2024-512298-28-00招募中4 期
A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects with Neovascular Age-Related Macular Degeneration (nAMD)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 20
- 主要终点
- Annualized intravitreal anti-VEGF injection rate from Week 6 through Week 54.
研究概览
简要总结
To evaluate anti-VEGF injection burden and long-term efficacy after subretinal surabgene lomparvovec administration, compared to PRN intravitreal ranibizumab given per protocol specified criteria during Year 1, and subsequently compared to a PRN intravitreal ranibizumab schedule that mimics the real-world clinic setting after Year 1.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 [Week –6]) in the study eye
- •Must have a diagnosis of CNV secondary to AMD in the study eye
- •Must have received at least 2 intravitreal anti-VEGF injections in the past 6 months in the study eye prior to Screening Visit 1 (Week –6) and have been responsive (determined by investigator)
排除标准
- •CNV or macular edema in the study eye that is secondary to any causes other than AMD.
- •Study eye with nAMD diagnosed > 4 years from Screening Visit 1
- •Any subretinal hemorrhage in the study eye > 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center.
- •History of retinal detachment, retinal tear or macular hole in the study eye that, in the opinion of the investigator, may preclude successful subretinal injection of surabgene lomparvovec.
结局指标
主要结局
Annualized intravitreal anti-VEGF injection rate from Week 6 through Week 54.
Annualized intravitreal anti-VEGF injection rate from Week 6 through Week 54.
次要结局
- Change from Baseline in BCVA at Year 3.
- Annualized intravitreal anti-VEGF injection rate from Week 6 through Year 3.
- Incidence and severity of ocular AEs in the study eye and contralateral eye
- Change from Baseline in area of macular atrophy based on FAF at assessed time points in the study eye
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (20)
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