Clinical preferences and trends of anti‐vascular endothelial growth factor treatments for diabetic macular edema in Japan

Sugimoto, Masahiko; Tsukitome, Hideyuki; Okamoto, Fumiki; Oshika, Tetsuro; Ueda, Takahiro; Niki, Masanori; Mitamura, Yoshinori; Ishikawa, Hiroto; Gomi, Fumi; Kitano, Shigehiko; Noma, Hidetaka; Shimura, Masahiko; Sonoda, Shozo; Sawada, Osamu; Ohji, Masahito; Harimoto, Kozo; Takeuchi, Masaru; Takamura, Yoshihiro; Kondo, Mineo; Sakamoto, Taiji

doi:10.1111/jdi.12929

“…Although the trend appears to be not using antibiotics before or after IVI, in some geographic areas, including Japan, topical antibiotics are still used routinely. In a survey of Japanese ophthalmologists, 97.2% of respondents used antibiotics before and/or after IVI, whereas only 2.8% reported not using topical antibiotic eye drops 10 . The Japanese Retina and Vitreous Society states the choice to use antibiotics related to IVI is at the discretion of ophthalmologists 11 .…”

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confidence: 99%

Incidence of endophthalmitis after intravitreal injection of an anti-VEGF agent with or without topical antibiotics

Morioka

¹

,

Takamura

²

,

Nagai

³

et al. 2020

Sci Rep

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Intravitreal injection (IVI) of anti-vascular endothelial growth factor (VEGF) is the standard treatment modality in various types of retinal diseases. However, endophthalmitis remains the most serious complication. Despite the lack of evidence that antibiotics prevent endophthalmitis, topical antibiotics are still used routinely in Japan. We conducted a retrospective multicenter study by analyzing records from patients who underwent IVI of anti-VEGF agents with or without antibiotic treatment. In the analysis of a total of 147,440 eyes, the incidence of endophthalmitis was 0.007%: 0.005% with no use of antibiotics, 0.009% with antibiotic pretreatment, 0.012% with posttreatment, and 0.005% with pre- and posttreatment. There was no statistically significant difference among the four groups (chi-square test, p = 0.57). Most facilities used masks, sterilized gloves, and drapes. Nine of the 10 eyes that developed endophthalmitis received topical antibiotics, and all infected eyes underwent IVI with aflibercept, not the prefilled syringe delivery system. In four patients who received multiple IVI, the detection of causative bacteria revealed resistance to used antibiotics. Data from this large population, treated with or without antibiotics, suggests that antibiotic prophylaxis does not reduce the rate of endophthalmitis after IVI.

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“…The medical records of 95 eyes of 71 cases that were diagnosed with DME and had received the first IVA injection at the Chiba University Hospital from January in 2015 to December in 2017 were reviewed. The inclusion criteria were patients with DME who had a vision impairment and a CMT > 250 μ m based on the optical coherence tomographic images (SD-OCT, Heidelberg Engineering, Heidelberg, Germany) [ 19 , 20 , 24 ]. The recent Japanese survey indicates that most ophthalmologists in Japan think OCT findings including CMTs as one of the most important indicators for initial therapeutic intervention [ 24 ].…”

Section: Methodsmentioning

confidence: 99%

Comparisons of One to Three Monthly Injections of Aflibercept for Diabetic Macular Edema by Practical Protocol

