Outcomes of a 2-year treat-and-extend regimen with aflibercept for diabetic macular edema

AbstractThis prospective, open-label, single-arm, non-randomized clinical trial, assessed the efficacy of a 2-year treat-and-extend (T&E) regimen involving intravitreal aflibercept injection (IAI), with the longest treatment interval set to 16 weeks, and adjunct focal/grid laser in diabetic macula edema (DME) patients. We examined 40 eyes (40 adults) with fovea-involving DME from 8 Japanese centers between April 2015 and February 2017. Participants received IAI with an induction period featuring monthly injections and a subsequent T&E period featuring 8–16-week injection interval, adjusted based on optical coherence tomography findings. The primary endpoints were mean changes in the best-corrected visual acuity (BCVA) and central subfield macular thickness (CST) from baseline. Thirty patients (75%) completed the 2-year follow-up. The mean BCVA and CST changed from 60.5 ± 15.6 letters and 499.2 ± 105.6 µm at baseline to 66.6 ± 17.1 letters (P = 0.217) and 315.2 ± 79.0 µm (P < 0.001), respectively, after 2 years. The treatment interval was extended to 12 and 16 weeks in 6.7% and 66.7% of patients, respectively, at the end of 2 years. The T&E aflibercept regimen with the longest treatment interval set to 16 weeks, with adjunct focal/grid laser may be a rational 2-year treatment strategy for DME.

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Two-year outcomes of intravitreal aflibercept in a Swiss routine treat and extend regimen for patients with neovascular age-related macular degeneration

Scientific Reports ◽

10.1038/s41598-020-76354-1 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Andreas Ebneter ◽

Stephan Michels ◽

Christian Pruente ◽

Pascal Imesch ◽

Felix Eilenberger ◽

...

Keyword(s):

Real Life ◽

Age Related Macular Degeneration ◽

Routine Practice ◽

Treat And Extend ◽

Treatment Interval ◽

Age Related ◽

Intravitreal Aflibercept ◽

Treatment Naïve ◽

The Mean ◽

Treat And Extend Regimen

AbstractThe aim of this observational study was to assess the use and outcome of intravitreal aflibercept in a treat and extend regimen in treatment-naïve neovascular AMD patients in routine practice. This both retrospective and prospective study was conducted in four larger Swiss retina clinics (ASTERIA study). The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in ETDRS letters from baseline to 12 months. Between December 2017 and August 2018, 160 patients were included. For patients with available data, the mean change in BCVA was + 8.4 (± 14.4) letters at month 12 (n = 139) and + 5.0 (± 11.4) letters at month 24 (n = 95). A mean number of 8.3 (± 2.4) injections were administered within the first year and 5.4 (± 2.9) injections during the second year. On average, the observed treatment interval at month 12 was 63.3 (± 22.0) days and increased to 69.1 (± 28.6) days at month 24. For 37% of the patients, a treatment interval ≥ 12 weeks was attained at month 24. In conclusion, intravitreal aflibercept in a Swiss real-life treat and extend regimen resulted in comparable anatomic and functional outcomes as were observed in the prospective registration trials of aflibercept for nAMD treatment.

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Two-year results of a treat and extend regimen with aflibercept in Caucasian patients with aneurysmal type 1 neovascularization

European Journal of Ophthalmology ◽

10.1177/11206721211001313 ◽

2021 ◽

pp. 112067212110013

Author(s):

Javier Montero Hernández ◽

Lidia Remolí Sargues ◽

Clara Monferrer Adsuara ◽

Verónica Castro Navarro ◽

Catalina Navarro Palop ◽

...

