A Randomized, Controlled, Subject- and Evaluator-Masked, Phase 2 Clinical Trial Comparing EC-104 Intravitreal Implant to Ozurdex® for the Treatment of Diabetic Macular Edema (BETTIS-1)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Ocular and Systemic Safety
研究概览
简要总结
This is a prospective, randomized, subject- and evaluator-masked, Phase 2, multicenter study comparing the safety and efficacy of EC-104-6M high-dose (fluocinolone acetonide [FA] 0.14 mg) implant and EC-104-4M low-dose (FA 0.092 mg) implant to Ozurdex® (dexamethasone intravitreal (IVT) implant, 0.7 mg) in subjects with diabetic retinopathy (DR) and center-involving diabetic macular edema (DME), with prior suboptimal clinical response to IVT anti-VEGF therapy who have been previously treated with locally administered corticosteroids without a clinically significant rise in intraocular pressure (IOP).
详细描述
Approximately 75 subjects who meet entry criteria will be randomized 1:1:1 to EC-104-6M high-dose (FA 0.14 mg) implant or EC-104-4M low-dose (FA 0.092 mg) implant or Ozurdex® (dexamethasone IVT implant 0.7 mg), with the goal of achieving approximately 20 subjects per group with a positive therapeutic response in their study eyes, who are evaluable in the primary endpoint analysis to assess efficacy. Subjects with a positive therapeutic response at Week 4 will be included in the primary and secondary endpoint analyses to assess efficacy for "Time to recurrent disease." Subjects who do not achieve a positive therapeutic response will be classified as suboptimal responders. While suboptimal responders will not be included in the primary and the secondary endpoint analyses to assess efficacy for "Time to recurrent disease," they will remain in the study and will be followed prospectively, with inclusion in the remaining endpoints to assess efficacy and all safety endpoint analyses
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
- Double (Participant, Outcomes Assessor)
盲法说明
Evaluators of efficacy study assessments will be masked. The injecting physician and the injection technician or clinical assistant preparing the IP for administration will be unmasked to the identity of the specific investigational product (IP)
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
- •Males or females who are at least 18 years of age at the time of informed consent
- •Willing and able to provide signed informed consent (participant or legally authorized representative) prior to any study-related procedures and to comply with all study visits and cooperate with all examinations
- •Diagnosis of diabetes mellitus (Type 1 or Type 2), with history of diabetic macular edema (DME) < = years duration prior to Screening Visit 1
- •Currently monitored hemoglobin A1c values ≤ 10.0 while under the care of a qualified medical provider for diabetes mellitus management, unless provider allows value variance
- •Inclusion criteria for the study eye (all of the below criteria must be met in the same eye):
- •Early Treatment Diabetic Retinopathy Study BCVA score ≤ 70 letters (Snellen equivalent 20/40 or worse) and ≥ 20 letters (Snellen equivalent 20/400) in at least 1 eye
排除标准
- •Previous or current diagnosis of any form of glaucoma (defined as cup-to-disc ratio > 0.7) or ocular hypertension (documented intraocular pressure (IOP) > 21 mm Hg without glaucomatous disc damage) requiring medical or surgical intervention
- •History of steroid-induced IOP elevation > 25 mm Hg
- •Presence of active proliferative diabetic retinopathy, defined as active neovascularization of disc (NVD), neovascularization elsewhere (NVE), neovascularization of iris (NVI), neovascularization of angle (NVA), or vitreous hemorrhage in the setting of active NVD or NVE
研究组 & 干预措施
Dexamethasone intravitreal implant
Marketed product
干预措施: Dexamethasone intravitreal implant (Drug)
EC-104 high dose
Intravitreal implant of fluocinolone acetonide
干预措施: EC-104 high dose (Drug)
EC-104 low dose
Intravitreal implant of fluocinolone acetonide
干预措施: EC-104 low dose (Drug)
结局指标
主要结局
Ocular and Systemic Safety
时间窗: Through Week 24
Incidence of Adverse events
次要结局
- Diabetic macular edema recurrence(Through Week 24)