Two-year outcomes of the treat-and-extend regimen using aflibercept for treating diabetic macular oedema
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ABSTRACT:
SUBMITTER: Kim Y
PROVIDER: S-EPMC7745011 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
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Project description:This 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.
| S-EPMC7904904 | biostudies-literature
Project description:AimsTo demonstrate non-inferiority of ranibizumab treat-and-extend (T&E) with/without laser to ranibizumab pro re nata (PRN) for best-corrected visual acuity (BCVA) in patients with diabetic macular oedema (DMO).MethodsA 24-month single-masked study with patients randomised 1:1:1 to T&E+laser (n=121), T&E (n=128) or PRN (control; n=123). All patients received monthly injections until BCVA stabilisation. The investigator decided on re-treatment in the PRN and treatment-interval adaptations in the T&E groups based on loss of BCVA stability due to DMO activity. Likewise, laser treatment was at investigator's discretion. Collectively, these features reflect a real-life scenario. Endpoints included mean average change in BCVA from baseline to months 1-12 (primary), mean BCVA change from baseline to months 12 and 24, treatment exposure and safety profile.ResultsBoth T&E regimens were non-inferior to PRN based on mean average BCVA change from baseline to months 1-12 (T&E+laser: +5.9 and T&E: +6.1 vs PRN: +6.2 letters; both p<0.0001). Mean BCVA change at month 24 was similar across groups (+8.3, +6.5 and +8.1 letters, respectively). The mean number of injections was 12.4 and 12.8 in the T&E+laser and T&E groups and 10.7 in the PRN group. The T&E regimens showed 46% reduction in the number of clinic visits. Over 70% of patients maintained their BCVA, with treatment intervals of ≥2 months over 24 months. Safety profile was consistent with that described in the product information.ConclusionsT&E is a feasible treatment option for patients with DMO, with a potential to reduce treatment burden. Slightly more injections were required versus PRN, likely due to the specifics of the T&E regimen applied here.Trial registration numberNCT01171976.
| S-EPMC4893084 | biostudies-literature
Project description:The purpose of this study was to compare the efficacy of intravitreal aflibercept versus ranibizumab for treating therapy-resistant diabetic macular oedema (DME). A 69-year-old man presented with persistent bilateral DME despite previous ranibizumab treatment. Bilateral study treatment comprised one cycle of three monthly ranibizumab injections (0.5 mg), followed by one cycle of three aflibercept injections (2.0 mg), a second ranibizumab cycle and a second aflibercept cycle. Baseline visual acuity (ETDRS score) was 60 letters for the right eye and 65 letters for the left eye. Baseline central foveal thickness (CFT) was 305 ?m for the right eye and 453 ?m for the left eye. Substantially improved outcomes were observed during the first aflibercept cycle. CFT was reduced by 150 ?m (mean) in both the eyes and decreased below the lowest level achieved during the previous 2.5-year ranibizumab treatment. Visual acuity was improved by 17.5 letters (mean) in both the eyes. Reintroduction of ranibizumab immediately worsened the status of both eyes back to the baseline level. During the final aflibercept cycle, visual acuity and CFT improved to the same levels achieved during the first aflibercept cycle. In this case study, we prospectively switched the treatment three times and observed a dramatic and consistent treatment advantage for aflibercept.
| S-EPMC4488481 | biostudies-literature
Project description:This prospective, multicentre, interventional study evaluated the efficacy of a modified treat-and-extend (mTAE) aflibercept regimen as personalized therapy for macular oedema (MO) due to central retinal vein occlusion (CRVO). Fifty eyes were studied from 50 patients who were enrolled between November 2016 and July 2019. All patients received intravitreal aflibercept (IVA) injections on an mTAE regimen for 24 months. Primary outcome measures were best-corrected visual acuity (BCVA) and central subfield thickness (CST) at 12 months. Secondary endpoints were BCVA and CST at 24 months. Mean (standard deviation) baseline BCVA (logMAR) and CST were 0.50 (0.51) and 557 (240) µm, respectively. BCVA and CST showed significant improvements at month 12 (0.19 (0.38) and 275 (98) µm, respectively; both p < 0.0001, paired t-test). BCVA and CST also showed significant improvements at 24 months (0.26 (0.50) and 255 (91) µm, respectively, p = 0.0004 and p < 0.0001, paired t-test). The mean numbers of IVA injections and clinic visits over the 24-month study period were 6.2 (3.0) and 10.3 (1.0), respectively. The mTAE regimen of IVA injections for MO due to CRVO was effective in improving BCVA and decreasing CST at 24 months. The mTAE regimen might be an effective personalized therapy for CRVO.
| S-EPMC10419814 | biostudies-literature
Project description:This study aimed to evaluate the long-term (24-month) efficacy and safety of a modified treat-and-extend (mTAE) regimen of aflibercept for macular edema (ME) due to branch retinal vein occlusion (BRVO). This was a prospective multicenter intervention study. We evaluated 50 eyes in 50 patients with ME due to BRVO enrolled between October 2016 and September 2017. The patients received intravitreal aflibercept (IVA) injections according to a mTAE regimen for 24 months. This study reports the secondary endpoints of best-corrected visual acuity (BCVA) and central subfield thickness (CST) at 24 months and compares them with previously reported primary endpoints. Compared with baseline BCVA and CST of 0.33 (0.27) and 488 (165) µm (mean (standard deviation)), respectively, BCVA and CST were significantly improved at 12 and 24 months (12 months: 0.059 (0.19) LogMAR and 299 (112) µm; 24 months: 0.034 (0.18) LogMAR and 272 (81) µm, respectively; both p < 0.0001). Over the 24-month period, the mean number of IVA injections and clinic visits was 7.4 (3.3) and 11.1 (2.0), respectively. The mTAE regimen of IVA injections for ME due to BRVO was effective for improving BCVA and reducing CST over 24 months. This regimen shows promise for reducing the number of injections and clinic visits.
