The article discusses the methodology of forming the teacher's readiness to use the electronic educational environment by immersion technology. The relevance of the study is determined by the ...challenges of our time. During the pandemic, all educational institutions of the Russian Federation had to switch to distance learning for students. Which presupposes possession of digital technologies by all participants in the educational process. To bridge the «digital divide» in the student-teacher relationship, a methodology has been developed to improve the qualifications of the teaching staff, which allows them to organize their professional activities using digital technologies. The leading method of researching this problem was a pedagogical experiment conducted among teachers and students, which made it possible to identify a positive trend in the willingness of teachers to use the capabilities of the University's electronic information and educational environment based on the results of the proposed methodology. The article clarifies the structure of a teacher's readiness to use the electronic information and educational environment of an educational organization, substantiates the effectiveness of the methodology for the formation of readiness using immersion technology.
During the COVID-19 pandemic, society has undergone significant changes with implications for employee values and job satisfaction. As a reflection of social needs, corporate social practice is also ...changing compared to before the pandemic. This paper examines the perception of corporate social practices by personnel and their impact on staff satisfaction. The empirical study carried out in the Russian Federation and the Republic of Kazakhstan allowed the authors to identify social practices that influence the level of personnel satisfaction with professional activity before and after the pandemic. The research determined general tendencies and differences in the perception of social practices with the most significant personnel satisfaction in the period before and after the pandemic. The authors also developed recommendations that should be taken into account when forming corporate social practices. The study’s novelty is the investigation of an empirical relationship between the levels of satisfaction with professional activity and implemented social practices in the period before and after the pandemic. The research found that the tendencies in Russia and Kazakhstan are similar to the global trends. Employees before the pandemic were highly satisfied with their activities and corporate social responsibility practices. After the pandemic, when society is disconnected and individualized, employees are focused on material security, and social practices have no significant influence on staff satisfaction. The paper offers recommendations for companies to implement appropriate social practices for the common interests of employers and staff.
Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. We report primary results of two phase 3 trials evaluating ...intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD).
TENAYA and LUCERNE were randomised, double-masked, non-inferiority trials across 271 sites worldwide. Treatment-naive patients with nAMD aged 50 years or older were randomly assigned (1:1) to intravitreal faricimab 6·0 mg up to every 16 weeks, based on protocol-defined disease activity assessments at weeks 20 and 24, or aflibercept 2·0 mg every 8 weeks. Randomisation was performed through an interactive voice or web-based response system using a stratified permuted block randomisation method. Patients, investigators, those assessing outcomes, and the funder were masked to group assignments. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48 (prespecified non-inferiority margin of four letters), in the intention-to-treat population. Safety analyses included patients who received at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (TENAYA NCT03823287 and LUCERNE NCT03823300).
Across the two trials, 1329 patients were randomly assigned between Feb 19 and Nov 19, 2019 (TENAYA n=334 faricimab and n=337 aflibercept), and between March 11 and Nov 1, 2019 (LUCERNE n=331 faricimab and n=327 aflibercept). BCVA change from baseline with faricimab was non-inferior to aflibercept in both TENAYA (adjusted mean change 5·8 letters 95% CI 4·6 to 7·1 and 5·1 letters 3·9 to 6·4; treatment difference 0·7 letters −1·1 to 2·5) and LUCERNE (6·6 letters 5·3 to 7·8 and 6·6 letters 5·3 to 7·8; treatment difference 0·0 letters –1·7 to 1·8). Rates of ocular adverse events were comparable between faricimab and aflibercept (TENAYA n=121 36·3% vs n=128 38·1%, and LUCERNE n=133 40·2% vs n=118 36·2%).
Visual benefits with faricimab given at up to 16-week intervals demonstrates its potential to meaningfully extend the time between treatments with sustained efficacy, thereby reducing treatment burden in patients with nAMD.
F Hoffmann-La Roche.
To reduce treatment burden and optimise patient outcomes in diabetic macular oedema, we present 1-year results from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial ...growth factor-A bispecific antibody.
