Evaluation of an Updated Dexamethasone Posterior Segment Drug Delivery System Applicator in Participants With Macular Edema Due to Retinal Diseases
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 7
- 主要终点
- Number of Participants Experiencing at Least One Adverse Events (AEs)
研究概览
简要总结
The Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator is used to deliver an implant with medicine to the eye. AbbVie is updating the DEX PS DDS Applicator. This purpose of this study is to show that the updated DEX PS DDS Applicator works in adult participants with macular edema due to retinal diseases.
The DEX PS DDS is approved for the treatment of macular edema. Participants will be placed into 1 of 2 groups, called treatment arms. Each group receives the same treatment drug delivered using different applicators. Around 54 adult participants with macular edema will be enrolled in the study in approximately 7-10 sites in the United States.
Participants will receive a single intravitreal (into the eye) administration of DEX PS DDS implant using either the currently-approved DEX PS DDS Applicator or the the updated Applicator. The participants will be observed for a duration of 7 days, with the DEX PS DDS implant received on day 1 and follow-up through day 7.
The updates being evaluated in this study are related to the DEX PS DDS Applicator only, with the safety and efficacy of the DEX PS DDS implant well characterized and the same as the currently marketed product. Participants will attend regular visits during the study at a hospital or clinic. The applicator function will be checked by medical assessment, checking for side effects, procedural complications and/or product complaints, and evaluating the administration procedure.
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
- 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
- 否
入选标准
- •Participants with macular edema due to retinal vein occlusion (branch retinal vein occlusion or central retinal vein occlusion) or diabetic macular edema.
排除标准
- •Participants with ocular conditions in the study eye for which Dexamethasone Posterior Segment Drug Delivery System Implant is contraindicated.
研究组 & 干预措施
Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg
DEX PS DDS 0.7 mg implant was administered intravitreally into the study eye using updated applicator at Day 1 and followed until Day 7.
干预措施: Updated DEX PS DDS Applicator (Device)
Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg
DEX PS DDS 0.7 mg implant was administered intravitreally into the study eye using updated applicator at Day 1 and followed until Day 7.
干预措施: Dexamethasone (Drug)
Approved DEX PS DDS 0.7 mg
DEX PS DDS 0.7 mg implant was administered into the study eye using currently approved applicator at Day 1 and followed until Day 7.
干预措施: Approved DEX PS DDS Applicator (Device)
Approved DEX PS DDS 0.7 mg
DEX PS DDS 0.7 mg implant was administered into the study eye using currently approved applicator at Day 1 and followed until Day 7.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Number of Participants Experiencing at Least One Adverse Events (AEs)
时间窗: Up to 7 Days After Study Drug Administration
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
次要结局
未报告次要终点