Study Investigating High Resolution OCT, Multifocal ERG and Microperimetry Outcomes of Monthly vs As Needed Ranibizumab in Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Multifocal Electroretinography N1-P1 Amplitude
研究概览
简要总结
Visual outcomes using monthly ranibizumab therapy are well established in clinical trials, but the best way to assess when and how to treat patients with PRN therapy has not been proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with ranibizumab therapy. Additionally, VA and OCT outcomes don't always correlate and other assessments such as the Multi-focal ERG and microperimetry may be useful as early predictors of when patients should be retreated. This study will assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreatment will be based on OCT criteria. We will investigate if microperimetry or multifocal ERG would have been an early predictor of fluid recurrence.
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
- 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
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- •Age greater or equal to 50 years old.
- •Patients with active neovascular AMD
排除标准
- •Pregnancy (Positive pregnancy test) or lactation.
- •Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Participation in another simultaneous medical investigation or trial
- •Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
- •Previous PDT therapy
- •Previous intravitreal steroid therapy within last 3 months
- •Previous anti-VEGF therapy in the past month
研究组 & 干预措施
Monthly
Ranibizumab injections every month for 12 months.
干预措施: OCT, Multifocal ERG, Microperimetry (Device)
Monthly
Ranibizumab injections every month for 12 months.
干预措施: Ranibizumab Ophthalmic (Drug)
As Needed
Ranibizumab injections monthly for 4 months then as needed thereafter.
干预措施: OCT, Multifocal ERG, Microperimetry (Device)
As Needed
Ranibizumab injections monthly for 4 months then as needed thereafter.
干预措施: Ranibizumab Ophthalmic (Drug)
结局指标
主要结局
Multifocal Electroretinography N1-P1 Amplitude
时间窗: One Year
As measured within the central ring of the multifocal electroretinography study this measurement is the difference between the first positive peak (P1) and the first negative peak (N1).
Microperimetry Mean Sensitivity
时间窗: One Year
次要结局
- Best Corrected Visual Acuity(One Year)
- Central Foveal Thickness on Optical Coherence Tomography(One Year)