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Purpose: To compare 1-year outcomes of eyes with diabetic macular edema (DME) treated in routine clinical practice based on the proportion of visits where intravitreal VEGF inhibitor injections were delivered., Design: Cohort study., Participants: There were 2288 treatment-naive eyes with DME starting intravitreal VEGF inhibitor therapy from October 31, 2015 to October 31, 2021 from the Fight Retinal Blindness! international outcomes registry., Methods: Eyes were grouped according to the proportion of visits at which an injection was received, Group A with less than the median of 67% (n = 1172) versus Group B with greater than the median (n = 1116)., Main Outcome Measures: Mean visual acuity (VA) change after 12 months of treatment., Results: The mean (95% confidence interval [CI]) VA change after 12 months of treatment was 3.6 (2.8-4.4) letters for eyes in Group A versus 5.2 (4.4-5.9) letters for eyes in Group B (P = 0.005). The mean (95% CI) central subfield thickness (CST) change was -69 (-76 to -61) μm and -85 (-92 to -78) μm for eyes in Group A versus Group B, respectively (P = 0.002). A moderate positive correlation was observed between the number of injections received over 12 months of treatment and the change in VA (P < 0.001). Additionally, eyes that received more injections had a moderately greater CST reduction., Conclusions: This registry analysis found that overall VA and anatomic outcomes tended to be better in DME eyes treated at a greater proportion of visits in the first year of intravitreal VEGF inhibitor therapy., Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article., (Copyright © 2024 American Academy of Ophthalmology. All rights reserved.)

There remains limited agreement regarding the efficacy and safety of different antivascular endothelial growth factor (anti-VEGF) agents for the management of polypoidal choroidal vasculopathy (PCV). Our meta-analysis compares different anti-VEGF agents for PCV treatment. Ovid MEDLINE, EMBASE, and Cochrane Library were systematically searched from January 2000 to July 2022. We included articles comparing the efficacy and safety of different anti-VEGF agents, specifically bevacizumab (BEV), ranibizumab (RAN), aflibercept AFL), and brolucizumab (BRO), for patients with PCV. 10,440 studies were identified, 122 underwent full-text review, and seven were included. One study was a randomized trial, and six were observational studies. Ranibizumab and aflibercept were associated with a similar best-corrected visual acuity (BCVA) at the last visit in three observational studies (P = 0.10), similar retinal thickness at the last visit in two observational studies (P = 0.85). One observational study comparing BEV versus RAN found comparable outcomes for final BCVA, retinal thickness, and polyp regression. One randomized trial on BRO versus AFL found comparable outcomes for improvement in BCVA, while anatomical outcomes favored BRO. The available evidence suggests that final BCVA is comparable across different anti-VEGF agents, however, further investigation is warranted due to paucity of evidence., Competing Interests: Declaration of Competing Interest MMP: Financial support (to institution)—PSI Foundation and Fighting Blindness Canada. RHM: Advisory board—Alcon, Bausch + Lomb, Bayer, Novartis, Allergan, and Roche; Financial Support (to institution)—Bayer, Novartis, and Roche. PJK: Advisory board—Novartis, Alcon, Bayer, Roche, Allergan, and Novelty Nobility; Financial support (to institution)—Bayer, Roche, and Novartis; Financial support—Novartis, Bayer, Roche, Boehringer Ingelheim, Pfizer, and Zeiss; Equity owner—ArcticDx. DTW: Consultant—AbbVie, Alcon, Apellis, Bayer, Bausch Health, Biogen, Boehringer Ingelheim, Novartis, Ripple Therapeutics, Roche, Topcon, and Zeiss. Research grants from Novartis and Roche., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Introduction: The Canadian Treat-and-Extend Analysis Trial with Ranibizumab (CANTREAT) was a 2-year, multicentred, randomized clinical trial to evaluate treat-and-extend (T&E) relative to monthly administration of ranibizumab in neovascular age-related macular degeneration (nAMD). This post hoc analysis of the CANTREAT trial explores the relationship between the maximal extension interval tolerated by patients receiving T&E ranibizumab and visual acuity outcomes., Methods: Treatment-naïve patients with nAMD were randomized to receive either a once-monthly dosing or T&E regimen of ranibizumab across 27 treatment centres in Canada and were followed for 24 months. For this post hoc analysis, patients in the T&E cohort were subdivided