Phase 2a Pilot, Open Label, Multicenter, Study of INV-102 Ophthalmic Solution in Subjects With Diabetic Macular Edema (DME) Associated With Non-proliferative Diabetic Retinopathy (NPDR)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score
研究概览
简要总结
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].
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prior laser treatment for DR in the study eye within 12 months from Screening Visit
研究组 & 干预措施
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
干预措施: INV-102 (Drug)
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
干预措施: INV-102 (Drug)
结局指标
主要结局
Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score
时间窗: 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.
Change from baseline in central subfield thickness (Part 2 only)
时间窗: Day 56
Measured using spectral domain optical coherence tomography (SD-OCT) and determined by an independent central reading center.
次要结局
- Change in best corrected visual acuity (BCVA) (Part 2 only)(Day 56)
- Change from baseline in macular volume(Day 84 (Part 1) and Day 56 (Part 2))
- Change from baseline in subfield thickness(Day 84 (Part 1) and Day 56 (Part 2))
- Change from baseline in the retinal thickness at the thickest point of the subfield thickness(Day 84 (Part 1) and Day 56 (Part 2))