INV-102 眼药水治疗成人非中心受累糖尿病性黄斑水肿与非增殖性糖尿病视网膜病变相关的研究
INV-102 眼药水治疗与非增殖性糖尿病视网膜病变 (NPDR) 相关的非中心糖尿病性黄斑水肿 (NCIDME) 受试者的 2a 期试验、开放标签、多中心研究
Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with non-center involved DME (NCIDME) associated with NPDR [Part 1] and during an 8-week dosing period in subjects with center-involved DME (CIDME) associated with NPDR [Part 2].
研究概览
地位
干预/治疗
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Texas
-
Dallas、Texas、美国、75204
- MedTrials, Inc.
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Key Inclusion Criteria:
- Male or female subjects ≥ 18 years of age and < 76 years of age
- Diagnosed with diabetes (Type 1 or 2) with hemoglobin A1c ≤ 12.0%
- Study eye must have NCIDME (Part 1) or CIDME (Part 2)
- Study eye must be moderate to severe NPDR
Key Exclusion Criteria:
- Prior laser treatment for DR in the study eye within 12 months from Screening Visit
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 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 |
|---|---|
|
实验性的：Part 1: INV-102 0.7% in NCIDME
INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 10 weeks |
0.7% Ophthalmic Solution |
|
实验性的：Part 2: INV-102 0.7% in CIDME
INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 6 weeks |
0.7% Ophthalmic Solution |
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 from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score
大体时间：Day 84 (Part 1) and Day 56 (Part 2)
|
Graded by an independent central reading center using Wide-field Color Fundus Photography. The DRSS divides diabetic retinopathy into levels ranging from absence of retinopathy (score = 10) to advanced retinopathy (score = 85). The scale is used to describe overall retinopathy severity as well as the change in severity over time. |
Day 84 (Part 1) and Day 56 (Part 2)
|
|
Change from baseline in central subfield thickness (Part 2 only)
大体时间：Day 56
|
Measured using spectral domain optical coherence tomography (SD-OCT) and determined by an independent central reading center. |
Day 56
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
更改最佳校正视力（BCVA）（仅第2部分）
大体时间：第56天
|
第56天
|
|
|
Change from baseline in macular volume
大体时间：Day 84 (Part 1) and Day 56 (Part 2)
|
Measured using spectral domain optical coherence tomography (SD-OCT) |
Day 84 (Part 1) and Day 56 (Part 2)
|
|
Change from baseline in subfield thickness
大体时间：Day 84 (Part 1) and Day 56 (Part 2)
|
Mean retinal thickness in each of the regional subfields of the ETDRS grid, measured using SD-OCT |
Day 84 (Part 1) and Day 56 (Part 2)
|
|
Change from baseline in the retinal thickness at the thickest point of the subfield thickness
大体时间：Day 84 (Part 1) and Day 56 (Part 2)
|
Measured using SD-OCT in each of the regional subfields of the ETDRS grid |
Day 84 (Part 1) and Day 56 (Part 2)
|
合作者和调查者
调查人员
- 学习椅：Robert Shalwitz、Invirsa, Inc.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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