An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 608
- 主要终点
- Number of Participants With Ocular Adverse Events in the Study Eye
研究概览
简要总结
This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the previous study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent form
- •The 6-month treatment and 6-month observation phases (12 months total) of a Genentech-sponsored ranibizumab study for RVO (FVF4165g or FVF4166g)
- •Expectation by the investigator that the subject may potentially benefit from intravitreal anti-vascular endothelial growth factor (VEGF) treatment
排除标准
- •History of intraocular surgery (including cataract extraction, scleral buckle, etc.) within 1 month prior to Day 0 of this extension study
- •Concurrent use of systemic anti-VEGF agents
- •Use of RVO treatments not approved by the Food and Drug Administration (FDA) in the study eye
- •Use of intravitreal bevacizumab in the study eye and/or fellow eye
- •Macular edema in the study eye due to other causes than RVO such as diabetes
- •History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- •History of idiopathic or autoimmune-associated uveitis in either eye
- •Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 30 mmHg despite treatment with antiglaucoma medication)
- •Pregnancy or lactation
- •Premenopausal women not using adequate contraception
- •History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
- •Current treatment for active systemic infection
- •Inability to comply with study or follow-up procedures
研究组 & 干预措施
Ranibizumab 0.5 mg
Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months.
干预措施: Ranibizumab 0.5 mg (Drug)
结局指标
主要结局
Number of Participants With Ocular Adverse Events in the Study Eye
时间窗: Up to 24 months
Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.
Number of Participants With Non-ocular Adverse Events
时间窗: Up to 24 months
Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death. Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded. Additional information about adverse events can be found in the adverse events section.
次要结局
- Change From Baseline in the Best Corrected Visual Acuity (BCVA)(Baseline (Day 0 of extension study), Months 6, 12, 18, and 24)
- Change From Baseline in Central Foveal Thickness at Month 6 and Month 12(Baseline (Day 0 of extension study), Months 6 and 12)
- Change From Baseline in Visual Function Composite Score, as Measured by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25)(Baseline (Day 0 of extension study), Months 12 and 24)