness of Diabetic Macular Edema after Anti-VEGF Treatment

et al. 2022

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Background and Objectives: The presence of refractory cases resistant to anti-vascular endothelial growth factor (VEGF) therapy for diabetic macular edema (DME) is a problem in clinical practice. This study aimed to explore the less responsive area of optical coherence tomography (OCT) 3D map the characteristics of naïve DME cases after their first anti-VEGF. Materials and Methods: In 46 patients with DME who received an intravitreal injection of anti-VEGF agents, retinal thickness in 100 sections of the macular area was measured by 3D-mapping mode using OCT before and 1 month after injection. The density of the microaneurysm (MA) was calculated using merged images of the OCT map and fluorescein angiography. Results: One month after injection, the central retinal thickness significantly decreased (p < 0.0001). In severe edema (retinal thickness more than 500 µm), the area percentages with a reduction rate of the retinal thickness greater than 30% and less than 5% were 6.4 ± 6.6% and 10.1 ± 4.6%, respectively. The reduction rate of the retinal thickness varied from section to section. The mutual distance between the areas of maximum thickness before and after the injection averaged 1.22 ± 0.62 mm apart. The reduction rate of retinal thickness in the thickest region before injection was significantly higher (p = 0.02), and that in the thickest region after injection was lower (p = 0.001) than in the other regions. MA density in the residual edema was significantly higher than in the edema-absorbed area (p = 0.03). Conclusion: DME has areas that show low response to the reduction in retinal thickness with anti-VEGF therapy. A high density of MA may be associated with this pathogenesis.

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“…Current treatments for DME include focal laser photocoagulation, steroid injection, vitrectomy, and intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF). Anti-VEGF therapy is usually the first-line treatment for DME, and it greatly improves visual acuity [ 2 ]. A randomised clinical trial showed that best-corrected visual acuity (BCVA) improved by approximately 8–12 letters from baseline after 24 weeks of anti-VEGF therapy and that BCVA and central subfield thickness improved by 10.0–12.8 letters and 30.0–41.6%, respectively, after treatment with anti-VEGF and focal/grid laser at the 2-year visit [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

Evaluation of microaneurysms as predictors of therapeutic response to anti-VEGF therapy in patients with DME

et al. 2022

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Administration of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy is the first-line therapy for diabetic macular oedema (DME). However, some patients show no or insufficient response to repeated anti-VEGF injections. Therefore, it is necessary to identify factors that can predict this resistance against anti-VEGF treatment. Presence of microaneurysms (MAs) is a predictor of the development and progression of DME, but its relationship with the treatment response to the anti-VEGF agents is not well known. Therefore, we aimed to elucidate the relationship between the distribution of MAs and the response to anti-VEGF therapy in patients with DME. The number of MAs was measured before anti-VEGF therapy in each region using fluorescein angiography, indocyanine green angiography (IA), and optical coherence tomography angiography. Patients with DME were divided into the responder and non-responder groups after three loading phases. Differences in the distribution of MAs between the groups were investigated. Pre-treatment IA revealed more MAs in the nasal area in the non-responder group than in the responder group (10.7 ± 10.7 and 5.7 ± 5.7, respectively, in the nasal macula) (1.4 ± 2.1 and 0.4 ± 0.7, respectively, in the nasal fovea). Whereas, pre-treatment FA and OCTA could not reveal significantly difference between the groups. Detection of MAs in the nasal macula using pre-treatment IA may indicate resistance to anti-VEGF therapy. We recommend the clinicians confirm the presence of MAs in the nasal macula, as shown by IA, as a predictor of therapeutic response to anti-VEGF therapy in patients with treatment naive DME.

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Review of clinical studies and recommendation for a therapeutic flow chart for diabetic macular edema

Cited by 28 publications

References 109 publications

Intravitreal aflibercept for diabetic macular edema in real-world clinical practice in Japan: 24-month outcomes

Intravitreal aflibercept for diabetic macular edema in real-world clinical practice in Japan: 24-month outcomes

Regional Variety of Reduction in Retinal Thickness of Diabetic Macular Edema after Anti-VEGF Treatment

Evaluation of microaneurysms as predictors of therapeutic response to anti-VEGF therapy in patients with DME

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