YOSEMITE and RHINE were randomised, double-masked, non-inferiority trials across 353 sites worldwide. Adults with vision loss due to centre-involving diabetic macular oedema were randomly assigned (1:1:1) to intravitreal faricimab 6·0 mg every 8 weeks, faricimab 6·0 mg per personalised treatment interval (PTI), or aflibercept 2·0 mg every 8 weeks up to week 100. PTI dosing intervals were extended, maintained, or reduced (every 4 weeks up to every 16 weeks) based on disease activity at active dosing visits. The primary endpoint was mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56. Efficacy analyses included the intention-to-treat population (non-inferiority margin 4 Early Treatment Diabetic Retinopathy Study ETDRS letters); safety analyses included patients with at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (YOSEMITE NCT03622580 and RHINE NCT03622593).
3247 patients were screened for eligibility in YOSEMITE (n=1532) and RHINE (n=1715). After exclusions, 940 patients were enrolled into YOSEMITE between Sept 5, 2018, and Sept 19, 2019, and 951 patients were enrolled into RHINE between Oct 9, 2018, and Sept 20, 2019. These 1891 patients were randomly assigned to faricimab every 8 weeks (YOSEMITE n=315, RHINE n=317), faricimab PTI (n=313, n=319), or aflibercept every 8 weeks (n=312, n=315). Non-inferiority for the primary endpoint was achieved with faricimab every 8 weeks (adjusted mean vs aflibercept every 8 weeks in YOSEMITE 10·7 ETDRS letters 97·52% CI 9·4 to 12·0 vs 10·9 ETDRS letters 9·6 to 12·2, difference −0·2 ETDRS letters −2·0 to 1·6; RHINE 11·8 ETDRS letters 10·6 to 13·0 vs 10·3 ETDRS letters 9·1 to 11·4 letters, difference 1·5 ETDRS letters −0·1 to 3·2) and faricimab PTI (YOSEMITE 11·6 ETDRS letters 10·3 to 12·9, difference 0·7 ETDRS letters −1·1 to 2·5; RHINE 10·8 ETDRS letters 9·6 to 11·9, difference 0·5 ETDRS letters −1·1 to 2·1). Incidence of ocular adverse events was comparable between faricimab every 8 weeks (YOSEMITE n=98 31%, RHINE n=137 43%), faricimab PTI (n=106 34%, n=119 37%), and aflibercept every 8 weeks (n=102 33%, n=113 36%).
Robust vision gains and anatomical improvements with faricimab were achieved with adjustable dosing up to every 16 weeks, demonstrating the potential for faricimab to extend the durability of treatment for patients with diabetic macular oedema.
F Hoffmann-La Roche.
Purpose
This paper analyses the modern market for project finance, its sectorial structure and main development trends. This study aims to form a constructive diagnostic toolkit for investment ...support of infrastructure design in regions, taking into account spatial asymmetry in the context of an integrated management approach.
Design/methodology/approach
When analyzing the public–private partnership (PPP) project performance, it is reasonable to distinguish the following two levels of discount rates: state and private. To achieve a high level of development of the general infrastructure of a region, a conceptual approach to the formation of investment support for the development of regional infrastructure has been developed.
Findings
The scientific contribution of this study is to improve the approach to modeling investment support for regional infrastructure design in the context of spatial asymmetry. Implementation of infrastructure projects creates prerequisites for sustainable economic growth, improvement in business and investment and social attractiveness of the national economy and its regions.
Practical implications
The practical significance of this study is that its main provisions allow for an effective regional socio-economic policy, based on the systemic development of regional infrastructure and aim at boosting competitiveness.
Originality/value
Recommendations can be used by regional and local authorities to formulate a socio-economic strategy for regional development as well as by representatives of private business who intend to engage in regional PPP projects.
To evaluate the 2-year efficacy, durability, and safety of dual angiopoietin-2 and vascular endothelial growth factor (VEGF) A pathway inhibition with intravitreal faricimab according to a ...personalized treat-and-extend (T&E)-based regimen with up to every-16-week dosing in the YOSEMITE and RHINE (ClinicalTrials.gov identifiers, NCT03622580 and NCT03622593, respectively) phase 3 trials of diabetic macular edema (DME).
Randomized, double-masked, noninferiority phase 3 trials.
Adults with visual acuity loss (best-corrected visual acuity BCVA of 25-73 letters) due to center-involving DME.
Patients were randomized 1:1:1 to faricimab 6.0 mg every 8 weeks, faricimab 6.0 mg T&E (previously referred to as personalized treatment interval), or aflibercept 2.0 mg every 8 weeks. The T&E up to every-16-week dosing regimen was based on central subfield thickness (CST) and BCVA change.
