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, Shinichiro; Sugimoto, Masahiko; Sasaki, Taku; Matsui, Yoshitsugu; Kato, Kumiko; Ichio, Atsushi; Miyata, Ryohei; Matsubara, Hisashi; Kondo, Mineo

doi:10.3390/jcm9092848

Cited by 11 publications

(17 citation statements)

References 32 publications

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Section: Resultsmentioning

confidence: 99%

“…For aflibercept, 4 studies reported injection frequency at the 12-month follow-up (range: 2.9 35 to 6.5 42 ). The cumulative mean number of injections was 4.6 (4 studies with 5 treatment arms).…”

Section: Resultsmentioning

confidence: 99%

“…The cumulative mean number of injections was 4.6 (4 studies with 5 treatment arms). One study each reported mean number of injections for aflibercept 1 dose at baseline (AFL 1q4w) followed by PRN regimen (2.9), 35 aflibercept 3 monthly doses (AFL 3q4w) followed by T&E regimen (6.5), 42 and AFL 3q4w followed by PRN regimen (4.6) 35 ( Figure S5 ).…”

Section: Resultsmentioning

confidence: 99%

“…The mean number of injections for ranibizumab 1 dose at baseline (RAN 1q4w) followed by an as-needed approach (pro re nata [PRN]) ranged from 3.9 37 to 4.4, 29 and the mean number of injections for ranibizumab 3q4w (RAN 3q4w) followed by PRN regimen ranged from 4.3 41 to 7.2. 36 Only 1 study reported the mean number of injections for RAN 3q4w followed by treat and extend (T&E) regimen (7.1) 42 at the 12-month follow-up (Figure S4). Notes: Data reported for number of studies is not mutually exclusive, because some studies reported data for more than one anti-VEGF and one study (Hayashi 2021 35 ) reported data for both loading and no loading regimen.…”

Section: Mean Number Of Injectionsmentioning

confidence: 99%

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Real-World Evidence in the Management of Diabetic Macular Edema with Intravitreal Anti-VEGFs in Asia: A Systematic Literature Review

Yuen¹,

Tan²,

Gan³

et al. 2022

OPTH

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Purpose To evaluate the visual outcomes and safety profile of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy in the treatment of diabetic macular edema (DME) in real-world studies in Asian countries. Methods A systematic review of electronic literature databases (Embase, Medline, and the Cochrane Library from January 1, 2010, to March 16, 2021) was conducted to identify observational studies that reported clinical and safety outcomes of anti-VEGF treatments for DME in Asia. We analyzed baseline patient characteristics, treatment patterns, mean number of injections, best-corrected visual acuity (BCVA), retinal thickness, and safety outcomes. Results Seventy-one studies were included in this review. Most studies reported treatment of DME with ranibizumab (n = 33), followed by aflibercept (n = 13), bevacizumab (n = 28), and conbercept (n = 9). At 12 months, the cumulative mean number of injections for ranibizumab, aflibercept, and conbercept was 5.2, 4.6, and 6, respectively. At the 12-month follow-up, the cumulative mean BCVA gain was 6.8 letters (ranibizumab), 4.6 letters (aflibercept), 4.9 letters (bevacizumab), and 8.3 letters (conbercept). The cumulative mean reduction in retinal thickness at 12 months was 116.9 μm (ranibizumab), 105.9 μm (aflibercept), 81.7 μm (bevacizumab), and 135.2 μm (conbercept). A strong positive correlation (r = 0.78) was observed between mean number of injections and change in BCVA at 12 months. A moderate positive correlation (r = 0.54) was observed between mean number of injections and mean reduction in retinal thickness at 12 months. A weak positive correlation was observed between baseline retinal thickness and visual acuity at 12 months. Baseline BCVA and mean number of injections were predictors of BCVA at 12 months. Conclusion All anti-VEGFs were effective in the treatment of DME in Asia. The data suggest that a greater number of anti-VEGF injections was associated with better improvement in BCVA and moderate reduction in retinal thickness at the 1-year follow-up.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Mean Number Of Injectionsmentioning

confidence: 99%

See 2 more Smart Citations

Real-World Evidence in the Management of Diabetic Macular Edema with Intravitreal Anti-VEGFs in Asia: A Systematic Literature Review

Yuen¹,

Tan²,

Gan³

et al. 2022

OPTH

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“…An OCT-guided treat-and-extend management protocol was used during this study, similar in design to what has been widely adopted in the real world. 5 , 6 In short, patients underwent monthly (28–34 days) anti-VEGF treatments until all identifiable retinal edema had resolved on OCT. Once the retinal edema had resolved, patients were extended out to 1–2 week increments until recurrence of the retinal edema was observed, and the interval of treatment was then adjusted to maintain a macula that was fluid-free. For the purpose of this study, patients were considered treatment-resistant whenever a fluid-free macula on OCT could not be accomplished in spite of more than or equal to six anti-VEGF treatments over a 12-month period.…”

Section: Methodsmentioning

confidence: 99%

Faricimab for Treatment-Resistant Diabetic Macular Edema

Rush¹,

Rush²

2022

OPTH

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To assess the short-term outcomes in treatment-resistant diabetic macular edema (DME) patients changed from intravitreal aflibercept (IVA) to intravitreal faricimab (IVF). Methods: A retrospective review was undertaken on DME subjects receiving IVA therapy at a single private practice. Patients were separated into study and control cohorts. Both study and control patients had received more than or equal to six IVA injections during the preceding 12 months, more than or equal to four IVA injections during the preceding 6 months, had a central macular thickness (CMT) on optical coherence tomography (OCT) of ≥300 µm, and had retinal fluid on OCT before cohort assignment. Study patients were switched to IVF and underwent three injections within 4 months, whereas control patients stayed on IVA during the same period and received three injections within 4 months. Results: There were 51 patients analyzed. There were 37.5% (9/24) in the study group and 3.7% (1/27) in the control group who achieved a CMT of less than 300 µm without retinal fluid on OCT at the end of the 4-month study (p=0.001). There were 41.7% (10/24) in the study group and 11.1% (3/27) in the control group who had gained two or more lines of visual acuity at the end of the 4-month study (p=0.01). Conclusion: For a significant minority, IVF can improve the short-term visual and anatomic outcomes in treatment-resistant DME patients formerly managed with IVA. Longer follow-up is needed to determine if such improvements can be preserved.

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

Cited by 11 publications

References 32 publications

Real-World Evidence in the Management of Diabetic Macular Edema with Intravitreal Anti-VEGFs in Asia: A Systematic Literature Review

Real-World Evidence in the Management of Diabetic Macular Edema with Intravitreal Anti-VEGFs in Asia: A Systematic Literature Review

Faricimab for Treatment-Resistant Diabetic Macular Edema

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

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