试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)
研究概览
简要总结
The objective of this observational study is to evaluate the effectiveness and safety of Macugen for treatment of wet age-related macular degeneration (AMD) in Indian patients.Prospective, Observational, Non-interventional Study. The period of observation for the study will be 1 year
详细描述
To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD). The decision to prescribe Macugen will necessarily precede and will be independent of the decision to enroll patient into the study.
If both eyes of a patient receive injection Macugen, only one eye will be included in the study. If both eyes receive first injection Macugen after initiation of the study, only the first treated eye will be included in the analysis. If one eye has already received Macugen when the study starts and the second eye receives injection after the study initiation, the second eye will be included in the analysis.
The study was prematurely discontinued due to delay in meeting pre-defined protocol recruitment milestones on August 30, 2010. There were no safety concerns regarding the study in the decision to terminate the trial.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet age-related macular degeneration (AMD).
排除标准
- •Active or suspected ocular or periocular infection.
- •Known hypersensitivity to pegaptanib sodium or any other excipient in this product.
结局指标
主要结局
Percentage of Participants Showing Stabilization, Improvement or Deterioration of Visual Acuity (VA)
时间窗: Baseline through 12 months or last follow-up visit before study termination
VA was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if the participant was able only to count fingers, to perceive hand motion or light. VA was assessed as the number of ETDRS letters correctly read. VA statuses were defined as: Stabilization: loss of less than 15 letters in the best corrected VA (BCVA); Improvement: gain of more than or equal to 15 letters in the BCVA; Deterioration: loss of more than or equal to 15 letters in the BCVA.
Average Number of Injections to Achieve Stabilization of VA
时间窗: 12 months or last follow-up visit before study termination
Stabilization of VA was defined as loss of less than 15 letters in the BCVA. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.
Median Number of Injections to Achieve Stabilization of VA
时间窗: 12 months or last follow-up visit before study termination
Stabilization of VA was defined as loss of less than 15 letters in the BCVA. Median number of injections to achieve stabilization of VA was estimated via the Kaplan Meier method. For each participant, number of injections before reaching the first "stabilization in VA" (considered as an event) was counted. For participant having no event, the time to the number of injections to reach an event was unobserved at the number of injections before the last follow up.
次要结局
- Percentage of Participants Receiving Macugen Monotherapy Versus Those Receiving a Combination Therapy(12 months or last follow-up visit before study termination)
- Percentage of Participants Showing Improvement in Optical Coherence Tomography (OCT) Parameters(12 months or last follow-up visit before study termination)
- Percentage of Participants Showing Improvement in Fundus Fluorescein Angiography (FFA) Parameters(12 months or last follow-up visit before study termination)
- Percentage of Participants With Early Lesions Showing Stabilization and Improvement of VA(12 months or last follow-up visit before study termination)
- Average Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions(12 months or last follow-up visit before study termination)
- Median Number of Injections to Achieve Stabilization of VA in Participants With Early Lesions(12 months or last follow-up visit before study termination)
- Percentage of Participants With Occult or Minimally Classic and Classic Lesions Showing Stabilization and Improvement in VA(12 months or last follow-up visit before study termination)
- Percentage of Participants Who Were Treatment Naive When Started on Macugen Versus Those Previously Treated by Any Other Therapy Except Macugen(12 months or last follow-up visit before study termination)
- Percentage of Participants Showing Stabilization or Improvement in VA in the Subgroup Previously Treated by Other Therapy(12 months or last follow-up visit before study termination)
- Percentage of Participants Showing Improvement in OCT in the Subgroup Previously Treated by Other Therapy(12 months or last follow-up visit before study termination)
- Percentage of Participants Showing Improvement in OCT in the Subgroup Which Were Not Treatment Naive(12 months or last follow-up visit before study termination)