Included changes from baseline in BCVA and CST, number of injections, durability, absence of fluid, and safety through week 100.
In YOSEMITE and RHINE (n = 940 and 951, respectively), noninferior year 1 visual acuity gains were maintained through year 2; mean BCVA change from baseline at 2 years (weeks 92, 96, and 100 average) with faricimab every 8 weeks (YOSEMITE and RHINE, +10.7 letters and +10.9 letters, respectively) or T&E (+10.7 letters and +10.1 letters, respectively) were comparable with aflibercept every 8 weeks (+11.4 letters and +9.4 letters, respectively). The median number of study drug injections was lower with faricimab T&E (YOSEMITE and RHINE, 10 and 11 injections, respectively) versus faricimab every 8 weeks (15 injections) and aflibercept every 8 weeks (14 injections) across both trials during the entire study. In the faricimab T&E arms, durability was improved further during year 2, with > 60% of patients receiving every-16-week dosing and approximately 80% receiving every-12-week or longer dosing at week 96. Almost 80% of patients who achieved every-16-week dosing at week 52 maintained every-16-week dosing without an interval reduction through week 96. Mean CST reductions were greater (YOSEMITE/RHINE weeks 92/96/100 average: faricimab every 8 weeks -216.0/-202.6 µm, faricimab T&E -204.5/-197.1 µm, aflibercept every 8 weeks -196.3/-185.6 µm), and more patients achieved absence of DME (CST < 325 μm; YOSEMITE/RHINE weeks 92-100: faricimab every 8 weeks 87%-92%/88%-93%, faricimab T&E 78%-86%/85%-88%, aflibercept every 8 weeks 77%-81%/80%-84%) and absence of intraretinal fluid (YOSEMITE/RHINE weeks 92-100: faricimab every 8 weeks 59%-63%/56%-62%, faricimab T&E 43%-48%/45%-52%, aflibercept every 8 weeks 33%-38%/39%-45%) with faricimab every 8 weeks or T&E versus aflibercept every 8 weeks through year 2. Overall, faricimab was well tolerated, with a safety profile comparable with that of aflibercept.
Clinically meaningful visual acuity gains from baseline, anatomic improvements, and extended durability with intravitreal faricimab up to every 16 weeks were maintained through year 2. Faricimab given as a personalized T&E-based dosing regimen supports the role of dual angiopoietin-2 and VEGF-A inhibition to promote vascular stability and to provide durable efficacy for patients with DME.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
TENAYA and LUCERNE Chen, Youxin; Heier, Jeffrey S.; Lin, Hugh ...
Ophthalmology,
August 2024, Volume:
131, Issue:
8
Journal Article
Peer reviewed
Open access
To evaluate 2-year efficacy, durability, and safety of the bispecific antibody faricimab, which inhibits both angiopoietin-2 and VEGF-A.
TENAYA (ClinicalTrials.gov identifier, NCT03823287) and ...LUCERNE (ClinicalTrials.gov identifier, NCT03823300) were identically designed, randomized, double-masked, active comparator-controlled phase 3 noninferiority trials.
Treatment-naive patients with neovascular age-related macular degeneration (nAMD) 50 years of age or older.
Patients were randomized (1:1) to intravitreal faricimab 6.0 mg up to every 16 weeks (Q16W) or aflibercept 2.0 mg every 8 weeks (Q8W). Faricimab fixed dosing based on protocol-defined disease activity at weeks 20 and 24 up to week 60, followed up to week 108 by a treat-and-extend personalized treatment interval regimen.
Efficacy analyses included change in best-corrected visual acuity (BCVA) from baseline at 2 years (averaged over weeks 104, 108, and 112) and proportion of patients receiving Q16W, every 12 weeks (Q12W), and Q8W dosing at week 112 in the intention-to-treat population. Safety analyses included ocular adverse events (AEs) in the study eye through study end at week 112.
