Mirabegron in Patients With Age-Related Macular Degeneration Treated for Overactive Bladder: A Study Protocol for a Non-Randomized Prospective Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Changes in outer retinal morphology using SD-OCT
研究概览
简要总结
The goal of this clinical trial is to learn if Mirabegron works to treat dry AMD in patients, aged between 50 and 80 years-old, with early or moderate dry AMD and overactive bladder.
The main question it aims to answer is:
• Is there any change in outer retina morphology in patients treated?
Researchers will compare the safety and efficacy of mirabegron versus conventional approach (Solifenacin) to treat dry AMD in patients with dry AMD and overactive bladder.
Participants will:
- Take Mirabegron or Solifenacin every day for 12 months
- Visit the clinic once every 6 months for checkups and tests
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age subjects 50 and 80 years-old
- •Ability to express informed consent
- •Early or moderate dry AMD according to ARDS classification
- •Overreactive bladder
- •Visual acuity greater than BCVA 65 EDTRS letters.
排除标准
- •• Any medical condition which contraindicates the use of beta-agonists
- •Uncontrolled hypertension
- •Tachycardia or atrial fibrillation
- •Any allergies to the beta-agonists
- •Renal or hepatic failure
- •Long QT or concomitant treatment with drugs that cause lengthening of the QT interval
- •Any sign of ocular inflammation
- •xudative AMD
- •Any ongoing medical or surgical treatment for AMD (including intravitreal injections, oral supplementation of lutein, zeaxanthin and or high dietary intake of antioxidants)
- •Any other ophthalmic diseases such glaucoma, acute or chronic uveitis, advanced cataract, or any opacities of the ocular media that do not permit high-quality imaging examinations.
- •Pregnancy
- •Any condition or disease that in the opinion of the investigators may put the subject at significant risk or may interfere significantly with the subject's participation in the study (i. e. malignancy, uncontrolled or cardiovascular diseases)
研究组 & 干预措施
Mirabegron arm
Mirabegron will be administered per os at the dose of 50 mg/day for 12 months
干预措施: Mirabegron 50mg (Drug)
Control arm
Solifenacin will be administered per os at the dose of 5mg/day for 12 months
干预措施: Solifenacin 5mg (Drug)
结局指标
主要结局
Changes in outer retinal morphology using SD-OCT
时间窗: "From enrollment to the end of treatment at 12 months
Outer nuclear layer (ONL) thickness, choroidal thickness (ChT), central macular thickness (CMT) will all be measured in micron
Changes in FAF assessing
时间窗: "From enrollment to the end of treatment at 12 months
changes in FAF measured in micron
次要结局
- mean BCVA(From enrollment to the end of treatment at 12 months)
- Mean macular sensitivity (MS)(From enrollment to the end of treatment at 12 months)
研究者
Mario Damiano Toro
Principal Investigator, MD, PhD
University of Naples