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Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents (AS)

2026年9月15日 更新者：Jaeb Center for Health Research
A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

阶段

  • 第四阶段

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。

学习地点

  • 美国
    • Georgia
      • Augusta、Georgia、美国、30909
    • Massachusetts
      • Boston、Massachusetts、美国、02118
        • 招聘中
        • Boston Medical Center Corporation
        • 接触：
    • Michigan
      • Detroit、Michigan、美国、48202
        • 招聘中
        • Henry Ford Health System
        • 接触：
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • 招聘中
        • Mayo Clinic
        • 接触：
    • Pennsylvania
      • Monroeville、Pennsylvania、美国、15146
      • Sewickley、Pennsylvania、美国、15143
        • 招聘中
        • Pittsburgh Clinical Trial Consortium
        • 接触：

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

Key inclusion criteria:

  • Age ≥18 years
  • Diagnosed with Type 1 or Type 2 diabetes
  • Best corrected visual acuity 20/320 or better (Snellen) (≥24 ETDRS letters)
  • At least 1 eye with CI-DME requiring treatment
  • Able and willing to provide informed consent.

Key exclusion criteria:

  • Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina.
  • Previous treatment of any kind for diabetic retinopathy or DME
  • Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)
  • History of rhegmatogenous retinal detachment or macular hole
  • History of vitrectomy
  • Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months

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：其他
  • 分配：非随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Mild center-involved diabetic macular edema
Eyes with optical coherence tomography central subfield thickness <75 µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men
药品：Anti-Vascular Endothelial Growth Factor
All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).
其他名称：
  • 抗VEGF
有源比较器：Moderate Center-involved diabetic macular edema
Eyes with OCT central subfield thickness 75 to <175 µm above DRCR standard thresholds of: Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men
药品：Anti-Vascular Endothelial Growth Factor
All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).
其他名称：
  • 抗VEGF
有源比较器：Severe Center-involved diabetic macular edema
Severe CI-DME: Eyes with OCT central subfield thickness >=175µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men
药品：Anti-Vascular Endothelial Growth Factor
All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).
其他名称：
  • 抗VEGF

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
Change in multifocal pupillographic objective perimetry (mfPOP) response delays
大体时间：Baseline to 1 year
mfPOP response delays measured using the Objective Field Analyzer (OFA)
Baseline to 1 year
Change in area under the log contrast sensitivity function (AULCSF)
大体时间：Baseline to 1 year
AULCSF as measured by the Adaptive Sensory Testing (AST) Manifold contrast sensitivity testing system
Baseline to 1 year
Change in electroretinography parameter
大体时间：Baseline to 1 year
Measured by the RETeval device
Baseline to 1 year
Change in reading performance
大体时间：Baseline to 1 year
Measured by the MNREAD test
Baseline to 1 year
Change in visual field function
大体时间：Baseline to 1 year
Measured by Humphrey Visual Field testing
Baseline to 1 year
Change in diabetic retinopathy severity
大体时间：Baseline to 1 year
Assessed by ultra-widefield (UWF) color fundus photography
Baseline to 1 year
Change in retinal vascular pathology
大体时间：Baseline to 1 year
Assessed by ultra-widefield fluorescein angiography (UWF-FA)
Baseline to 1 year
Change in retinal structure
大体时间：Baseline to 1 year
measured by optical coherence tomography (OCT)
Baseline to 1 year
Change in retinal microvascular parameter
大体时间：Baseline to 1 year
Measured by optical coherence tomography angiography (OCTA)
Baseline to 1 year

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

Jaeb Center for Health Research

合作者

National Eye Institute (NEI)

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7月31日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年2月9日

首先提交符合 QC 标准的

2026年4月28日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • Protocol AS (1)
  • UG1EY014231 (美国 NIH 拨款/合同)

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.

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