Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 271
- 主要终点
- Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
研究概览
简要总结
This study is conducted in 3 stages. Stage 1 is an open-label, dose-escalation assessment of the safety of AGN-150998 administered as a single intravitreal injection to patients with advanced exudative Age-related Macular Degeneration (AMD). Stage 2 and Stage 3 are randomized, double-masked, comparisons of the safety and treatment effects on retinal edema and best-corrected visual acuity (BCVA) of AGN-150998 and ranibizumab in treatment-naive patients with exudative AMD. Study medication is administered as needed in Stage 2 and with a fixed-dosing schedule in Stage 3. The study objectives are (1) to identify the highest tolerated dose of AGN-150998, (2) to assess the safety and duration of treatment effects on retinal edema and BCVA, and (3) to characterize the systemic pharmacokinetic profile of AGN-150998.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Exudative age-related macular degeneration
- •Best-corrected visual acuity between 20/32 and 20/320 in the study eye
排除标准
- •Near-sightedness of 8 diopters or more
- •Uncontrolled glaucoma in the study eye
- •Cataract surgery or Lasik within the last 3 months
- •Any active ocular infection or inflammation
研究组 & 干预措施
Stage 1: AGN-150998 4.2 mg
Stage 1: AGN-150998 4.2.mg given as a single intravitreal injection.
干预措施: AGN-150998 (Drug)
Stage 1: AGN-150998 3.0 mg
Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
干预措施: AGN-150998 (Drug)
Stage 1: AGN-150998 2.0 mg
Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
干预措施: AGN-150998 (Drug)
Stage 1: AGN-150998 1.0 mg
Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
干预措施: AGN-150998 (Drug)
Stage 2: AGN-150998 4.2 mg
Stage 2: AGN-150998 4,2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
干预措施: AGN-150998 (Drug)
Stage 2: AGN-150998 3.0 mg
Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose) from Stage 1 given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
干预措施: AGN-150998 (Drug)
Stage 2: ranibizumab 0.5 mg
Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
干预措施: ranibizumab (Drug)
Stage 3: AGN-150998 2.0 mg
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
干预措施: AGN-150998 (Drug)
Stage 3: AGN-150998 2.0 mg
Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
干预措施: Sham Injection (Other)
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
干预措施: AGN-150998 (Drug)
Stage 3: AGN-150998 1.0 mg
Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
干预措施: Sham Injection (Other)
Stage 3: ranibizumab 0.5 mg
Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
干预措施: ranibizumab (Drug)
结局指标
主要结局
Stage 1: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
时间窗: Baseline, Week 4
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Stage 3: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
时间窗: Baseline, Week 16
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Highest Tolerated Dose (HTD) of AGN-150998
时间窗: 24 Weeks
Stage 1 evaluated the safety of a single intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
Stage 2: Time Between Baseline Treatment and Recurrence of Active Disease
时间窗: Baseline, Week 16
Recurrence of Active Disease was based on Best Corrected Visual Acuity (BCVA), Central Retinal Thickness (CRT) values as evaluated by the Central Reading Center (CRC) and the investigator assessments of haemorrhage.
次要结局
- Stage 2: Time Between Second Treatment and Recurrence of Active Disease(32 Weeks)
- Stage 2: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye(Baseline, Week 4)
- Stage 2: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye(Baseline, Week 4)
- Stage 3: Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye(Baseline, Week 4)
- Stage 3: Change From Baseline in BCVA in the Study Eye(Baseline, Week 4)