Keyword(s):

Pigment Epithelium ◽

First Year ◽

Regression Rate ◽

Treat And Extend ◽

Intravitreal Aflibercept ◽

Caucasian Patients ◽

The Mean ◽

Treat And Extend Regimen

Introduction: There are a few reports investigating the treatment of aneurysmal type 1 neovascularization (AT1) in Caucasian patients. The aim of this study is to evaluate the 2-year results of a treat and extend regimen with aflibercept in Caucasian patients with AT1. Methods: We conducted an observational retrospective study in 28 eyes of 26 patients with naïve AT1 treated with a treat an extend regimen of intravitreal aflibercept. Best corrected visual acuity (BCVA), central macular thickness (CMT), pigment epithelium detachment (PED) height, presence of dry macula, and regression rate of polypoidal lesions were assessed at baseline and at 12 and 24 months. Results: BCVA was significantly increased by 9.03 ± 16 letters ( p < 0.01) and 9.2 ± 16.87 letters ( p < 0.01) after the 12 and 24 months follow-up. A significant decrease of CMT was found at 12 and 24 months ( p < 0.01). Nevertheless, significant changes in PED height were not observed (0.1 < p > 0.05). At 12 and 24 months of follow-up, dry macula was achieved in a total of 10 eyes (35.71%) and 15 eyes (53.57%). The regression rate of polypoidal lesions was 25% (7 eyes) and 35.71% (10 eyes) after 12 and 24 months. The mean number of intravitreal injections was 7.81 ± 3.20 the first year and 6.11 ± 3.49 the second year. Conclusion: To the best of our knowledge, treat and extend regimen with intravitreal aflibercept in Caucasian patients may be effective for improving BCVA, CMT, wet macula, and regression rate of polypoidal lesions.

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Aflibercept in real-life for the treatment of age-related macular degeneration using a treat and extend protocol: The Armada study

European Journal of Ophthalmology ◽

10.1177/11206721211005703 ◽

2021 ◽

pp. 112067212110057

Author(s):

Pierre Gascon ◽

Prithvi Ramtohul ◽

Charles Delaporte ◽

Sébastien Kerever ◽

Danièle Denis ◽

...

Keyword(s):

Macular Degeneration ◽

Real Life ◽

Age Related Macular Degeneration ◽

Cumulative Number ◽

Treat And Extend ◽

Treatment Interval ◽

Age Related ◽

Treatment Naïve ◽

The Mean

Purpose: To report the visual and anatomic outcomes in treatment-naïve neovascular age-related macular degeneration (nAMD) patients treated with aflibercept under a standardized Treat and Extend (T&E) protocol for up to 3 years of follow-up in “real-life” practice. Methods: This retrospective, observational, multicenter study included patients with treatment-naïve nAMD and at least 12 months of follow-up. T&E regimen adjustment was initiated after loading phase. At each visit best-corrected visual acuity (BCVA) and optical coherence tomography parameters were performed. Results: One hundred and thirty-six eyes of 115patients had at least 1 year of follow-up with 114 and 82 eyes completing at least 2 and 3 years of follow-up, respectively (mean follow-up duration: 2.7 ± 1.3 years). Mean age was 78.6 ± 8.6 years old and 52% were women. Mean BCVA increased from 60.6 ± 18.7 letters at diagnosis to 66.9 ± 16.2 letters at 1 year (+6.3 letters, p = 0.003) and remained stable throughout the follow-up period (63.1 ± 20.3 letters (+2.5, p = 0.1) and 64.0 ± 20.1 letters (+3.4, p = 0.27) at 2 and 3 years, respectively). The mean central retinal thickness decreased significantly from 358.2 ± 87.9 µm at baseline to 302 ± 71.7 µm at 12 months and maintained stable after 36 months of follow-up (297.1 ± 76 µm, p < 0.0001). Mean number of injections was 6.6 ± 2.2, 4.8 ± 1.9, and 5.6 ± 1.7 at 1, 2, and 3 years, respectively. Mean cumulative number of 16.4 ± 5.6 injections after 3 years. Mean treatment interval was 6.8 ± 2.5 weeks at 1 year. Eight-week and 12-week treatment interval were achieved in 59.5% and 19.1%, 65.8%, and 36.8% and 69.5% and 41.5% at 1, 2, and 3 years, respectively. Conclusions: Our study demonstrated that intravitreal injections of aflibercept initiated under a standardized T&E for patients with treatment-naïve nAMD allow for significant visual improvement at 12 months, which was maintained over a 3-year follow-up period.

