A Combined Phase IIa / IIb Study of the Efficacy, Safety, and Tolerability of Repeated Topical Doses of Regorafenib Eye Drops, in Treatment-naïve Subjects With Neovascular Age Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 52
- 主要终点
- Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Study Week 4 for Study Part A
研究概览
简要总结
Part A (Phase IIa):
Primary objectives:
The study part A is designed to investigate whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study.
Secondary objectives:
The study will also evaluate the safety and tolerability of the regorafenib eye drops.
Part B (Phase IIb):
Primary objectives:
The study part B is designed to investigate:
- how often the regorafenib eye drops need to be given per day
- whether the use of regorafenib eye drops can help patients with neovascular (wet) Age-Related Macular Degeneration (wAMD) to see better after 4 weeks and 12 weeks after inclusion into this study.
Secondary objectives:
The study will also evaluate how the different dosings of regorafenib eye drops affect patients vision, the safety and the tolerability.
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
- •Able to read (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) and able to understand the informed consent form (ICF)
- •Men and women ≥ 50 years of age
- •Active primary subfoveal CNV (Choroidal neovascularization) lesions secondary to AMD (Age-related macular degeneration), including juxtafoveal lesions that affect the fovea as evidenced by FA (Fluorescein angiography) in the study eye and reviewed by the central reading center
- •The area of CNV must occupy at least 50% of total lesion in the study eye, as determined by FA review at the central reading center
- •Evidence of intraretinal and/or subretinal fluid on OCT (Optical coherence tomography)
- •Early Treatment Diabetic Retinopathy Study BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye
- •Willing, committed, and able to return for all clinic visits and complete all study related procedures
- •Women of childbearing potential and men must agree to use adequate contraception when sexually active. This applies since signing of the ICF until one month after the EOS (end of study) visit. The definition of adequate contraception will be based on the judgment of the investigator.
排除标准
- •Concurrent disease in the study eye, other than AMD (e.g., corneal diseases and dystrophies, conjunctival diseases, eye lid abnormalities, or any other diseases of the cornea and macula, or optic nerve abnormality) that could compromise visual acuity, likely require medical or surgical intervention during the study period, would limit the potential to gain or lose vision during study treatment, or could otherwise confound interpretation of the results
- •Total lesion size (including neovascularization, scar, blood) > 12 disc areas (30.5 mm2) as assessed by FA
- •Only one functional eye, even if that eye is otherwise eligible for the study
- •Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye except dietary supplements or vitamins
- •Prior treatment with any systemic anti-VEGF (Vascular endothelial growth factor) agent
- •Use of systemic or ocular treatment with an investigational drug within 12 weeks prior to start of study treatment
- •Any other condition that would require frequent chronic co-administration of other topical eye medications that would interfere with study drug administration (e.g. contact lens)
- •Symptoms or conditions consistent with contraindications listed in the current local label for ranibizumab
- •Participation in an investigational study within 30 days prior to start of study treatment that involved treatment with any drug (excluding vitamins and minerals) or device
- •Lactating women and women of child-bearing potential with either a positive pregnancy test result or no pregnancy test at screening are excluded. Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential.
研究组 & 干预措施
Ranibizumab
Ranibizumab IVT once every 4 weeks; plus placebo eye drops to match the regorafenib eye drop regimens
干预措施: Ranibizumab (Drug)
Regorafenib [A]
Part A: Patients will receive Regorafenib eye drops
干预措施: Regorafenib, ophthalmic oily suspension (BAY73-4506) (Drug)
Regorafenib [B1]
Part B: Regorafenib eye drops dose 1; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Regorafenib, ophthalmic oily suspension (BAY73-4506) (Drug)
Regorafenib [B1]
Part B: Regorafenib eye drops dose 1; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Sham IVT (Procedure)
Regorafenib [B2]
Part B: Regorafenib eye drops dose 2; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Regorafenib, ophthalmic oily suspension (BAY73-4506) (Drug)
Regorafenib [B2]
Part B: Regorafenib eye drops dose 2; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Sham IVT (Procedure)
Regorafenib [B3]
Part B: Regorafenib eye drops dose 3; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Regorafenib, ophthalmic oily suspension (BAY73-4506) (Drug)
Regorafenib [B3]
Part B: Regorafenib eye drops dose 3; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Sham IVT (Procedure)
Regorafenib [B4]
Part B: Regorafenib eye drops dose 4; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Regorafenib, ophthalmic oily suspension (BAY73-4506) (Drug)
Regorafenib [B4]
Part B: Regorafenib eye drops dose 4; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Sham IVT (Procedure)
Regorafenib [B5]
Part B: Regorafenib eye drops dose 5; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Regorafenib, ophthalmic oily suspension (BAY73-4506) (Drug)
Regorafenib [B5]
Part B: Regorafenib eye drops dose 5; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Sham IVT (Procedure)
Regorafenib [B6]
Part B: Regorafenib eye drops dose 6; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Regorafenib, ophthalmic oily suspension (BAY73-4506) (Drug)
Regorafenib [B6]
Part B: Regorafenib eye drops dose 6; plus sham IVT (Intravitreal therapy) once every 4 weeks
干预措施: Sham IVT (Procedure)
Ranibizumab
Ranibizumab IVT once every 4 weeks; plus placebo eye drops to match the regorafenib eye drop regimens
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Study Week 4 for Study Part A
时间窗: Baseline, Week 4
Participants will be assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS. The participant's ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.
Change From Baseline in BCVA as Measured by ETDRS Letter Score at Study Week 12 for Study Part A
时间窗: Baseline, Week 12
Participants were assessed at each clinic visit for best corrected visual acuity using the early treatment diabetic retinopathy study chart. Visual function of the study eye and the fellow eye was assessed using the ETDRS protocol. ETDRS testing score was recorded in the appropriate eCRF page at each study visit. For participants that dropped out or received rescue treatment the last observation before drop-out or administration of rescue treatment was carried forward. A higher score represents better functioning.
次要结局
- Percentage of Participants With Individual Changes in BCVA of Greater Than Equal to (>=) 0 Letters of Vision From Study Week 4 to Week 12 for Study Part A(Week 4, Week 12)
- Percentage of Participants With a Loss in BCVA of >= 10 Letters From Baseline to Study Week 12 for Study Part A(Baseline, Week 12)