into the following groups based on maximum extension interval: 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 weeks. The primary outcome was the change in ETDRS best-corrected visual acuity (BCVA) from baseline to month 24 while secondary outcomes included change in central retinal thickness (CRT). All results were reported using descriptive statistics., Results: A total of 285 participants undergoing T&E were enrolled in this post hoc analysis. At month 24, the change in BCVA from baseline was +8.5 ± 9.3, +7.7 ± 13.8, +4.4 ± 9.6, +4.4 ± 18.5, and +7.8 ± 14.8 letters in the 4-, 6-, 8-, 10-, and 12-week cohorts, respectively. The change in CRT at month 24 was -79.2 ± 95.0, -143.9 ± 128.9, -97.7 ± 101.1, -120.9 ± 105.3, and -133.2 ± 108.8 μm in the 4-, 6-, 8-, 10-, and 12-week cohorts, respectively., Conclusion: The capacity to extend does not necessarily associate with improved visual acuity outcomes, with the poorest change in BCVA seen in those extended 8-10 weeks. The highest change in BCVA and lowest decrease in CRT was in the group maximally extended for 4 weeks. There was a correlation between change in BCVA and change in CRT for other extension groups. Future studies should establish the predictive factors for successful extension in patients undergoing T&E in nAMD., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Purpose: To assess the effect of fluid status at baseline (BL) and at the end of the loading phase (LP) of three different ranibizumab regimens: treat-and-extend (T&E), fixed bimonthly (FBM) injections and pro re nata (PRN), in patients with neovascular age-related macular degeneration (nAMD)., Design: Post hoc analysis of the In-Eye study (phase IV clinical trial)., Methods: Patients were randomized 1:1:1 to the three study arms and were treated accordingly. The presence and type of fluid, intraretinal fluid (IRF) or subretinal fluid (SRF) and the anatomical and visual outcomes were analysed., Main Outcome Measures: Best-corrected visual acuity (BCVA), the mean change from baseline BCVA (BL BCVA), and the proportion of eyes gaining more than 15 letters or losing more than five letters were analysed. Morphological characteristics including the subtype of choroidal neovascular membrane and the development of atrophy and fibrosis were also evaluated., Results: Patients with SRF at LP had better visual outcomes than patients with IRF. The persistence of SRF did not affect the mean change from BL BCVA among the three treatment regimens. However, in patients with IRF mean change from BL BCVA was significantly lower in the FBM group. The presence of IRF at BL and at the end of the loading phase was associated with the development of fibrosis at the end of the study; this result was contrary to that observed for patients with SRF., Conclusions: While SRF is compatible with good visual and anatomical outcomes, IRF leads to worse results in patients with nAMD; our results suggest that patients with IRF have better outcomes when individualized treatment regimens are used (PRN or T&E) in contrast with a FBM regimen., (© 2021 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Purpose: To assess the noninferiority of the treat-and-extend (T&E) and fixed bimonthly regimens of 0.5 mg intravitreal ranibizumab as compared with the pro re nata (PRN) in naïve patients with neovascular age-related macular degeneration (nAMD)., Methods: Phase IV, randomized, 12-month, multicentre trial. Patients aged ≥50 years with nAMD and visual impairment [best-corrected visual acuity (BCVA) between 23 and 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] were eligible. Patients (one eye per patient) were randomized to bimonthly, n = 103, T&E, n = 99 or PRN, n = 104. Noninferiority was established at five letters ETDRS., Results: The mean (95% CI) difference in BCVA at 12 months was 7.2 (4.2-10.2), 6.4 (2.9-9.8), and 8.0 (51.1-11.0) in the bimonthly, T&E and PRN, respectively. The bimonthly or T&E regimens were not inferior to the PRN scheme. All regimens were associated with a significant reduction of central subfield thickness and volume. The mean (95% CI) number of injections in the bimonthly regimen (7.6, 7.5-7.7) was similar as compared with the PRN regimen (7.4, 6.7-8.0) (p = 0.159) but lower than in the T&E regimen (9.3, 8.9-9.7) (p < 0.001)., Conclusion: At 12 months, bimonthly and T&E ranibizumab were noninferior to PRN in naïve nAMD., (© 2020 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Purpose : To investigate outcomes associated with switching from pro re nata (PRN) to treat-and-extend (TAE) anti-vascular endothelial growth factor (VEGF) regimen in patients with type 