Multi-Center, Randomized, Phase II Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide and Avastin® in Combination With Photodynamic Therapy in Participants With Neovascular Age Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 22
- 主要终点
- The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12
研究概览
简要总结
VERTACL will investigate whether a triple therapy, Avastin®, half fluence verteporfin photodynamic therapy (PDT), and triamcinolone acetonide-preservative free (TAC- PF), results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD.
详细描述
The VERTACL study is a multi-center, randomized, Phase II trial to investigate whether a triple therapy, Avastin®, half fluence verteporfin PDT, and TAC- PF, results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD.
Participants will be randomized (similar to the flip of a coin) in a 1:1 ratio to one of the two study groups: single therapy (Avastin®), or triple therapy (Avastin®, half fluence verteporfin PDT, and TAC- PF). Participants in the Avastin® alone arm will receive 1.25 mg intravitreal Avastin®, at every study visit. Participants in the triple-therapy arm will receive all treatments (Avastin®, half fluence verteporfin PDT, and TAC- PF) at baseline.
Following baseline, participants in the triple therapy study arm will receive study treatment on an as-needed (PRN) basis if protocol-specific re-treatment criteria are met. After randomization, participants will return to the clinic approximately every six weeks for one year for study assessments and possible re-treatment.
Participants will return to the clinic at month 24 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography, and fundus photography.
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
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12
次要结局
- Mean and median change in ETDRS BCVA from baseline to months 3, 6, and 24.
- Proportion of participants avoiding a loss of ³ 15 letters in ETDRS BCVA by months 3, 6, 12, and 24
- Proportion of participants improving by ³ 15 letters in ETDRS BCVA at months 3, 6, 12, and 24.
- Proportion of participants who show any improvement in ETDRS BCVA at months 3, 6, 12, and 24.
- Mean change in the total lesion area (Disc Areas) from baseline to months 3, 6, 12, and 24.
- Mean change in area of CNV (Disc Areas) at months 3, 6, 12, and 24.
- Mean change in area of leakage (Disc Areas) at months 3, 6, 12, and 24.
- Proportion of classic CNV out of the entire lesion from baseline to months 3, 6, 12, and 24.
- Changes in mean excess retinal thickening in the center subfield (i.e., thickness >175 microns) from baseline to months 3, 6, 12, and 24.
- Proportion of participants with reduction in retinal thickening in the center subfield (i.e., thickness > 175 microns) of ³50% and of at least 50 microns from baseline to months 3, 6, 12, and 24.
- The overall probability of re-injection (excluding injections precluded for safety concerns) through Month 12.
- The mean number of injections by quarter on study following initial induction injections.