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临床试验/NCT01245387
NCT01245387已完成不适用

Long-Term Non-Interventional Study (AB Study) To Investigate The Efficacy And Safety Of Macugen® In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice

Pfizer0 个研究点目标入组 1,001 人开始时间: 2006年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Pfizer
入组人数
1,001
主要终点
Visual Acuity (VA)

研究概览

简要总结

Long-term observational study to assess the safety, efficacy and quality of life of patients with neovascular age-related macular degeneration (AMD) under Macugen treatment.

详细描述

Ophthalmologists who are experienced in doing intravitreal injections in Germany

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

入选标准

  • patients with neovascular age-related macular degeneration

排除标准

  • 未提供

研究组 & 干预措施

Macugen

干预措施: Pegaptanib (Drug)

结局指标

主要结局

Visual Acuity (VA)

时间窗: Baseline, every 6 weeks up to Month 24 or early termination

VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study \[EDTRS\]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).

Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score

时间窗: Baseline, every 6 months up to Month 24 or early termination

Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.

Number of Participants With Investigator Assessments of Efficacy

时间窗: Month 24 or early termination

Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.

Lesion Size (Number of Optic Disc Areas)

时间窗: Baseline, every 6 weeks up to Month 24 or early termination

Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm\^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).

Number of Participants With a Change in Activity of Neovascular Membrane at Week 6

时间窗: Week 6

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Week 12

时间窗: Week 12

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Week 18

时间窗: Week 18

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Week 24

时间窗: Week 24

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Week 30

时间窗: Week 30

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Week 36

时间窗: Week 36

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Week 42

时间窗: Week 42

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Week 48

时间窗: Week 48

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Week 54

时间窗: Week 54

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Week 60

时间窗: Week 60

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Week 66

时间窗: Week 66

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Week 72

时间窗: Week 72

Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.

Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit

时间窗: Month 24 or early termination

Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.

Number of Participants With Pigment Epithelial Detachment (PED) at Baseline

时间窗: Baseline

PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

Number of Participants With PED at Week 6

时间窗: Week 6

PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

Number of Participants With PED at Week 12

时间窗: Week 12

PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

Number of Participants With PED at Week 18

时间窗: Week 18

PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

Number of Participants With PED at Week 24

时间窗: Week 24

PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

Number of Participants With PED at Week 30

时间窗: Week 30

PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

Number of Participants With PED at Week 36

时间窗: Week 36

PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

Number of Participants With PED at Week 42

时间窗: Week 42

PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

Number of Participants With PED at Week 48

时间窗: Week 48

PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

Number of Participants With PED at Week 54

时间窗: Week 54

PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.

Number of Participants With PED at Last Visit

时间窗: Month 24 or early termination

PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.

Central Retinal Thickness

时间窗: Baseline, every 6 weeks up to Month 24 or early termination

Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).

Number of Participants With Angiographic Subtype Reported at Baseline

时间窗: Baseline

Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

Number of Participants With Angiographic Subtype Reported at Week 6

时间窗: Week 6

Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

Number of Participants With Angiographic Subtype Reported at Week 12

时间窗: Week 12

Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

Number of Participants With Angiographic Subtype Reported at Week 18

时间窗: Week 18

Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

Number of Participants With Angiographic Subtype Reported at Week 24

时间窗: Week 24

Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

Number of Participants With Angiographic Subtype Reported at Week 30

时间窗: Week 30

Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

Number of Participants With Angiographic Subtype Reported at Week 36

时间窗: Week 36

Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

Number of Participants With Angiographic Subtype Reported at Week 42

时间窗: Week 42

Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

Number of Participants With Angiographic Subtype Reported at Week 48

时间窗: Week 48

Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

Number of Participants With Angiographic Subtype Reported at Week 54

时间窗: Week 54

Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).

Number of Participants With Angiographic Subtype Reported at Last Visit

时间窗: Month 24 or early termination

Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.

次要结局

未报告次要终点

研究者

发起方
Pfizer
申办方类型
Industry

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