NCT00546936Unknown2 期
Ranibizumab vs PDT for Presumed Ocular Histoplasmosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Mean change in visual acuity
研究概览
简要总结
The purpose of this study is to evaluate the change in visual activity of ranibizumab to Photodynamic Therapy (PDT)in patients with choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subfoveal CNV due to presumed ocular histoplasmosis of less than 1 year duration
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age greater than or equal to 21 years of age
- •CNV lesion of than < 5400 microns in diameter
- •Best corrected visual acuity of 20/40-20/320
- •Birth control therapy for females of child-bearing potential
排除标准
- •Subfoveal NCV due tp presumed ocular histoplasmosis for > 1 year
- •Pregnancy or lactation premenopausal women not using adequate contraception
- •Prior enrollment in the study
- •Any other condition that the Investigator believes would pose a significant hazard to the subject
- •Participation in another simultaneous medical investigation or trial
- •Participation in another trial or previous trial of ranibizumab or Avastin
- •Any concurrent ocular condition in the study eye (cataract, diabetic retinopathy)that could require medical or surgical intervention or ifa allowed to progress, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period
- •Previous panretinal photocoagulation
- •Previous steroids or PDT in 3 months
- •Previous participation in any studies of investigational drugs within 30 days preceding Day 0
- •Prior participation in a Genentech ranibizumab clinical trial
- •Previous treatment with intravitreally (in either eye) or intravenously administered Avastin within 3 months
- •Previous use of Macugen in the study eye within 3 months
- •Prior submacular surgery
研究组 & 干预措施
ranibizumab intravitreal injection
Experimental
0.5 mg intravitreal injection of ranibizumab
干预措施: ranibizumab (Drug)
Photodynamic Therapy
Active Comparator
Photodynamic therapy with Visudyne
干预措施: verteporfin (Drug)
结局指标
主要结局
Mean change in visual acuity
时间窗: 6 months, 1 year
次要结局
- To evaluate mean change in vision at 6 months(6 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Ranibizumab Supplementing Panretinal Photocoagulation as Treatment for Iris/Angle Neovascularization in Retinal Ischemic DiseaseRetinal IschemiaNCT00841373Southern New England Retina Associates1
已完成
1 期
Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic RetinopathyRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetic RetinopathyNCT01746563University of Sao Paulo30
已完成
4 期
RELAND studyJPRN-jRCTs061180035Kimura Kazuhiro100
已完成
2 期
PRP vs Bevacizumab for PDR TreatmentProliferative Diabetic RetinopathyNCT02705274Marashi Eye Clinic30
Unknown
不适用
Comparison of Intravitreal Ranibizumab and Macular Grid-pattern Laser for Treatment of Diabetic Macular EdemaMacular EdemaNCT00994799Szeged University50