3 neovascularization. Methods : This retrospective study included 17 eyes diagnosed with type 3 neovascularization. All eyes underwent monthly anti-VEGF injections as the initial treatment for 3 months, followed by PRN-based retreatment. During the course of treatment, the strategy was changed to that of a TAE regimen. Best-corrected visual acuity (BCVA) measurements were compared across the three time points: After the loading injection, after the PRN phase, and after the TAE phase. Results : After the loading injection, the eyes were treated for 16.2 ± 5.5 months using the PRN regimen with 5.1 ± 1.5 anti-VEGF injections. After switching to the TAE regimen, 7.5 ± 3.0 injections were administered over 20.5 ± 8.2 months. The mean logarithm of the minimum angle of resolution BCVA was 0.44 ± 0.30 (Snellen equivalents = 20/55) after three loading injections, 0.58 ± 0.32 (20/76) after the PRN phase, and 0.62 ± 0.33 (20/83) after the TAE phase. The BCVA after the PRN phase was significantly deteriorated as compared to that after the three loading injections ( P = .015), whereas the BCVA values were not different after the TAE and PRN phases ( P = .342). Conclusions : In type 3 neovascularization, visual acuity was maintained for an average of 20.5 months after switching from the PRN regimen to the TAE regimen. Further studies with larger study populations and controlled study designs are required to confirm our findings.

Purpose: To evaluate treatment outcome at 12 months in eyes with neovascular age-related macular degeneration (nAMD) treated with antivascular endothelial growth factor (anti-VEGF) injections according to either pro re nata (PRN)- or treat-and-extend (TE)-regimen in one clinical setting in Sweden., Methods: Data were obtained retrospectively from the Swedish Macula Register, optical coherence tomography-database and electronic patient charts. The study included 443 eyes; 223 PRN- and 220 TE-treated eyes. Baseline (BL) characteristics and follow-up data at 6 and 12 months were collected. Statistical regression analysis was performed to evaluate association between treatment strategy and visual outcome at 12 months., Results: Baseline (BL) characteristics were well balanced between cohorts. Visual acuity at 12 months was higher in TE-cohort 66.5 (13.1) compared to PRN-cohort 60.1 (17.6) (p = 0.000). Visual improvement at 12 months was +5.2 (11.8) and +1.2 (12.7) letters Early Treatment Diabetic Retinopathy Study (ETDRS) in TE- and PRN-cohorts, respectively (p = 0.002). Number of administered injections at 12 months was 10.2 (2.1) and 6.3 (2.1) in the two cohorts (p = 0.000). Statistical analysis demonstrated a strong association between TE treatment strategy and improvement in visual acuity at 12 months., Conclusion: Eyes treated according to TE had better visual outcome at 12 months. The results indicate that treatment according to proactive TE-regimen is superior to treatment according to PRN-regimen in clinical routine care of nAMD., (© 2018 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Background: Our purpose was to evaluate the relationship between subfoveal choroidal thickness (SCT) and development of macular atrophy (MA) in eyes with age-related macular degeneration (AMD)., Methods: This was a prospective, multicenter study. Sixty participants (120 eyes) in the TREX-AMD trial (NCT01648292) with treatment-naïve neovascular AMD (NVAMD) in at least one eye were included. SCT was measured by certified reading center graders at baseline using spectral domain optical coherence tomography (SDOCT). The baseline SCT was correlated with the presence of MA at baseline and development of incident MA by month 18. Generalized estimating equations were used to account for information from both eyes., Results: Baseline SCT in eyes with MA was statistically significantly less than in those without MA in both the dry AMD (DAMD) (P = 0.04) and NVAMD (P = 0.01) groups. Comparison of baseline SCT between MA developers and non-MA developers revealed a statistically significant difference (P = 0.03). Receiver operating characteristic curve (ROC) analysis showed the cut-off threshold of SCT for predicting the development of MA in cases without MA at baseline was 124 μm (AUC = 0.772; Sensitivity = 0.923; Specificity = 0.5). Among eyes without MA at baseline, those with baseline SCT ≤124 μm were 4.3 times more likely to develop MA (Odds ratio: 4.3, 95% confidence interval: 1.6-12, P = 0.005) than those with baseline SCT >124 μm., Conclusions: Eyes with AMD and MA had less SCT than those without MA. Eyes with less baseline SCT also appear to be at higher risk to develop MA within 18 months.

