A Phase 1 Study To Assess The Safety And Efficacy Of OCU200 For Center-Involved Diabetic Macular Edema
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Ocugen
- 入组人数
- 24
- 试验地点
- 10
- 主要终点
- Study Drug-related adverse events (SDAE)
研究概览
简要总结
A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema
详细描述
This is a multicenter, open-label, dose ranging study with 4 cohorts in the dose-escalation portion of the study. An accelerated 3+3 design with parallel and sequential dosing will be used.
Under the escalation design, 12 subjects will be enrolled if there are no DLTs and up to 24 subjects under the condition that exactly 1 of the 3 subjects of every cohort if determined to have a DLT.
Each subject will receive a total of 2 intravitreal injections of OCU200 6 weeks apart.
The DSMB will review the sentinel subject 1 week safety data post dosing in every cohort of all 3 subjects.
Cohort 1: 3+3 participants will receive intravitreal injection of OCU200.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Diagnosis of Type 1 or Type 2 Diabetes Mellitus
- •Decreased visual acuity attributable primarily to DME
- •Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:
- •≥ 320 but ≤ 450µm if male or ≥ 305 but ≤ 435µm if female on Heidelberg Spectralis
- •≥ 305 but ≤ 435µm if male or ≥ 290 but ≤ 420µm if female on Zeiss Cirrus
- •BCVA ≤ 78 and ≥ 24 letters on ETDRS chart
- •Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging
- •No history of prior anti-VEGF injection or history of at least 2 consecutive intravitreal anti-VEGF injection (less than 7 weeks apart) with incomplete resolution of CST within 1 year.
- •Note: The last anti-VEGF injection must be administered at least six weeks (45 days) prior to the study treatment (Day 1) in the study eye.
排除标准
- •Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)
- •Uncontrolled hypertension
- •Uncontrolled glaucoma
- •Concurrent disease in the study eye, other than central-involved DME
- •Intravitreal or periocular steroid treatment within 3 months prior to the screening visit
- •Any ocular surgery within 3 months prior to the screening visit in the study eye
- •Uncontrolled/poorly controlled diabetes (Glycated hemoglobin (HbA1c) ≥ 10%)
- •History of retinal detachment in the study eye or other retinal vascular disease in the study eye
- •Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit
- •Presence of any inherited retinal disease or history of proliferative diabetic retinopathy
- •History of Renal disease including stage 3b or worse
研究组 & 干预措施
Cohort 4
3+3 participants will receive intravitreal injection of OCU200 (5 mg/mL concentration).
干预措施: OCU200 (Drug)
Cohort 1
3+3 participants will receive intravitreal injection of OCU200 (0.5 mg/mL concentration).
干预措施: OCU200 (Drug)
Cohort 3
3+3 participants will receive intravitreal injection of OCU200 (2 mg/mL concentration).
干预措施: OCU200 (Drug)
Cohort 2
3+3 participants will receive intravitreal injection of OCU200 (1 mg/ML concentration).
干预措施: OCU200 (Drug)
结局指标
主要结局
Study Drug-related adverse events (SDAE)
时间窗: 24 weeks
Counts, frequencies and percentages of SDAEs.
Study Drug-related adverse events (SDAE)
时间窗: 24 weeks
Counts, frequencies and percentages of SDAEs.
Treatment-emergent adverse events (TEAEs)
时间窗: 24 weeks
Counts, frequencies and percentages TEAEs.
Serious adverse events (SAEs)
时间窗: 24 weeks
Counts, frequencies and percentages of SAEs.
次要结局
- Best-corrected visual acuity (BCVA)(24 Weeks (Changes from baseline))
- Intraocular pressure (IOP)(24 weeks(Changes from baseline))
- Color fundus photography(24 Weeks(Changes from baseline))
- Spectral Domain Optical Coherence Tomography (SD-OCT)(24 Weeks(Changes from baseline))
- Spectral Domain Optical Coherence Tomography Angiography (SD-OCTA)(24 weeks (Changes from baseline))
- Wide-field Fluorescein Angiography (wf-FA)(24 weeks (Changes from baseline))
- Best-corrected visual acuity (BCVA)(24 Weeks (Changes from baseline))
- Intraocular pressure (IOP)(24 weeks(Changes from baseline))
- Color fundus photography(24 Weeks(Changes from baseline))
- Spectral Domain Optical Coherence Tomography (SD-OCT)(24 Weeks(Changes from baseline))
- Spectral Domain Optical Coherence Tomography Angiography (SD-OCTA)(24 weeks (Changes from baseline))
- Wide-field Fluorescein Angiography (wf-FA)(24 weeks (Changes from baseline))