此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Study to Evaluate the Safety and Effect of TO-O-1007 Intravitreal Implant in Subjects With Geographic Atrophy

2026年6月21日 更新者：Theratocular Biotek Co.

A Phase I/IIa Trial to Evaluate the Safety, Tolerability and Efficacy After Single Administration of TO-O-1007 (Intravitreal Implant) in Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

This study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of TO-O-1007, a biodegradable sustained-release intravitreal implant, for the treatment of Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). A long-acting intravitreal implant providing sustained delivery of API over 6 months may slow the progression of GA lesions while reducing treatment burden associated with frequent intravitreal injections. TO-O-1007 may offer a convenient treatment option with the potential to preserve retinal structure and visual function while maintaining an acceptable safety profile.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

TO-O-1007 is a biodegradable sustained-release intravitreal implant, that is injected into the vitreous cavity of the eye. The implant is designed to gradually degrade over time, providing sustained ocular delivery of API for up to 6 months following a single administration. By continuously inhibiting C3/C5 activation, TO-O-1007 is intended to slow the progression of Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD), with the goal of preserving retinal structure and visual function. In this study, TO-O-1007 will be evaluated for its safety, tolerability, pharmacokinetics, and preliminary efficacy to determine whether it may offer a durable treatment option that reduces treatment burden compared with currently available therapies requiring more frequent intravitreal injections.

研究类型

介入性

注册 (估计的)

31

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 澳大利亚
    • New South Wales (nsw)
      • Hurstville、New South Wales (nsw)、澳大利亚、2220
        • 招聘中
        • Retina & Eye Consultants
        • 首席研究员：
          • Dr. Derek Chan
        • 接触：
      • Sydney、New South Wales (nsw)、澳大利亚、2000
        • 招聘中
        • Sydney Retina Clinic & Day Surgery
        • 首席研究员：
          • Dr. Andrew Chang
        • 接触：
    • Tasmania (tas)
      • Launceston、Tasmania (tas)、澳大利亚、7250

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Adults ≥50 years, able to provide informed consent and comply with study procedures.
  2. Non-foveal GA secondary to dry AMD, confirmed by the central reading center.
  3. Total GA area 2.5-17.5 mm² by FAF (≥1.25 mm² for at least one lesion if multifocal).
  4. BCVA ≥24 ETDRS letters (~20/320 Snellen) in the study eye.
  5. IOP ≤21 mmHg in the study eye.

Exclusion Criteria:

  1. Recent participation in intravitreal, GA, or investigational treatment studies.
  2. Pregnant or nursing women.
  3. High myopia (>8 D or axial length >27 mm).
  4. Prior AMD treatment or active/secondary CNV in the study eye.
  5. Current/prior uveitis.
  6. Recent anti-complement therapy.
  7. Use of prohibited medications, investigational products, or immunosuppressive therapies.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：TO-O-1007 Low-Dose Cohort (phase I)
3 participants will receive TO-O-1007 (low-dose)
药品：TO-O-1007 (low-dose)
TO-O-1007 (low-dose): Participants will receive one TO-O-1007 implant administered by intravitreal injection into the study eye.
实验性的：TO-O-1007 High-Dose Cohort (phase I)
3 participants will receive TO-O-1007 (high-dose)
药品：TO-O-1007 (high-dose)
TO-O-1007 (high-dose): Participants will receive two TO-O-1007 implants administered by intravitreal injection into the study eye.
实验性的：TO-O-1007 Low-Dose Arm 1 (phase IIa)
10 participants will receive TO-O-1007 (low-dose)
药品：TO-O-1007 (low-dose)
TO-O-1007 (low-dose): Participants will receive one TO-O-1007 implant administered by intravitreal injection into the study eye.
实验性的：TO-O-1007 High-Dose Arm 2 (phase IIa)
10 participants will receive TO-O-1007 (high-dose)
药品：TO-O-1007 (high-dose)
TO-O-1007 (high-dose): Participants will receive two TO-O-1007 implants administered by intravitreal injection into the study eye.
假比较器：TO-O-1007 Sham Arm 3 (phase IIa)
5 participants will receive a sham injection.
程序：Sham injection
Sham injection: No injection is given. It is a sham injection to keep the participant masked.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
大体时间：Up to 6 months treatment duration
Number and percentage of participants experiencing at least one treatment-emergent adverse event, including serious adverse events and adverse events of special interest.
Up to 6 months treatment duration

次要结果测量

结果测量
措施说明
大体时间
Geographic Atrophy Lesion Growth
大体时间：Baseline, Week 12, and Week 24.
Change in the growth rate of square root-transformed total Geographic Atrophy lesion area in the study eye, assessed by fundus autofluorescence (FAF) imaging through Week 24.
Baseline, Week 12, and Week 24.
Visual Function Assessments
大体时间：Week 12 and Week 24.
Mean change from baseline in BCVA, LL-BCVA, and low-luminance deficit (LLD), assessed using ETDRS charts under photopic and low-luminance conditions through Week 24.
Week 12 and Week 24.
Exposure endpoint (only for phase I)
大体时间：Day 1 pre-dose, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28 post first dosing.
Plasma concentrations of TO-O-1007
Day 1 pre-dose, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 and Week 28 post first dosing.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Theratocular Biotek Co.

调查人员

  • 首席研究员：Dr. Andrew Chang、Sydney Retina Clinic & Day Surgery

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月2日

初级完成 (估计的)

2027年8月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年6月16日

首先提交符合 QC 标准的

2026年6月21日

首次发布 (实际的)

2026年6月25日

研究记录更新

最后更新发布 (实际的)

2026年6月25日

上次提交的符合 QC 标准的更新

2026年6月21日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TO-I-1007

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