التفاصيل البيبلوغرافية
| العنوان: |
Comparison of the efficacy and safety of SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration. |
| المؤلفون: |
Kang, Se Woong, Choi, Jaehwan, Sheth, Veeral S., Nowosielska, Agnieszka, Misiuk-Hojlo, Marta, Papp, András, Brown, David M., Lee, Jae-Ho, Barak, Yoreh |
| المصدر: |
Scientific Reports; 6/26/2024, Vol. 14 Issue 1, p1-9, 9p |
| مصطلحات موضوعية: |
MACULAR degeneration, AFLIBERCEPT, TREATMENT effectiveness, INTRAVITREAL injections, VISUAL acuity, ANTIBODY formation, SAFETY |
| مستخلص: |
To compare the efficacy and safety of the proposed aflibercept biosimilar SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration, this randomized, double-masked, parallel-group, multicenter study was conducted in 14 countries from 13 August 2020 to 8 September 2022. Patients with neovascular age-related macular degeneration. With subfoveal, juxtafoveal, or extrafoveal choroidal neovascularization were aged 50 years or older. Intravitreal injection of SCD411 or aflibercept (2.0 mg) were administered every 4 weeks for the first three injections and every 8 weeks until week 48. The primary efficacy endpoint was the change in best-corrected visual acuity from baseline to week 8 with an adjusted equivalence margin of ± 3.0 letters. Patients were randomly assigned to receive either SCD411 (n = 288) or reference aflibercept (n = 288). A total of 566 participants (98.3%) completed week 8 of the study. The least-squares mean difference of change in best-corrected visual acuity from baseline to week 8 (SCD411—aflibercept) was − 0.4 letters (90% confidence interval = − 1.6 to 0.9). The incidence of ocular (69 of 287 [24.0%] vs. 71 of 286 [24.8%]) and serious ocular (5 of 287 [1.7%] vs. 3 of 286 [1.0%]) treatment-emergent adverse effects were similar between the SCD411 and aflibercept groups. Immunogenicity analysis revealed a low incidence of neutralizing antibody formation in both groups. In conclusion, SCD411 has equivalent efficacy compared with reference aflibercept in patients with neovascular age-related macular degeneration and has a comparable safety profile. The results support the potential use of SCD411 for the treatment of neovascular age-related macular degeneration. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
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