| S-EPMC8307685 | biostudies-literature
Project description:The 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.
| S-EPMC7680100 | biostudies-literature
Project description: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). 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. 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. 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.
| S-EPMC7464624 | biostudies-literature
Project description:PurposeTo evaluate the efficacy of intravitreal aflibercept as a second-line therapy in eyes with persistent diabetic macular oedema (DMO) despite receiving initial bevacizumab treatment.MethodsA prospective multicentre study was conducted in nine academic clinics in Israel. Starting from the first follow-up visit, a treat-and-extend regimen was applied in which the treatment intervals were extended by 2 weeks based on macular thickness using SD-OCT. The primary outcome was central subfield thickness (CST) at week 52.ResultsForty-four patients (n = 48 eyes) were recruited to the study, and 43 eyes completed 52 weeks of follow-up. Patients received a mean (±SD) of 7.9 ± 3.5 bevacizumab injections before enrolment. The mean (±SD) CST under aflibercept therapy decreased from 468 ± 131 μm at baseline to 303 ± 67 μm at 52 weeks (p = 0.002), and best corrected visual acuity improved from 64 ± 15 ETDRS letters at baseline to 75 ± 8 letters at week 52 (p = 0.001). Twenty (46%) eyes met the treat-and-extend criteria and received a mean (±SD) of 10.9 ± 2 aflibercept injections.ConclusionsEyes with persistent DMO following initial bevacizumab therapy had a marked reduction in macular thickness and improved visual acuity following 1 year of treatment with intravitreal aflibercept. Less than half of the patients met eligibility criteria for extension of the treatment interval; for these patients, the treat-and-extend regimen resulted in a maximum treatment interval of 10 weeks during the first year.
| S-EPMC8027790 | biostudies-literature
Project description:PurposeThe purpose of the study was to investigate longer term functional and morphological outcomes and their predictors in diabetic macular edema (DME) following a treat-and-extend regimen (TER) without loading dose under ranibizumab.MethodsPatient data were reviewed and analyzed retrospectively over a period of 24 months after initiation of TER. Best-corrected visual acuity (BCVA), treatment frequency, and quantitative and qualitative spectral-domain optical coherence tomography parameters were assessed.Results118 eyes of 87 patients were included. A mean of 9.74 ± 2.13 injections in the first and 7.63 ± 2.29 in the second year were applied. There were significant gains of BCVA and reductions in central retinal thickness from baseline to 12 and 24 months (all p < 0.001). Percentage of eyes with an intact inner segment/outer segment (IS/OS) junction increased from 15.3% at baseline to 42.1% at 24 months (p < 0.001). An intact IS/OS junction at baseline increased the probability of having a dry retina after 12 months by 79.3% (p = 0.017) and after 24 months by 88.1% (p = 0.040). Less IS/OS disruption at baseline predicted longer maximum recurrence-free treatment intervals at 2 years (r = -0.345, p < 0.001) and better BCVA at 1 year (r = -0.347, p < 0.001). Baseline bigger intraretinal cysts were associated with more IS/OS disruption at 24 months (r = 0.305, p = 0.007). Younger age and lower BCVA at baseline were predictive for a higher BCVA gain at 24 months (p = 0.046, p < 0.001).ConclusionRanibizumab applied in a TER without loading dose in DME significantly improves visual acuity and retinal anatomical structure throughout 2 years. The evaluated predictors might help guide routine clinical treatment in DME.
| S-EPMC8259065 | biostudies-literature
Project description:PurposeRadiation retinopathy (RR)-related macular edema commonly causes poor visual acuity outcomes in patients previously treated with ocular radiation therapy. Current treatments are not US Food and Drug Administration (FDA)-approved and prior studies have variable outcomes. We performed a multicenter, prospective, randomized clinical trial to assess the safety and efficacy of 2 mg intravitreal aflibercept injections (IAIs) for the treatment of RR.MethodsThirty-nine eyes in 39 patients with RR-related macular edema causing vision loss were assigned randomly to cohorts (1:1 ratio) in which patients either did or did not receive a loading dose of 3 IAIs followed by a treat-and-extend regimen. The primary outcome measure was the mean Early Treatment Diabetic Retinopathy Study best-corrected visual acuity (BCVA) change from baseline.ResultsOf the 39 randomized patients, 30 (76.9%) completed the year 1 follow-up visit. The overall mean BCVA change from baseline was 4.3 letters (P = 0.087), with 1.57 letters and 6.69 letters gained in cohorts 1 and 2, respectively (P = 0.31). There was a significant difference in central retinal thickness (CRT) from baseline to week 52 overall (484.4 µm to 326.5 µm) and within cohorts 1 (441.2 µm to 311.1 µm) and 2 (522.3 µm to 339.9 µm), respectively (P < 0.001). A total of 96.7% of the patients had visual acuity of 20/200 or better, and 30.0% improved 10 or more letters.ConclusionsAflibercept may improve CRT and may prevent vision loss in patients with RR using a treat-and-extend regimen through 52 weeks of therapy. Larger, multicenter studies are needed to confirm these findings.
| S-EPMC10292667 | biostudies-literature