Hayashi

¹

,

Tatsumi

²

,

Oshitari

³

et al. 2021

Journal of Diabetes Research

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The purpose of this study was to compare the efficacies of one initial intravitreal injection of aflibercept followed by a pro re nata (PRN; 1+PRN) regimen to those of three consecutive monthly injections followed by the PRN (3+PRN) regimen for diabetic macular edema (DME) with practical protocols. The medical records of 95 eyes of 71 cases that were diagnosed with DME and had received intravitreal aflibercept (IVA) injections were reviewed. Fifty-seven eyes had received IVA with the 1+PRN regimen, and 38 eyes had received IVA with the 3+PRN regimen. The best-corrected visual acuity (BCVA) and the central macular thickness (CMT) were measured at the baseline and at 1, 3, 6, and 12 months after the IVA. The mean number of injections of the 1+PRN group was 2.9 ± 1.7 , which was significantly fewer than that of the 3+PRN group at 4.6 ± 1.4 ( P < 0.001 ). The change of the mean BCVA before and after the IVA at 12 months of the 3+PRN group was − 0.14 ± 0.17 logMAR units which was significantly better than that of the 1+PRN group of − 0.045 ± 0.25 logMAR units ( P = 0.02 ). The change of the CMT before and after the IVA at 6 months of the 3+PRN group was − 141.3 ± 152.4 μ m which was significantly more than that of the 1+PRN group at − 86.1 ± 117.8 μ m ( P = 0.013 ). Although the mean number of injections was more than that in the 1+PRN regimen, the 3+PRN regimen had better visual outcomes at 12 months. In a practical protocol, we recommend the 3+PRN regimen for patients with DME (IRB#3541).

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“…Among them, treatment as needed, or the pro re nata (PRN) regimen, is frequently used. In fact, 75.0% of Japanese ophthalmologists prefer the PRN regimen for DME during the maintenance phase [ 9 ]. However, the PRN regimen is inconvenient because it requires frequent visits to determine the status of DME.…”

Section: Introductionmentioning

confidence: 99%

Comparison of 2-Year Outcomes between Intravitreal Ranibizumab and Intravitreal Aflibercept for Diabetic Macular Edema with “Treat-and-Extend” Regimen—Its Usefulness and Problems

Chujo

¹

,

Sugimoto

²

,

Sasaki

³

et al. 2020

JCM

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Background: To compare the effectiveness of intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) performed with the treat-and-extend (TAE) regimen on eyes with diabetic macular edema (DME). Patients and methods: This is a retrospective study of 125 eyes of 125 treatment-naïve DME patients who received anti-VEGF injections at three consecutive monthly intervals as the loading phase. The changes in the best-corrected visual acuity (BCVA), central retinal thickness (CRT), diabetic retinopathy severity scale (DRSS), and total injection numbers were compared between the two anti-VEGF agents. Results: Among 125 eyes, 26 eyes completed the treatment with the TAE regimen for 24 months (20.8%). Thirteen eyes of 13 patients (mean age, 70.9 ± 6.0 years) received intravitreal injections of 0.5 mg ranibizumab, and 13 eyes of 13 patients (65.9 ± 8.6 years) received 2 mg aflibercept. No significant differences were detected in the baseline demographics. At 24 months, BCVA was significantly improved in both groups; from 0.31 ± 0.19 to 0.10 ± 0.12 logMAR units for IVR and 0.41 ± 0.19 to 0.16 ± 0.28 logMAR units for IVA (p = 1.29 × 10−9). CRT was significantly reduced in both groups; 440.9 ± 69.3 to 307.5 ± 66.4 μm for IVR and 473.9 ± 71.5 to 317.8 ± 71.2 μm for IVA (p = 3.55 × 10−9). No significant differences were detected in the improvements of BCVA, CRT in both groups, and the total injection numbers for 24 months (11.0 ± 1.2 for the IVA group and 12.0 ± 1.0 the IVR group). DRSS was significantly improved in both groups (p = 0.0004 for IVR and p = 0.009 for IVA). Conclusion: No significant differences were detected in the improvements of BCVA or CRT and injection numbers between the IVR and IVA groups treated with the TAE regimen. These results indicate that the results of the treatment with both agents with the TAE regimen were equally effective, but only 20.8% of patients completed 24 months of continuous treatment with the TAE regimen. Synopsis: There are no significant differences regarding effectiveness between the IVR and IVA groups treated with the TAE regimen for DME eyes.

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Clinical preferences and trends of anti‐vascular endothelial growth factor treatments for diabetic macular edema in Japan

Cited by 49 publications

References 33 publications

Incidence of endophthalmitis after intravitreal injection of an anti-VEGF agent with or without topical antibiotics

Incidence of endophthalmitis after intravitreal injection of an anti-VEGF agent with or without topical antibiotics

Comparisons of One to Three Monthly Injections of Aflibercept for Diabetic Macular Edema by Practical Protocol

Comparison of 2-Year Outcomes between Intravitreal Ranibizumab and Intravitreal Aflibercept for Diabetic Macular Edema with “Treat-and-Extend” Regimen—Its Usefulness and Problems

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