Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 6
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Anti-Vascular Endothelial Growth Factor (Drug)
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
干预措施: Anti-Vascular Endothelial Growth Factor (Drug)
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
干预措施: Anti-Vascular Endothelial Growth Factor (Drug)