Assessment of the Safety and Drug Utilization of Intravitreal Aflibercept Injection in Mexican Routine Clinical Practice for the Treatment of Wet Age Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME), Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO), Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO) and Myopic Neovascularization (mCNV). A Post-authorization Safety Study (PASS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Number of ocular adverse events
研究概览
简要总结
The study aims to collect data on the safety and use of intravitreal aflibercept injections into the eye for the treatment of eye disorders that cause blurred vision or a blind spot due to abnormal or blocked blood vessels. Data will be collected from patients who are being treated for such eye disorders in Mexican routine clinical practice.
详细描述
The primary objective is to assess the safety of intravitreal aflibercept injections in patients with wet age-related macular degeneration (wAMD), myopic choroidal neovascularization (mCNV), diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO) or macular edema secondary to branch retinal vein occlusion (BRVO).
Secondary objectives comprise the comparison of the aflibercept safety profile between defined subgroups and the assessment of the real-world application of intravitreal aflibercept injections with special focus on CRVO, BRVO and mCNV indications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adult patients with a diagnosis of a wet age-related macular degeneration (wAMD), diffuse diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO), macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV);
- •Decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice and independently of study inclusion;
- •Treatment naïve or pre-treated for macular diseases (to anti-VEGF and steroid intravitreal treatments); patients who underwent laser photocoagulation and/or are being treated with panretinal photocoagulation therapies are eligible for study participation;
- •If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept
排除标准
- •Patient diagnosed with two or more of the studied indications in the same eye (wAMD, DME, CRVO, BRVO and mCNV);
- •Patients that were already treated with anti-VEGF or steroids are allowed to be enrolled only if they received the last dose of anti-VEGF 3 or more months ago and in the case of a steroid implant 6 months after the last dose;
- •Current treatment with other intravitreal therapies
- •Contra-indications according to Eylea's / Wetlia's local marketing authorization:
- •Ocular or periocular infection
- •Active intraocular Inflammation
- •Known hypersensitivity to aflibercept or to any of its excipients
- •Pregnant or lactating women.
- •Participation in an interventional study
研究组 & 干预措施
Patients_Ocular disease
Adult patients treated for wet age-related macular degeneration (wAMD), or diabetic macular edema (DME), or macular edema secondary to central retinal vein occlusion (CRVO), or macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV) in routine clinical practice in Mexico (overall cohort)
干预措施: Aflibercept (BAY86-5321, Eylea) (Drug)
结局指标
主要结局
Number of ocular adverse events
时间窗: Up to 12 months
Number of serious ocular adverse events
时间窗: Up to 12 months
Seriousness reason for ocular adverse events
时间窗: Up to 12 months
Seriousness reasons may be death, life-threatening character of event, hospitalization or prolongation of hospitalization, congenital anomaly/ birth defect, persistent or significant impairment, or medical relevance of adverse event.
Severity of ocular adverse events
时间窗: Up to 12 months
The severity of adverse events is classified as mild, moderate or severe by treating physician.
Number of treatment-related ocular adverse events
时间窗: Up to 12 months
Number of treatment-related non-ocular adverse events
时间窗: Up to 12 months
Number of injection-related ocular adverse events
时间窗: Up to 12 months
Action taken with drug after ocular adverse event
时间窗: Up to 12 months
Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed
Clinical outcome of ocular adverse event
时间窗: Up to 12 months
Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown
Duration of ocular adverse events
时间窗: Up to 12 months
Duration of patient follow-up after ocular adverse event (in months)
时间窗: Up to 12 months
Number of non-ocular adverse events
时间窗: Up to 12 months
Number of serious non-ocular adverse events
时间窗: Up to 12 months
Seriousness reason for non-ocular adverse events
时间窗: Up to 12 months
Seriousness reasons may be death, life-threatening character of event, hospitalization or prolongation of hospitalization, congenital anomaly/ birth defect, persistent or significant impairment, or medical relevance of adverse event.
Severity of non-ocular adverse events
时间窗: Up to 12 months
The severity of adverse events is classified as mild, moderate or severe by treating physician.
Number of injection-related non-ocular adverse events
时间窗: Up to 12 months
Action taken with drug after non-ocular adverse event
时间窗: Up to 12 months
Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed
Clinical outcome of non-ocular adverse event
时间窗: Up to 12 months
Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown
Duration of non-ocular adverse events
时间窗: Up to 12 months
Duration of patient follow-up after non-ocular adverse event (in months)
时间窗: Up to 12 months
次要结局
- Total number of injections with intravitreal aflibercept per study eye(Up to 12 months)
- Time between injections in the study eye (in days)(Up to 12 months)
- Time between injections in the study eye and fellow eye (in days)(Up to 12 months)
- Number of patients receiving bilateral treatment(Up to 18 months)