A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)
3期
已完成
NCT05850520
| 适应症 | Macular Edema Secondary to Retinal Vein Occlusion |
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| 分期 | 3期 |
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| 申办方 | Bayer |
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| 状态 | 已完成 |
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| 受试者人数 | 892 人 |
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| 干预(药物) | Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose, Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg, Sham, Fluorescein |
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| 开始日期 | 2023年5月15日 |
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| 完成日期 | 2024年11月7日 |
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| 结果公布日 | 2025年12月18日 |
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摘要
Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO). In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema. When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry. The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease. Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While
Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 36
At Week 36 · Letters
| Aflibercept 2q4 | 17.5 ± 0.7 Letters |
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| Aflibercept 8q8/3 | 17.4 ± 0.7 Letters |
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| Aflibercept 8q8/5 | 18.3 ± 0.6 Letters |
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| p-value | <0.0001 |
| Difference in LS means | -0.1 (95% CI -2.0–1.9) |
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