Prospective Optical Coherence Tomography (OCT) Imaging of Patients With Neovascular AMD Treated With Intra-Ocular Ranibizumab (Lucentis) (PrONTO) Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in visual acuity vs baseline
研究概览
简要总结
This study was designed to evaluate a variable dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD) in the Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular Ranibizumab (PrONTO) study.
详细描述
In this 2-year open-label, prospective, single-center, uncontrolled, investigator sponsored clinical study, neovascular AMD patients with subfoveal CNV (N=40) and a central retinal thickness of at least 300 µm as measured by optical coherence tomography (OCT) were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes were observed between visits: a loss of 5 letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 μm, new onset classic CNV, new macular hemorrhage, or persistent macular fluid following an injection of ranibizumab at the prior study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 or older
- •Active primary or recurrent macular neovascularization secondary to age-related macular degeneration (AMD) involving the central fovea in the study eye with evidence of disease progression
- •OCT central retinal thickness ≥ 300 microns
- •Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/400 (Snellen equivalent) in the study eye
排除标准
- •More than 3 prior treatments with verteporfin photodynamic therapy
- •Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors)
- •Previous subfoveal focal laser photocoagulation in the study eye
- •Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0
- •Subfoveal fibrosis or atrophy in the study eye
- •History of vitrectomy surgery in the study eye
- •Aphakia or absence of the posterior capsule in the study eye
- •History of idiopathic or autoimmune-associated uveitis in either eye
结局指标
主要结局
Change in visual acuity vs baseline
Change in OCT central retinal thickness vs baseline
次要结局
- Number of injections over 1 year
- Number of consecutive monthly injections until fluid-free
- Injection free interval
- Correlations of injection frequency with baseline lesion characteristics and visual acuity
研究者
Philip J. Rosenfeld, MD, PhD
Professor of Ophthalmology
University of Miami