Of 1326 patients treated across TENAYA/LUCERNE, 1113 (83.9%) completed treatment (n = 555 faricimab; n = 558 aflibercept). The BCVA change from baseline at 2 years was comparable between faricimab and aflibercept groups in TENAYA (adjusted mean change, +3.7 letters 95% confidence interval (CI), +2.1 to +5.4 and +3.3 letters 95% CI, +1.7 to +4.9, respectively; mean difference, +0.4 letters 95% CI, −1.9 to +2.8) and LUCERNE (adjusted mean change, +5.0 letters 95% CI, +3.4 to +6.6 and +5.2 letters 95% CI, +3.6 to +6.8, respectively; mean difference, −0.2 letters 95% CI, −2.4 to +2.1). At week 112 in TENAYA and LUCERNE, 59.0% and 66.9%, respectively, achieved Q16W faricimab dosing, increasing from year 1, and 74.1% and 81.2%, achieved Q12W or longer dosing. Ocular AEs in the study eye were comparable between faricimab and aflibercept groups in TENAYA (55.0% and 56.5% of patients, respectively) and LUCERNE (52.9% and 47.5% of patients, respectively) through week 112.
Treat-and-extend faricimab treatment based on nAMD disease activity maintained vision gains through year 2, with most patients achieving extended dosing intervals.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
To evaluate the 2-year efficacy, durability, and safety of dual angiopoietin-2 and vascular endothelial growth factor (VEGF) A pathway inhibition with intravitreal faricimab according to a ...personalized treat-and-extend (T&E)-based regimen with up to every-16-week dosing in the YOSEMITE and RHINE (ClinicalTrials.gov identifiers, NCT03622580 and NCT03622593, respectively) phase 3 trials of diabetic macular edema (DME).
Randomized, double-masked, noninferiority phase 3 trials.
Adults with visual acuity loss (best-corrected visual acuity BCVA of 25–73 letters) due to center-involving DME.
Patients were randomized 1:1:1 to faricimab 6.0 mg every 8 weeks, faricimab 6.0 mg T&E (previously referred to as personalized treatment interval), or aflibercept 2.0 mg every 8 weeks. The T&E up to every-16-week dosing regimen was based on central subfield thickness (CST) and BCVA change.
Included changes from baseline in BCVA and CST, number of injections, durability, absence of fluid, and safety through week 100.
In YOSEMITE and RHINE (n = 940 and 951, respectively), noninferior year 1 visual acuity gains were maintained through year 2; mean BCVA change from baseline at 2 years (weeks 92, 96, and 100 average) with faricimab every 8 weeks (YOSEMITE and RHINE, +10.7 letters and +10.9 letters, respectively) or T&E (+10.7 letters and +10.1 letters, respectively) were comparable with aflibercept every 8 weeks (+11.4 letters and +9.4 letters, respectively). The median number of study drug injections was lower with faricimab T&E (YOSEMITE and RHINE, 10 and 11 injections, respectively) versus faricimab every 8 weeks (15 injections) and aflibercept every 8 weeks (14 injections) across both trials during the entire study. In the faricimab T&E arms, durability was improved further during year 2, with > 60% of patients receiving every-16-week dosing and approximately 80% receiving every-12-week or longer dosing at week 96. Almost 80% of patients who achieved every-16-week dosing at week 52 maintained every-16-week dosing without an interval reduction through week 96. Mean CST reductions were greater (YOSEMITE/RHINE weeks 92/96/100 average: faricimab every 8 weeks –216.0/–202.6 µm, faricimab T&E –204.5/–197.1 µm, aflibercept every 8 weeks –196.3/–185.6 µm), and more patients achieved absence of DME (CST < 325 μm; YOSEMITE/RHINE weeks 92–100: faricimab every 8 weeks 87%–92%/88%–93%, faricimab T&E 78%–86%/85%–88%, aflibercept every 8 weeks 77%–81%/80%–84%) and absence of intraretinal fluid (YOSEMITE/RHINE weeks 92–100: faricimab every 8 weeks 59%–63%/56%–62%, faricimab T&E 43%–48%/45%–52%, aflibercept every 8 weeks 33%–38%/39%–45%) with faricimab every 8 weeks or T&E versus aflibercept every 8 weeks through year 2. Overall, faricimab was well tolerated, with a safety profile comparable with that of aflibercept.
Clinically meaningful visual acuity gains from baseline, anatomic improvements, and extended durability with intravitreal faricimab up to every 16 weeks were maintained through year 2. Faricimab given as a personalized T&E-based dosing regimen supports the role of dual angiopoietin-2 and VEGF-A inhibition to promote vascular stability and to provide durable efficacy for patients with DME.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
PDF
