A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 2 Study of EO2002 in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction (EMERALD)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- BCVA
研究概览
简要总结
This study will evaluate the safety and effectiveness of a single injection of EO2002 at one of two dose levels (150,000 or 500,000 magnetic human corneal endothelial cells [mHCECs]), compared with a placebo injection, in participants with corneal edema caused by corneal endothelial dysfunction.
详细描述
This study is designed to evaluate the safety and efficacy of EO2002, an investigational magnetic human corneal endothelial cell (mHCEC) therapy, in adults with corneal edema secondary to corneal endothelial dysfunction. Participants will be randomized to receive a single intracameral injection of one of two doses of EO2002 (150,000 or 500,000 cells) or placebo.
The study will compare the effects of EO2002 on visual acuity and corneal thickness, while also evaluating safety over a 52-week follow-up period. Approximately 105 participants will be treated at multiple sites in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic central corneal edema that is primarily responsible for loss of vision associated with endothelial dysfunction which may be secondary to Fuchs corneal dystrophy or pseudophakic bullous keratopathy.
- •Early Treatment Diabetic Retinopathy Study (ETDRS)-best-corrected distance visual acuity between 20 and 65 letters inclusive (≥ 20 and ≤ 65 letters)
- •Central corneal thickness ≥ 600 μm and ≤ 1,000 μm, OR Medical Monitor review and approval based on either:
- •Historical CCT increased by ≥ 50 μm OR
- •Findings of edema by corneal tomography or Anterior Segment Optical Coherence Tomography (AS-OCT).
- •Participant is considered a surgical candidate for full-thickness corneal transplantation or endothelial (partial thickness) keratoplasty (EK) consistent with standard-of-care indications.
排除标准
- •Corneal disease in either eye (other than corneal endothelial dysfunction secondary to Fuchs dystrophy or pseudophakic bullous keratopathy) including active or prior herpetic ocular infection, severe dry eye disease (e.g., Sjogren's), or active inflammation.
- •Central corneal scarring from trauma, burns, or infection, or band keratopathy
- •History of keratoconus or other corneal ectasia (e.g., keratoglobus and pellucid marginal degeneration).
- •Visually significant cataract, that may limit the participant's ability to demonstrate treatment-related improvement in BCVA.
- •Presence of an anterior chamber, sutured, or scleral-fixated intraocular lens.
- •Presence of a multifocal or diffractive intraocular lens.
- •Prior vitrectomy.
- •Corneal refractive surgery.
- •Descemet dettachment
- •Minimally invasive glaucoma surgery (MIGS), intraocular pressure (IOP)- lowering implant (e.g., Durysta® or iDose®), or any incisional glaucoma surgery (e.g., trabeculectomy, glaucoma drainage implant).
研究组 & 干预措施
150K cells - EO2002
Intracameral injection of 150K magnetic human corneal endothelial cells
干预措施: 150K cells (Biological)
500K cells - EO2002
Intracameral injection of 500K magnetic human corneal endothelial cells
干预措施: 500K cells (Biological)
Placebo
Intracameral injection of vehicle (no cells)
干预措施: Placebo (Procedure)
结局指标
主要结局
BCVA
时间窗: 26 weeks
Proportion of study eyes achieving ≥ 15-letter best-corrected visual acuity (BCVA) improvement at 26 weeks post-treatment as compared to baseline.
次要结局
- BCVA(26 weeks)
- CCT(26 weeks)