A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 23
- 试验地点
- 9
- 主要终点
- Severity and incidence of ocular and systemic adverse events (AEs).
研究概览
简要总结
ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in participants with neovascular, or exudative (wet), age-related macular degeneration (nAMD).
详细描述
ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and maintaining the vision of patients. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet AMD receiving anti-VEGF therapy in clinical practice.
ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product in participants with neovascular or exudative (wet), age-related macular degeneration (nAMD) previously treated in the OPTIC parent study (Clinical Protocol No. ADVM-022-01 [OPTIC] - NCT03748784). There is no investigational treatment administered in this study.
In Part 1 of the OPTIC-EXT study participants will roll over from the OPTIC parent study and will be followed for 3 additional years (following 2-years of assessment period in the OPTIC parent study). In Part 2 of the OPTIC-EXT study consenting participants will have 5 annual in-clinic assessments for an additional 5 years of long-term follow-up following the completion of OPTIC-EXT (Part 1). As such participants who complete the parent study as well as Part 1 and Part 2 of the OPTIC-EXT study will have had 10 years of total long-term follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who received a single dose of ADVM-022 at any dose in the OPTIC study
- •Willing and able to provide informed consent
排除标准
- 未提供
研究组 & 干预措施
1
Participants with wet AMD who received any dose of ADVM-022 in a prior clinical study.
干预措施: ADVM-022 (Biological)
结局指标
主要结局
Severity and incidence of ocular and systemic adverse events (AEs).
时间窗: 416 weeks (8 years)
Severity and incidence of ocular and systemic adverse events
次要结局
- Mean change in best corrected visual acuity (BCVA) from baseline, over time(416 weeks (8 years))
- Mean change in central subfield thickness (CST) and macular volume from baseline, over time(416 weeks (8 years))
- Mean number of supplemental aflibercept injections over time(416 weeks (8 years))
- Percentage of participants requiring supplemental bolus aflibercept over time(416 weeks (8 years))
- Time to first supplemental aflibercept requirement(416 weeks (8 years))
- Percentage of participants without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time(416 weeks (8 years))
- Percentage of participants without subretinal fluid (SRF) by SD-OCT over time(416 weeks (8 years))
- Time to first dry retina (defined as no IRF or SRF by SD-OCT)(416 weeks (8 years))
- Duration of fluid free status (defined as no IRF or SRF by SD-OCT)(416 weeks (8 years))
- Percentage of participants developing geographic atrophy over time (as assessed by multiple imaging modalities)(416 weeks (8 years))
- Growth of geographic atrophy over time, as assessed by multiple imaging modalities(416 weeks (8 years))
- Percentage of participants with CST fluctuations > 50 μm over time(416 weeks (8 years))