NCT05066698终止2 期
A Phase 2b, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of ST266 Eye Drops in the Treatment of Persistent Corneal Epithelial Defects
Noveome Biotherapeutics, formerly Stemnion61 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年4月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 61
- 主要终点
- Clinical Success
研究概览
简要总结
The primary objective is to determine the efficacy of ST266 eye drops in healing persistent epithelial defects (PED). After 8 weeks of randomized, double-blind treatment, non-healers will enter into an additional 8-week open-label ST266 treatment period. All patients will be followed for 3-months post-treatment for monitoring of safety and maintenance of re-epithelialization.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and non-pregnant/non-breastfeeding female subjects aged 18 years and older.
- •Subjects with a PED present for at least seven (7) days at the time of Screening.
- •The defect must be at least 1.0 mm (longest linear measurement) at Screening and Baseline (Day 1) and must be measurable by slit lamp.
- •In the Investigator's opinion, the defect is persistent i.e., the defect has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
- •The original defect to the cornea must be the result of an injury, infection, disease, or surgery to the eye.
排除标准
- •Diabetic cohort only: enrollment will be limited to include up to 50% of subjects with diabetes, as indicated by HbA1c level >6.5%. Subjects with a HbA1c level >6.5% after closure of the diabetic cohort will be excluded.
- •Subjects currently being treated with cenegermin or other rhNGF in the study eye.
- •Subjects currently using topical antibiotic eye drops in the study eye. Subjects on current antibiotic therapy must be willing to switch to study-provided moxifloxacin.
- •Subjects currently taking topical steroids or corticosteroid-containing eye drops or ointment in the study eye. Subjects currently taking systemic corticosteroids with a dose of >10mg/day prednisone or equivalent.
- •Subjects currently using topical antihistamine eye drops or vasoconstrictors in the study eye.
- •Subjects currently using topical or local immunosuppressive agents (e.g., optic cyclosporine or lifitegrast) in the study eye.
- •Subjects who require treatment with autologous serum eyedrops or amnion products in the study eye.
- •Subjects who need to use contact lenses for refractive correction during the study.
- •Subjects who require treatment with bandage contact lens or punctal plugs in the study eye that cannot be removed.
- •Subjects currently taking antiviral medications for an active infection in the study eye. Subjects taking antiviral medications for prophylaxis may be enrolled in the study at the Investigator's discretion, provided that the subject remain on a stable dosing regimen throughout the duration of the study.
- •History of ocular surgery (including laser or refractive surgery) in the study eye within 1 month prior to study screening or, in the opinion of the Investigator, there are persistent post-surgical complications that would impact the study data.
- •Subjects with an uncontrolled lid or ocular infection in the study eye.
- •History of alkali burns of the cornea.
- •The circumference affected by limbal blood vessel ischemia is greater than 75 percent of the limbal circulation.
- •Subjects with severe lid abnormalities contributory to the persistence of the PED such as inability to close the lids.
- •Subjects who have a history of AIDS or HIV.
- •Subjects who have participated in a clinical trial (including a previous study involving ST266) within 30 days prior to Day
- •Subjects who have more than one distinct PED in the study eye prior to screening visits. Subjects who develop PEDs after the screening visit will remain in the study; however, only the original study PED will be assessed.
- •For subjects with bilateral PEDs, only the eye with the larger PED should be entered into the study. The non-study eye will receive standard of care treatment and be observed throughout the trial.
- •Subjects with bullous keratopathy in the study eye.
- •Subjects with corneal perforation or impending corneal perforation in the study eye.
- •Subjects with uncontrolled glaucoma.
- •Female subjects who are pregnant or breastfeeding. Female subjects who are neither postmenopausal for at least 1 year nor surgically sterile require a negative urine pregnancy test. All subjects must use an acceptable form of birth control during the study such as abstinence, barrier method, or hormonal contraceptive.
- •Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren's ulceration.
- •Subjects with recurrent corneal erosion or corneal basement membrane dystrophy.
- •Known hypersensitivity to study provided lubricating drops, antibiotic drops, and/or procedural medications such as fluorescein dye.
- •Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ST266.
结局指标
主要结局
Clinical Success
时间窗: 8 weeks
Proportion of subjects with clinical success between ST266 and placebo arms, defined as complete re-epithelialization of the corneal epithelial defect by week 8 of treatment.
次要结局
- Safety of ST266(7 months)
- Maintenance of re-epithelialization during treatment(8 weeks)
- Clinical Success in Open-Label Extension(8 weeks)
- Maintenance of re-epithelialization post-treatment(12 weeks)
- Change in BCVA from Baseline(7 months)
- Time to re-epithelialization(8 weeks)
- Incidence of Rescue Therapy(8 weeks)
- Size of Defect(7 months)
- Use of Lubricating Drops(8 weeks)
- VAS Score(8 weeks)
研究者
研究点 (61)
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