A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Participants With Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 116
- 试验地点
- 26
- 主要终点
- To evaluate the long-term safety of RGX-314
研究概览
简要总结
This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of ABBV-RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for up to 5 years after ABBV-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following ABBV-RGX-314 administration in the parent study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must provide written, signed informed consent for this study.
- •Must have been enrolled in a previous clinical study of ABBV-RGX-314 in the treatment of nAMD and must have received an SCS injection of ABBV-RGX-314 in that study.
- •Must be willing and able to comply with all study procedures.
排除标准
- 未提供
研究组 & 干预措施
Supplemental Treatment
DL 4 participants from the parent study will be able to receive supplement ranibizumab based on protocol-specified criteria if they develop worsening nAMD activity.
干预措施: Ranibizumab (Drug)
Standard of Care
Dose Level (DL) 1-3 participants who received ABBV-RGX- 314 in the parent study will continue to receive standard of care for the study duration.
干预措施: Standard of Care (Drug)
Supplemental Treatment
DL 4 participants from the parent study will be able to receive supplement ranibizumab based on protocol-specified criteria if they develop worsening nAMD activity.
干预措施: Standard of Care (Drug)
结局指标
主要结局
To evaluate the long-term safety of RGX-314
时间窗: 5 years inclusive of parent study
Incidences of ocular Adverse Events and Serious Adverse Events, and all Adverse Events of Special Interest
Incidences of ocular Adverse Events and any Serious Adverse Events
时间窗: 5 years inclusive of parent study
To evaluate the long-term safety of ABBV-RGX-314
次要结局
- • To evaluate the persistence of effect of RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT)(5 years inclusive of parent study)
- • To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA)(5 years inclusive of parent study)
- • To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy(5 years inclusive of parent study)
- • To assess the need of clinic visits for management of nAMD(5 years inclusive of parent study)
- Incidences of non-ocular Adverse Events and any Adverse Events of Special Interest(5 years inclusive of parent study)
- Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA based on ETDRS score in the study eye at assessed timepoints(5 years inclusive of parent study)
- Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CRT as measured by SD-OCT in the study eye at assessed timepoints(5 years inclusive of parent study)
- Mean number of supplemental anti-VEGF injections through years 2, 3, 4 and 5(5 years inclusive of parent study)
- Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5(5 years inclusive of parent study)
- Mean supplemental anti-VEGF injection annualized rate through years 2, 3, 4, and 5(5 years inclusive of parent study)
- Mean supplemental anti-VEGF injection annualized rate in years 2, 3, 4, and 5(5 years inclusive of parent study)
- Mean number of retina specialist visits attended for nAMD through years 2, 3, 4, and 5(5 years inclusive of parent study)
- Mean number of retina specialist visits attended for nAMD in years 2, 3, 4, and 5(5 years inclusive of parent study)