Purpose: In several case-studies improved outcomes have been reported after switching from a pro-re-nata (PRN)- to a treat-and-extend (T&E)-based therapeutic approach in cases of neovascular age-related macular degeneration (nAMD). We therefore wished to compare the effects of instigating 2 different protocols in newly-diagnosed nAMD undergoing treatment with Ranibizumab., Methods: The outcomes of a PRN- and a T&E-based regime were retrospectively compared in treatment-naïve eyes under therapy with Ranibizumab for minimally 12 months in a routine clinical setting. The primary outcome measures included the proportion of the eyes with intraretinal fluid in OCT and visual stability after the initial drug-loading phase., Results: The comparative case-series included 107 eyes (PRN: 68; T&E: 39). During the 2-year follow-up period, a similar number of clinical examinations were performed in the 2 groups (PRN: 14.0 ± 6.2; T&E 13.4 ± 4.4; P = 0.97), whereas the number of injections that were administered differed for the first (PRN: 5.5 ± 2.0 vs. T&E 6.8 ± 2.4; P = 0.008) and the second year (PRN: 1.9 ± 2.0 vs. T&E 3.8 ± 2.3; P = 0.002). The proportion of eyes with intraretinal fluid after the initial drug-loading phase remained stable (PRN: from 33.8% to 36.4%; T&E: from 25.6% to 29.0%); so, too, did the central retinal thickness and the visual acuity., Conclusion: Despite a limited sample size, this retrospective analysis revealed the anatomical and the functional improvements during the 2-year follow-up period to be not roughly different for the 2 strategies. However, when the PRN-approach is instigated, the risk of under-treatment due to lapses in visits or to over-extensions in the intervals between treatments may be underestimated.

Purpose: To investigate long-term visual results of treatment with anti-vascular endothelial growth factor (VEGF) agents for neovascular age-related macular degeneration (nAMD) following a treat-and-extend regimen., Methods: Retrospective review of 155 patients who initiated treatment with bevacizumab for nAMD in one eye. At the final 8-year visit, 40 patients (26%) remained for follow-up. Mean change in best-corrected visual acuity (BCVA) was calculated compared to baseline values., Results: Mean BCVA improved significantly from baseline during the first year of treatment, with -0.11 logMAR units equivalent to 6.1 approximate Early Treatment Diabetic Retinopathy Study (approxETDRS) letters (p = <0.001). Mean BCVA was still significantly improved after 4 years of treatment for the entire group of patients and after 6 years of treatment for the subgroup of 40 patients who remained at the final 8-year visit. Thereafter, BCVA gradually declined and at 8 years, there was a mean change of 0.05 logMAR units equivalent to 2.1 approxETDRS letters below baseline (p = 0.530). Mean number of injections during the first year was 6.1 ± 2.8 and during year 8 was 5.4 ± 3.5. At 5 years, fundus autofluorescence showed some degree of macular atrophy in all eyes. At the final 8-year visit, 87.5% of the eyes had stable neovascular lesions with no fluid on optical coherence tomography (OCT)., Conclusion: In an everyday clinical setting, treatment of nAMD patients with a treat-and-extend modality provided improvement and stability of vision for several years. After 8 years of follow-up, there was a decline in visual acuity (VA) that could be explained by macular atrophic development., (© 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Purpose: To evaluate the visual outcome after transitioning from a pro re nata (PRN) intravitreal injection regimen to a treat-and-extend (TAE) regimen for patients with neovascular age-related macular degeneration (AMD)., Methods: A retrospective review of patients who were switched from a PRN regimen with intravitreal injections of bevacizumab, ranibizumab or aflibercept to a TAE regimen. The best corrected visual acuity (BCVA), central retinal thickness (CRT) and type of medication used at baseline, at the time of changing treatment regimen and at the end of the study were analysed., Results: Twenty-one eyes of 21 patients met the inclusion criteria. Prior to the switch, the patients received a mean of 13.8 injections (median, 10; range, 3-39 injections) with the PRN regimen for 44 months (range, 3-100 months), which improved the visual acuity in five patients (24%). After a mean of 6.1 injections (median, 5; range, 3-14 injections) with the TAE regimen over 8 months (range, 2-16 months), the visual acuity improved in 12 patients (57%). The improvement in visual acuity during treatment with the TAE regimen was statistically significant (p = 0.005). The