BENITIONSClinical Trial Intelligence

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
分期3期
申办方Bayer
状态已完成
受试者人数892 人
干预(药物)Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose, Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_2 mg, Sham, Fluorescein
开始日期2023年5月15日
完成日期2024年11月7日
结果公布日2025年12月18日

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 2q417.5 ± 0.7 Letters
Aflibercept 8q8/317.4 ± 0.7 Letters
Aflibercept 8q8/518.3 ± 0.6 Letters
p-value<0.0001
Difference in LS means-0.1 (95% CI -2.0–1.9)

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