A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy With and Without Center Involved-Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 34
- 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 DR with and without center involved-diabetic macular edema (CI-DME) 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 a total of 5 years post-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 for the treatment of DR with or without CI-DME 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
Standard of Care
Dose Level (DL) 1-3 participants who received ABBV-RGX-314 in a parent study will continue to receive standard of care for the study duration.
干预措施: Standard of Care (Drug)
Supplemental Treatment
DL4 participants from parent study will be eligible to receive supplement aflibercept through a prespecified timepoint based on protocol-specified criteria if they develop worsening CI-DME or high-risk proliferative diabetic retinopathy (PDR) in the study eye.
干预措施: Standard of Care (Drug)
Supplemental Treatment
DL4 participants from parent study will be eligible to receive supplement aflibercept through a prespecified timepoint based on protocol-specified criteria if they develop worsening CI-DME or high-risk proliferative diabetic retinopathy (PDR) in the study eye.
干预措施: Aflibercept (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 the parent study
Incidence of overall and ocular adverse events, serious adverse events, and all adverse events of special interest
Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs)
时间窗: 5 years inclusive of the parent study
To evaluate the long-term safety of ABBV-RGX-314
次要结局
- Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA(5 years, inclusive to the parent study)
- Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in central subfield thickness as measured by SD-OCT(5 years, inclusive to the parent study)
- Proportion of participants requiring any additional intervention for ocular diabetic complications (eg, anti-VEGF intravitreal injection or PRP)(5 years, inclusive to the parent study)
- Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in DR by ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography(5 years, inclusive of the parent study)
- Proportion of participants achieving 0-step (no change), a 1-step or greater, a 2-step or greater, or a 3-step or greater improvement in DR per ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography from baseline(5 years, inclusive to the parent study)
- Proportion of participants with any sight-threatening ocular diabetic complications(5 years, inclusive to the parent study)
- Proportion of participants gaining or losing ≥5, 10 and 15 letters in BCVA compared with baseline (ie, prior to RGX-314 administration in the parent study)(5 years, inclusive to the parent study)
- Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in the area of retinal nonperfusion on ultra-widefield Optos FA(5 years, inclusive to the parent study)
- Proportion of participants achieving 0-step (no change), a ≥1-step, a ≥2-step, or a ≥3-step or greater change in DR per ETDRS-DRSS on digital stereoscopic fundus photography from baseline (ie, prior to ABBV-RGX-314 administration in the parent study)(5 years, inclusive to the parent study)
- Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA(5 years, inclusive to the parent study)
- Incidences of non-ocular AEs and any Adverse Events of Special Interest(5 years, inclusive to the parent study)
- Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in DR by ETDRS-DRSS on digital stereoscopic fundus photography(5 years, inclusive of the parent study)
- Proportion of participants gaining or losing ≥ 5, 10, and 15 letters in BCVA compared with baseline (ie, prior to ABBV-RGX-314 administration in the parent study)(5 years, inclusive to the parent study)
- Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CST as measured by SD-OCT(5 years, inclusive to the parent study)
- Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in the area of retinal nonperfusion on ultra-widefield Optos FA(5 years, inclusive to the parent study)
- Mean number of anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)(5 years, inclusive to the parent study)
- Mean number of anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)(5 years, inclusive to the parent study)
- Mean anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)(5 years, inclusive to the parent study)
- Mean anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)(5 years, inclusive to the parent study)
- Mean number of retina specialist visits attended for complications of DR based on chart review(5 years, inclusive to the parent study)