A Two-year Non-interventional, Real-world, Observational Study to Assess Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Patients With Diabetic Macular Edema in China
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 13
- 主要终点
- Number of Participants with Treatment Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs)
研究概览
简要总结
The dexamethasone intravitreal implant (OZURDEX) delivers dexamethasone gradually to the retina over time. It is an approved drug for the treatment of diabetic macular edema (DME). This study will assess the long-term safety and effectiveness of OZURDEX in adult participants with DME in the routine clinical setting in China.
Approximately 110 participants who are prescribed OZURDEX by their physicians will be enrolled in multiple medical institutions in China where OZURDEX is used for DME in routine clinical practice.
Participants will be followed for 24 months after the first administration of OZURDEX according to the routine clinical practice of the prescribing centers. A subsequent 30-day follow-up after the last dose will be performed to obtain information on any new or ongoing safety events and concomitant medications.
No additional burden for participants in this trial is expected.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •- Participant scheduled to receive at least one intravitreal OZURDEX® injection for DME as per most current local approved label after its approval for DME in China.
排除标准
- •Concurrent participation in interventional clinical research that required treatment or use of an investigational agent.
- •Participants for whom OZURDEX® is contraindicated:
- •Participants with known hypersensitivity to OZURDEX® or any components of this product.
- •Participants with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
- •Participants with late stage glaucoma that cannot be controlled with medication alone.
- •Aphakia with ruptured posterior lens capsule.
- •Eyes with anterior chamber intraocular lenses (ACIOL), iris- or scleral-fixated intraocular lenses, and ruptured posterior lens capsule.
结局指标
主要结局
Number of Participants with Treatment Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESIs)
时间窗: Up to approximately 24 months
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The AESIs can include the following: cataracts, elevated IOP and conjunctival hemorrhage.
次要结局
未报告次要终点