An Evaluation of the Long Term Safety and Efficacy of AAVAnc80-antiVEGF Gene Therapy in Individuals With Vestibular Schwannoma
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Akouos, Inc.
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Long term safety of AAVAnc80-antiVEGF, including late-occurring adverse events (AEs
研究概览
简要总结
This multi-center, observational, post-intervention LTFU study will monitor for safety and efficacy of AAVAnc80- antiVEGF in individuals with vestibular schwannoma who have previously received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial
详细描述
After completing one year of initial safety and efficacy assessments following an intracochlear administration of AAVAnc80-antiVEGF, participants will continue to be observed for an additional approximately four years of safety and efficacy follow-up in this LTFU study, for a total of approximately five years observations after product administration. For each participant, evaluations in the LTFU study will occur at annual visits through Year 5; with the aim to characterize long-term safety, including potential delayed adverse events, as well as characterizing the durability of effect of AAVAnc80-antiVEGF
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual with vestibular schwannoma who received an intracochlear administration of
- •AAVAnc80-antiVEGF in an interventional clinical trial.
- •Participant willingness to comply with all study requirements as evidenced by successful completion of the informed consent process.
排除标准
- •Any condition that would not allow the potential participant to complete follow-up examinations during the course of the study and/or, in the opinion of the Investigator, makes the potential participant unsuitable for the study.
研究组 & 干预措施
Study Participants
Individuals with vestibular schwannoma who received an intracochlear administration of AAVAnc80-antiVEGF in an interventional clinical trial.
结局指标
主要结局
Long term safety of AAVAnc80-antiVEGF, including late-occurring adverse events (AEs
时间窗: Through study completion, approximately four years.
1. the development of new or exacerbation of malignancies (oncologic), neurologic, rheumatologic or other autoimmune, hematologic disorders, or new infections (if the infection is potentially related to AAVAnc80-antiVEGF) 2. AEs that are related to the IMP and/or the administration procedure 3. AEs of special interest 4. all serious adverse events, regardless of severity
次要结局
- Tumor Volume(Through study completion, approximately four years.)
- Pure-tone audiometry(Through study completion, approximately four years.)
- Word recognition testing(Through study completion, approximately four years.)
- Otologic questionnaires(Through study completion, approximately four years.)