MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops Versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 510
- 试验地点
- 1
- 主要终点
- Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of different dosage regimens of pazopanib eye drops for the treatment of neovascular age-related macular degeneration.
详细描述
MD7110852 is a Phase 2b dose-ranging study designed to demonstrate the 1 year efficacy and safety of pazopanib eye drops for the treatment of neovascular age related macular degeneration (AMD) in subjects whose disease is currently managed with anti-VEGF (vascular endothelial growth factor) injection therapy. Eye drop regimens are double-masked with placebo eye drops and will have access to open-label ranibizumab intravitreal (IVT) injection if needed. The ranibizumab IVT injection every 4 weeks control arm is open-label.
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
- •Men and women aged ≥50 years.
- •Active subfoveal choroidal neovascularization (CNV) lesion secondary to AMD in study eye: Total lesion area ≤12 disc areas with CNV ≥50% total lesion area.
- •Anti-Vascular endothelial growth factor (VEGF) intravitreal injection experienced and in need of re-treatment.
- •Best-corrected visual acuity of at least 24 letters (equates to approximately 20/320 Snellen equivalents or better).
排除标准
- •Prior ocular investigational drug/device for choroidal neovascularization, photodynamic therapy, radiation, subfoveal or juxtafoveal focal laser photocoagulation.
- •Prior failure to anti-VEGF intravitreal injection therapy.
- •Recent ocular investigational drug/device for non-CNV condition.
- •Prior ocular surgeries (vitrectomy, scleral buckle, or glaucoma filtering/shunt surgery). Cataract surgery permitted if ≥3 months and has posterior chamber intraocular lens.
- •Center-fovea involvement of any of the following: fibrosis, atrophy, serous retinal pigment epithelial detachment, or retinal pigment epithelial tear.
- •CNV in either eye due to other causes.
- •Clinical evidence of diabetic retinopathy or diabetic macular edema.
- •Recent myocardial infarction or cerebrovascular accident.
- •Uncontrolled hypertension in spite of antihypertensive medications.
研究组 & 干预措施
investigational arm 1
5 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection
干预措施: pazopanib eye drops (Drug)
investigational arm 2
5 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection
干预措施: pazopanib eye drops (Drug)
investigational arm 3
10 mg/mL pazopanib eye drops BID with allowance for as-needed ranibizumab injection
干预措施: pazopanib eye drops (Drug)
investigational arm 4
10 mg/mL pazopanib eye drops TID with allowance for as-needed ranibizumab injection
干预措施: pazopanib eye drops (Drug)
investigational arm 5
10 mg/mL pazopanib eye drops QID with allowance for as-needed ranibizumab injection
干预措施: pazopanib eye drops (Drug)
placebo control arm
Placebo eye drops QID with allowance for as-needed ranibizumab injection
干预措施: placebo (Drug)
active open-label control arm
Ranibizumab intravitreal injection every 4 weeks
干预措施: ranibizumab intravitreal injection (Biological)
结局指标
主要结局
Change From Baseline in Best-corrected Visual Acuity (BCVA) as Measured by the Number of Letters Read on the Early Treatment of Diabetic Retinopathy Study (ETDRS) Grading Charts at a Starting Distance of 4 Meters at Week 52
时间窗: Day 1 and 52 weeks
BCVA was measured in the study eye using the ETDRS grading charts starting at a test distance of 4 meters. The ETDRS grading chart was of at least 24 to 78 letters. 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. There were seven cut off points in change from baseline visual acuity on ETDRS grading chart which are, 15 to 29, 10 to 14, 5 to 9, -4 to 4, -5 to -9, -10 to -14 and -15 to -29 letters. The change from baseline was calculated by subtracting the baseline values from the individual post-randomization values. If either the baseline or post-randomization value was missing, the change from baseline was set to missing as well. Day 1 values are considered as Baseline in this study.
次要结局
- Percentage of Ranibizumab Re-injections Received Over 28 and 52 Weeks(Up to 52 weeks)
- Summary of Intraocular Pressure Exam Findings(Up to week 52)
- Number of Participants With BCVA Over Time(Up to Week 52)
- Number of Participants Analyzed for Visual Acuity (VA) Response Over Time(Week 52)
- Number of Participants That Met Criteria for Re-injection(Up to Week 52)
- Change From Baseline in the Area of Choroidal Neovascularisation (CNV)(Day 1, Week 28 and Week 52)
- Change From Baseline in the Area of the CNV Lesion Complex (i.e. CNV, Blood, PED, and Fibrosis)(Day 1, Week 28 and Week 52)
- Change From Baseline in Center Point Thickness (CPT) Over Time(Baseline and Week 52)
- Change From Baseline in the Area of Fluorescein Leakage(Day 1, Week 28 and Week 52)
- Change in Area of Serous Sensory Retinal Detachment (SSRD)(Day 1, Week 28 and Week 52)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 52 Weeks)
- Summary of Potentially Clinically Important Findings for Ophthalmic Examinations(Up to Week 52)
- Number of Participants With Vital Sign Values Outside of Clinical Concern Range(Up to Week 52)
- Summary of Abnormal Electrocardiogram (ECG) Findings(Week 4, Week 28, Week 44 and Week 52)
- Summary of Hematology and Clinical Chemistry Parameters Data of Clinical Concern(Up to Week 52)
- Number of Participants With Laboratory Data of Clinical Concern for Urine Protein(Day 1 to Week 28 and Week 52)
- Plasma Concentrations of Pazopanib(Week 4, Week 24 and Week 52)