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Efficacy of Modified Treat-and-Extend Aflibercept Regimen for Macular Edema Due to Branch Retinal Vein Occlusion: 1-Year Prospective Study

Journal of Clinical Medicine ◽

10.3390/jcm9082360 ◽

2020 ◽

Vol 9 (8) ◽

pp. 2360

Author(s):

Yusuke Arai ◽

Hidenori Takahashi ◽

Satoru Inoda ◽

Shinichi Sakamoto ◽

Xue Tan ◽

...

Keyword(s):

Macular Edema ◽

Retinal Vein Occlusion ◽

Branch Retinal Vein Occlusion ◽

Treat And Extend ◽

Vein Occlusion ◽

Corrected Visual Acuity ◽

Intravitreal Aflibercept ◽

Central Subfield Thickness ◽

The Mean ◽

First Recurrence

Purpose: To assess the efficacy and safety of a modified treat-and-extend (mTAE) regimen of aflibercept for macular edema (ME) due to branch retinal vein occlusion (BRVO). Methods: This prospective multicentre intervention study evaluated 50 eyes of 50 patients enrolled from October 2016 to September 2017. The patients received intravitreal aflibercept (IVA) injections on an mTAE regimen for a total of 12 months. The main outcome measures were best-corrected visual acuity (BCVA) and central subfield thickness (CST) at 12 months. Results: The baseline BCVA and CST were 0.33 (0.27) and 488 (171) µm (mean (standard deviation)), respectively. The BCVA and CST were significantly improved at month 12 (0.067 (0.19) LogMAR and 295 (110) µm; both p < 0.0001, paired t-test). The mean number of clinic visits and IVA injections was 6.71 (1.41) and 4.26 (0.71), respectively. The time to first recurrence from the first injection was most frequently 3 months. Conclusion: The mTAE regimen of IVA injections for ME due to BRVO effectively improved BCVA and reduced CST, and thus might be an effective therapy to reduce the number of injections and visits.

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Comparison of outcomes between intravitreal ranibizumab and intravitreal aflibercept for diabetic macular edema with “Treat-and-Extend” regimen

10.21203/rs.2.21161/v1 ◽

2020 ◽

Author(s):

Masahiko Sugimoto ◽

Shinichiro Chujo ◽

Taku Sasaki ◽

Atsushi Ichio ◽

Ryohei Miyata ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Retinal Thickness ◽

Intravitreal Ranibizumab ◽

Treat And Extend ◽

Corrected Visual Acuity ◽

Anti Vegf ◽

Intravitreal Aflibercept ◽

Treatment Naïve ◽

Treat And Extend Regimen

Abstract 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 was a retrospective study of 125 eyes of 125 treatment naïve DME patients who received anti-VEGF injections at 3 consecutive monthly intervals as the loading phase. Of these 125 eyes, 26 eyes completed the treatment with the TAE regimen for at least 24 months. Among the 26 eyes, 13 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. The changes in the best-corrected visual acuity (BCVA), central retinal thickness (CRT), diabetic retinopathy severity (DRS), and total injection numbers were compared between the two anti-VEGF agents.Results No significant differences were detected in the baseline demographics. At 24 months, the 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=1.29x10 -9 ). The 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=3.55x10 -9 ). No significant differences were detected in the improvements of the BCVA and the CRT in both groups, and the total injection numbers were significant fewer for the IVA group (11.0±1.2) than the IVR group (12.0±1.0). The DRS 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 the BCVA or CRT and injection numbers between 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.

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Comparison of outcomes between intravitreal ranibizumab and intravitreal aflibercept for diabetic macular edema with “Treat-and-Extend” regimen

10.21203/rs.2.16775/v1 ◽

2019 ◽

Author(s):

Masahiko Sugimoto ◽

Shinichiro Chujo ◽

Taku Sasaki ◽

Atsushi Ichio ◽

Ryohei Miyata ◽

...