proportion of patients with a visual acuity of 0.2 or better was significantly higher after treatment with the TAE regimen than after treatment with the PRN regimen (p = 0.048). No significant differences in CRT were found between the two treatment regimens., Conclusion: Even after prolonged treatment and a high number of intravitreal injections, switching AMD patients from a PRN regimen to a strict TAE regimen significantly improves visual acuity., (© 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Purpose. To evaluate long-term results of anti-VEGF therapy performed in a modified “treat-and-extend” regimen in macular edema secondary to central retinal vein occlusion.Material and methods. The prospective study included 29 patients (16 men and 13 women) aged 24–81. The median follow-up period was 36 months [24; 60]. 20 patients underwent ranibizumab monotherapy, 3 patients – aflibercept monotherapy, while 6 patients received a combination of the two drugs following the modified regimen, which allowed terminating anti-VEGF treatment when macular edema remission was achieved.Results. Macular edema completely resolved in 27 out of 29 patients (93.1%) by the end of the second year, while the remaining 2 patients showed the complete resolution during the third year. 18 patients (62.1%) could terminate anti-VEGF therapy during the first 6 months, whereupon they received 3 to 5 monthly injections with no macular edema relapse over the subsequent 21–22 months of the follow-up. 11 patients continued anti-VEGF therapy and averagely received 7.09 ± 1.14, 5.09 ± 2.34 and 2.18 ± 2.36 injections with individually determined intervals at years 1, 2 and 3, respectively. On the whole, 22 patients (75.9%) terminated anti-VEGF therapy and transferred to drugless observation at the end of year 2, while 5 other patients (17.2%) terminated anti-VEGF therapy during year 3. As a result of the treatment, the maximum BCVA improved from 0.15 [0.07; 0.3] to 0.7 [0.4; 0.9] by the end of year 1 (Z = -4.69; p = 0.0000027) and remained stable during the rest of the follow-up.Conclusion. Anti-VEGF therapy in modified treat-and-extend regimen is effective in macular edema secondary to central retinal vein occlusion. and results in a significant and sustainable visual acuity gain and complete resolution of macular edema with a minimum quantity of injections in most patients.

Intravitreal injections (IVI) of anti-vascular endothelial growth factor (anti-VEGF) have become the standard of care for age-related macular degeneration (AMD). Although most pivotal trials have used monthly injections, alternative strategies that enable the injections to be administered on a more flexible schedule, including pro re nata (PRN) and treat-and-extend (T&E) regimens, are being applied more frequently. This review sought to provide further scientific evidence about the visual outcomes and treatment burden among the currently available anti-VEGF agents and regimens, including aflibercept, ranibizumab, abicipar and brolucizumab. To this end, a systematic review of published randomized studies was conducted from the MEDLINE and EMBASE databases and the Cochrane library, and a meta-analysis was applied to the obtained data using single-means modeling to compare the efficacy and maintenance among the different available treatments and regimens at Years 1 and 2. Quality analysis identified the best-informed data for modeling purposes. Overall, 47 relevant publications were retrieved for the analysis. Superior efficacy, meaning that there were observed improvements in visual acuity (VA) and central retinal thickness (CRT), occurred with monthly versus PRN regimens, yet a higher IVI number was also observed. Conversely, the T&E regimens displayed similar efficacy to the monthly regimens, but with a reduced IVI number. Aflibercept T&E exhibited similar efficacy to ranibizumab T&E, but with significantly lower IVI numbers at both Year 1 (p < 0.0001) and Year 2 (p = 0.0011). Though all of the regimens resulted in maintained efficacy between Years 1 and 2, the required IVI number varied. The retrieved data did not enable other regimens or newer anti-VEGF agents such as brolucizumab to be compared. In conclusion, the T&E regimens were shown to be the most efficient, optimizing durable effectiveness whilst minimizing the IVI number in newly diagnosed exudative AMD, with aflibercept requiring the lowest IVI number. [ABSTRACT FROM AUTHOR]

