Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF Therapy Comparing Syringe Preparation Time Using Ranibizumab Vial and Pre-filled Syringe
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary outcome measure is mean change in ETDRS BCVA visual acuity
研究概览
简要总结
This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.
详细描述
This is a 24 week, open-label, non-randomized, phase II study evaluating intravitreal ranibizumab dosed every 14 days in subjects with exudative macular degeneration who have persistent intraretinal or subretinal fluid despite chronic monthly anti-VEGF therapy (>6 months). Subjects must have had a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the 6 months preceding enrollment.
Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every 14 days (± 3 days). Subjects who have resolution of fluid will convert to monthly ranibizumab for the remainder of the study. If fluid recurs, subjects will return to biweekly treatment.
Patients will be assigned to receive treatment with either ranibizumab vial or PFSs so that approximately 10 patients will be treated with each delivery method option, and syringe preparation time (SPT) will be measured by an assistant who will be observing the procedure and timing with an automated stopwatch.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age > 50 years
- •Exudative age related macular degeneration in study eye involving the fovea
- •Best Corrected Visual Acuity (by ETDRS) letter score in study eye of < 85 and > 24 (approximate Snellen equivalent 20/20 to 20/320)
- •Persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye
- •At least 30 days from last intravitreal anti-VEGF injection in the study eye
排除标准
- •Patient who are receiving systemic anti-VEGF or proangiogenic therapy
- •Patients on chronic high doses corticosteroid therapy (> than 10 mg of oral prednisone or equivalent greater than 10 days)
- •Patients on chronic immunosuppressant therapy
- •Patients on drugs known to have toxic side effects on the retina e.g. hydroxychloroquine
- •History of intravitreal corticosteroids in study eye within 4 months of baseline
- •Uncontrolled hypertension (defined as systolic >180 mm Hg and/or diastolic > 100 mm Hg while patient is sitting)
- •History of stroke or APTC event in the previous year
- •Any intraocular surgery in study eye within 90 days of baseline
- •Presence of vitreomacular traction in study eye
- •Presence of significant epiretinal proliferation in study eye
- •Evidence of active infection in either eye
- •Uncontrolled glaucoma in the study eye defined as a pressure > 25 mmHg on maximal medical therapy
研究组 & 干预措施
ranibizumab
ranibizumab 0.5mg in commercially available vial
干预措施: Ranibizumab Injection [Lucentis] (Drug)
ranibizumab pre filled-syringe
ranibizumab 0.5mg in soon to be available pre-filled syringe
干预措施: Ranibizumab Injection [Lucentis] (Drug)
结局指标
主要结局
The primary outcome measure is mean change in ETDRS BCVA visual acuity
时间窗: 24 weeks
The primary outcome measure is mean change in ETDRS BCVA visual acuity at 24 weeks compared to baseline.
次要结局
- Proportion of eyes that gain or lose >0 letters at 24 weeks(24 weeks)
- Proportion of eyes that gain or lose > 10 letters at 24 weeks(24 weeks)
- Proportion of eyes that gain or lose > 5 letters at 24 weeks(24 weeks)
- Proportion of eyes that gain or lose > 15 letters at 24 weeks(24 weeks)
- To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting(24 weeks)
- • Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks(24 weeks)
研究者
Andrew N. Antoszyk, MD
Medical Doctor
Southeast Clinical Research Associates, LLC