Keyword(s):

Visual Acuity ◽

Macular Edema ◽

Diabetic Macular Edema ◽

Intravitreal Ranibizumab ◽

Treat And Extend ◽

Corrected Visual Acuity ◽

Intravitreal Aflibercept ◽

Number Of Injections ◽

Best Corrected Visual Acuity ◽

Treat And Extend Regimen

Abstract Background To compare the effectiveness of intravitreal ranibizumab (IVR) and aflibercept (IVA) with the Treat-and-Extend (TAE) regimen for diabetic macular edema (DME).Patients and methods Thirteen eyes received an intravitreal injection of 0.5 mg ranibizumab (mean age, 70.9±6.0 years) and 13 eyes received 2 mg aflibercept (65.9±8.6 years). After 3 consecutive monthly injections, they received additional injections with the TAE regimen. The changes in the best-corrected visual acuity (BCVA), CRT, and total number of injections were compared.Results No significant differences were detected in the baseline demographics. The BCVA was significantly improved for both groups; 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 at 24 months ( P <0.01). The 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 at 24 months ( P <0.01). No significant differences were detected in the improvements of the BCVA and reduction in the CRT between them. The total number injections were significant fewer for the IVA group (11.0±1.2) than the IVR group (12.0±1.0) at 24 months ( P =0.02).Conclusion The results showed that the TAE regimen was effective. The IVA group required fewer injections to attain the same improvements.

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One-year Outcomes of a Treat-and-extend of Ranibizumab for Naive Exudative Age-related Macular Degeneration: Retrospective Analysis

Journal of the Korean Ophthalmological Society ◽

10.3341/jkos.2021.62.7.939 ◽

2021 ◽

Vol 62 (7) ◽

pp. 939-947

Author(s):

Young-Je Choi ◽

Woong-Sun Yoo ◽

Yong-Wun Cho ◽

Yu-Jin Choi ◽

In Young Chung

Keyword(s):

Visual Acuity ◽

Macular Degeneration ◽

Retinal Thickness ◽

Age Related Macular Degeneration ◽

Central Retinal Thickness ◽

Treat And Extend ◽

Corrected Visual Acuity ◽

Age Related ◽

The Mean ◽

Treat And Extend Regimen

Purpose: This study investigated the 1-year outcomes of a treat-and-extend regimen of ranibizumab for exudative age-related macular degeneration and examined the clinical results when drug treatment was changed within the same period. Methods: This retrospective analysis included 32 eyes first diagnosed with wet age-related macular degeneration and treated for more than 1 year with a treat-and-extend regimen of ranibizumab, as well as 24 eyes treated by changing from ranibizumab to aflibercept within the same period. The injection number, maximum injection interval, change in central retinal thickness, and best-corrected visual acuity were assessed in all eyes. Results: In 32 eyes that received a treat-and-extend regimen of ranibizumab, the mean best-corrected visual acuity improved from 59.46 ± 15.13 to 68.00 ± 12.48 at 12 months (p < 0.0001). The mean central retinal thickness decreased from 409 ± 141 μm to 273 ± 89 μm at 12 months (p < 0.0001). The average number of injections per year was 7.2 ± 0.85. One complication related to the 12 months of injections was a tear in the retinal pigment epithelium; no systemic complications were observed. Of 24 eyes that underwent a change in medication, the rate of maintenance or improvement in initial visual acuity was 83% (10 eyes). The central retinal thickness was initially 371.58 ± 109.96 μm, but improved to 290.33 ± 58.66 μm in 12 eyes that received three injections of aflibercept. Conclusions: At 1 year, good outcomes were obtained using treat-and-extend ranibizumab for exudative age-related macular degeneration. When the treatment was changed to aflibercept within the same period, vision was often maintained and short-term anatomical improvement was evident.

