A Multicenter, Randomized, Single-masked Study Comparing Reduced-fluence Visudyne®-Lucentis® Combination Therapies and Lucentis® Monotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to AMD.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- QLT Inc.
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Mean Number of Retreatments (Day 0 Excluded)
研究概览
简要总结
The objective of this study is to determine if combination therapy (reduced-fluence Visudyne followed by Lucentis [within 2 hours] or either of two regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy [within 2 hours]) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment naive for choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye except for laser treatment outside the subfoveal area
- •Subfoveal CNV due to AMD
- •CNV must be = or >50 % of the entire lesion
- •All lesion composition types with a lesion greatest linear dimension (GLD) < 5400 microns (approximately = or <9 disc areas [DA])
- •Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA score) of 25 - 73 letters (approximate Snellen equivalent of 20/40 - 20/320), inclusive
排除标准
- •Subfoveal geographic atrophy or subfoveal fibrosis of the study eye
- •Intraocular surgery within 3 months of enrollment
- •Inability to attend the protocol-required visits
- •Known allergies or hypersensitivity to any of the study treatments.
- •Other systemic diseases or active uncontrolled infections that would make subject a poor medical risk
- •Uncontrolled glaucoma, defined as (1)subject is on >1 glaucoma medication (includes combination treatments) or (2)subject has glaucoma that could lead to progressive visual field deterioration
- •If subject has had a stroke within the last year
研究组 & 干预措施
1/4 Fluence Triple Therapy
Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
干预措施: verteporfin (Drug)
1/4 Fluence Triple Therapy
Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
干预措施: ranibizumab (Drug)
1/4 Fluence Triple Therapy
Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
干预措施: dexamethasone (Drug)
1/2 Fluence Triple Therapy
Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
干预措施: verteporfin (Drug)
Ranibizumab
Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter
干预措施: ranibizumab (Drug)
1/2 Fluence Triple Therapy
Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
干预措施: ranibizumab (Drug)
1/2 Fluence Triple Therapy
Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
干预措施: dexamethasone (Drug)
1/2 Fluence Double Therapy
Reduced-fluence Visudyne followed by Lucentis double therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
干预措施: verteporfin (Drug)
1/2 Fluence Double Therapy
Reduced-fluence Visudyne followed by Lucentis double therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
干预措施: ranibizumab (Drug)
结局指标
主要结局
Mean Number of Retreatments (Day 0 Excluded)
时间窗: Month 1 to Month 12
Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.
Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)
时间窗: Baseline to Month 12
Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100
次要结局
- Mean Number of Retreatments (Day 0 Excluded)(Month 1 to Month 24)
- Mean Change From Baseline in Study Eye Best-Corrected VA Score(Baseline to Month 24)
- Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline(Baseline to Month 12, Baseline to Month 24)
- Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline(Baseline to Month 12, Baseline to Month 24)
- Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline(Baseline to Month 12, Baseline to Month 24)
- Mean Change From Baseline in Central Retinal Thickness(Baseline to Month 12, Baseline to Month 24)
- Mean Change From Baseline in Lesion Size(Baseline to Month 12, Baseline to Month 24)