Purpose. To evaluate the economic and clinical results of the aflibercept and ranibizumab angiogenesis inhibitors in the treat-and-extend regimen in patients with the “wet” form of age-related macular degeneration (wAMD). Materials and methods. We analyzed cost minimization, impact on the budget and “missed opportunities” for the treatment of patients with wAMD using intravitreal injections (IVI) of aflibercept compared to ranibizumab in the “treat-and-extend” regimen (T & E). Costs were calculated with regard to the budget of the system of compulsory health insurance. To calculate the number of IVI, network meta-analysis data (P. Lanzetta, et al., 2019), including a matching-adjusted indirect comparison of aflibercept and ranibizumab in wAMD patients in the T & E regimen, were taken into account. The budget impact analysis involved a cohort of 1,000 wAMD patients. To assess the stability of the results, a one-factor multicomponent sensitivity analysis was used. Results. Network meta-analysis data showed that aflibercept and ranibizumab used in the T & E regimen revealed comparable changes in the maximum corrected visual acuity; however, the use of aflibercept required a significantly lower (by 6 procedures in two years) number of IVI compared to ranibizumab. Analysis of cost minimization showed that the use of aflibercept can reduce costs by 36 % in two years compared to ranibizumab in the T & E regimen. The use of aflibercept in the T & E regimen with wAMD will reduce the cost of compulsory medical insurance by 281 million rubles in two years of therapy per 1,000 patients. The analysis of “missed opportunities” showed that budget savings of the compulsory medical insurance as a result of transferring 1,000 patients from ranibizumab to aflibercept will allow an additional 563 patients to be treated in two years. A sensitivity analysis confirmed the robustness of the study results. Conclusion. Treating wAMD with aflibercept in the T & E regimen saves a significant part of health protection resources compared to using ranibizumab in the same regimen.

Purpose: To assess disease stability (absence of intra- and/or subretinal fluid) and the portion of eyes being capable to extend their treatment interval to ≥ 12 weeks in exudative age-related macular degeneration (AMD). Methods: A systematic literature search was performed in NCBI, PubMed, CENTRAL, and ClinicalTrials.gov to identify clinical studies reporting treatment outcomes for ranibizumab, aflibercept, and brolucizumab in exudative AMD under a treat-and-extend protocol and a follow-up of ≥ 12 months. Weighted mean differences and subgroup comparisons were used to integrate the different studies. Results: This meta-analysis refers to 29 published series, including 27 independent samples and 5629 patients. In the pooled group, disease stability was reported in 62.9% and 56.0%, respectively, after 12 and 24 months of treatment, whereas treatment intervals were extended to ≥ 12 weeks in 37.7% and 42.6%, respectively. Ranibizumab, aflibercept, and brolucizumab differed regarding their potential to achieve disease stability (56.3%, 64.5%, and 71.5% after 12, and 50.0%, 52.7% and 75.7% after 24 months; p = < 0.001) and to allow an interval extension to ≥ 12 weeks (28.6%, 34.2%, and 53.3% after 12, and 34.2%, 47.7%, and 41.7% after 24 months; p = < 0.001). Conclusion: The portion of eyes achieving disease stability regressed in the second year, whereas the portion of eyes under a ≥ 12-week interval increased. This discrepancy may reflect the challenges in balancing between under-treatment and a reduced treatment burden. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: To compare the 1‐year outcomes of treat‐and‐extend (TAE) and every‐other‐month (2M) regimens with intravitreal aflibercept in Japanese wet age‐related macular degeneration (AMD) patients. Methods: Prospective, multicenter, randomized clinical trial. The primary outcome measure was the proportion of eyes in which the best‐corrected visual acuity (BCVA) was maintained at week 52 [with a loss of <0.3 logarithm of minimum angular of resolution (logMAR) units]. The secondary outcome measures were the mean change from baseline in the central retinal thickness (CRT) and the number of injections. Results: Forty‐one patients were enrolled. The mean changes in the BCVA from baseline in the TAE and 2M were −0.32 ± 0.27 and −0.26 ± 0.30 logMAR units (p = 0.46). The TAE group was noninferior to the 2M group in BCVA maintenance. The mean CRT changes from baseline in the TAE and 2M were −161 ± 133 and −157 ± 90 μm (p = 0.73). The mean number of injections in the TAE and 2M were 7.5 ± 1.2 (range, 7–12) and 8.0 ± 0.0 (p < 0.0001). Conclusion: Treat‐and‐extend (TAE) regimen with aflibercept improved the BCVA and CRT to the same extent as 2M regimen, with a reduced number of injections. [ABSTRACT FROM AUTHOR]