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Two-year outcomes of the treat-and-extend regimen using aflibercept for treating diabetic macular oedema

Scientific Reports ◽

10.1038/s41598-020-78954-3 ◽

2020 ◽

Vol 10 (1) ◽

Author(s):

Yu Cheol Kim ◽

Jae Pil Shin ◽

Kang Yeun Pak ◽

Hyun Woong Kim ◽

Min Sagong ◽

...

Keyword(s):

Macular Oedema ◽

Diabetic Macular Oedema ◽

Treat And Extend ◽

Scale Scores ◽

Dosing Regimens ◽

Injection Interval ◽

Flexible Dosing ◽

The Mean ◽

Number Of Injections ◽

Treat And Extend Regimen

AbstractThis study was performed to investigate the efficacy of the treat-and-extend regimen using aflibercept for treating diabetic macular oedema (DME). This prospective, multicentre, interventional, single-arm, 104-week clinical trial included 48 patients with DME visual impairment. The patients’ eyes received five consecutive intravitreal injections (2 mg aflibercept) every four weeks with two-week adjustments based on central subfield macular thickness (CSMT) changes. Injections were deferred when CSMT was stable. The number of injections, best-corrected visual acuity (BCVA), CSMT, and diabetic retinopathy severity scale scores were analysed. Compared to baseline, BCVA improved by + 9.1 letters at 52 weeks and was maintained with + 9.4-letter gain at 104 weeks (P < 0.001). Between baseline and 104 weeks, CSMT decreased from 489 to 298 μm (P < 0.001) and eyes with vision ≥ 20/40 increased from 17.4 to 43.5% (P = 0.007). The mean number of injections decreased from 8.5 in year one to 3.9 in year two. The injection interval was extended to ≥ 12 weeks in 56.5% of patients. The treat-and-extend regimen of aflibercept in DME showed 2-year efficacy comparable to that of fixed dosing regimens. The flexible dosing of this regimen reduced the number of injections in year two while maintaining efficacy.

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Efficacy of One-Year Treatment with Aflibercept for Diabetic Macular Edema with Practical Protocol

BioMed Research International ◽

10.1155/2017/7879691 ◽

2017 ◽

Vol 2017 ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

Tomomi Kaiho ◽

Toshiyuki Oshitari ◽

Tomoaki Tatsumi ◽

Yoko Takatsuna ◽

Miyuki Arai ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Serous Retinal Detachment ◽

Predictive Marker ◽

Photoreceptor Outer Segment ◽

Corrected Visual Acuity ◽

Intravitreal Aflibercept ◽

The Mean ◽

One Year

The purpose of this study was to determine the efficacy of one-year treatment of diabetic macular edema (DME) with intravitreal aflibercept (IVA) injections on a practical protocol. The medical records of 51 eyes of 43 patients who were diagnosed with DME and had received IVA treatments were reviewed. 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 IVA injections was 3.8±2.4. The mean BCVA was significantly better and the CMT was thinner after the IVA at all follow-up times (P<0.05). The BCVA was better in eyes with a serous retinal detachment (SRD) than without a SRD (P<0.01). There was a significant correlation between the photoreceptor outer segment (PROS) length and BCVA at the baseline and at 12 months after the IVA (P<0.05). A fewer number of IVA injections significantly improved the BCVA and the CMT in eyes with DME after one-year treatment. IVA was more effective in the SRD+ group than in the SRD− group. The PROS length may be a predictive marker for visual outcomes after one-year treatment with IVA for DME (IRB#2272).

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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

Journal of Clinical Medicine ◽

10.3390/jcm9092848 ◽

2020 ◽

Vol 9 (9) ◽

pp. 2848

Author(s):

Shinichiro Chujo ◽

Masahiko Sugimoto ◽

Taku Sasaki ◽

Yoshitsugu Matsui ◽

Kumiko Kato ◽

...

Keyword(s):

Macular Edema ◽

Diabetic Macular Edema ◽

Continuous Treatment ◽

Intravitreal Ranibizumab ◽

Treat And Extend ◽

Corrected Visual Acuity ◽

Anti Vegf ◽

Intravitreal Aflibercept ◽

Treatment Naïve ◽

Treat And Extend Regimen

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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