An Open Label, One Year, Non-Comparative Study To Evaluate The Safety And Tolerability Of Intravitreous Pegaptanib Sodium In Patients With Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 46
- 试验地点
- 12
- 主要终点
- Incidence of Ocular and Non-Ocular Adverse Events (AEs)
研究概览
简要总结
This study will asses sthe safety of pegaptanib sodium in patients with diabetic macular edema. The hypothesis is that pegaptanib is safe and efficacious in patients with diabetic macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Subjects with documented clinical diagnosis of diabetic macular edema (DME) with proliferative or non proliferative diabetic retinopathy.
- •Subjects, who according to the clinical assessment of the investigator, may benefit from anti-VEGF therapy including those subjects who were participating in the A5751013 study and who, in the investigator's opinion, may benefit from continued pegaptanib sodium therapy.
排除标准
- •Eyes with prior scatter (panretinal) photocoagulation within 4 months prior to baseline or anticipated scatter (panretinal) photocoagulation within the next 6 months.
- •Presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema resolves, or improves, such as non-perfusion for >1 disc area involving the foveal avascular zone (FAZ - involving 2 or more quadrants centered around the foveal avascular zone), epiretinal membrane associated with signs of contraction and/or significant opacification (i.e. striae within 1 disc diameter of the foveal center), or presence of chorioretinal atrophy involving the center of the macula.
- •Vitreomacular traction determined clinically and/or by optical coherence tomography (OCT), which, in the investigator's opinion, contributes to the macular edema (or causes associated foveal detachment), and would preclude improvement with pegaptanib sodium.
- •Any other cause of macular edema such as vitreous extension, or entrapment to anterior segment wound, or any retinal vein occlusion involving the macula.
研究组 & 干预措施
pegaptanib sodium arm
all patients will receive pegaptanib sodium
干预措施: pegaptanib sodium (Drug)
结局指标
主要结局
Incidence of Ocular and Non-Ocular Adverse Events (AEs)
时间窗: Baseline up to 30 days after last dose
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Total number of participants who had ocular and non-ocular AEs was reported.
Mean Total Number of Injections
时间窗: Baseline up to Week 48 (End of treatment)
Mean number of injections per participant was calculated as (number of injection administered per participant - 1)/duration of treatment. Mean number of injections administered for total participants was summarized.
次要结局
- Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at Week 48 (End of Treatment)(Baseline, Week 48 (End of treatment))
- Incidence of Ocular and Non-Ocular Serious Adverse Events (SAEs)(Baseline up to 30 days after last dose)