A Phase III Randomized 1:1, Masked, Study of the Safety, Tolerability, and Efficacy of Intravitreal Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Adjuvant Management of TRD and Vit Hem Associated With PDR
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Tractional Retinal Detachment Repair
研究概览
简要总结
The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment.
详细描述
Patients undergoing pars plana vitrectomy for active PDR with TRD will receive a single intravitreal pre-operative 0.3mg Macugen™ prior to surgery versus sham injection.
Specific timing of the injection will be at no sooner than 7 days and no longer than 14 days prior to surgery.
Patients will receive a preinjection fundus photo and another post injection photo the day of surgery as dictated by the operative schedule.
Some photos may be limited secondary to vitreous hemorrhage. Follow up visits after surgery will be one day, one week, one month, and three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Best corrected visual acuity in the study eye between 20/30 and light perception (LP)
- •Willingness to provide signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- •Age ≥ 18 years
- •For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study
排除标准
- •History of anti-VEGF treatment in the study eye
- •History of previous pars plana vitrectomy in the study eye
- •Intraocular surgery in the study eye within one month of the study
- •Patients with extensive vitreous hemorrhage in conjunction with a rhegmatogenous retinal detachment
- •Tractional retinal detachment from causes inconsistent with PDR, such as inflammation or trauma
- •Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition or if allowed to progress untreated could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the study period.
- •Active intraocular inflammation (grade trace or above) in the study eye
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Uncontrolled glaucoma in the study eye (defined as IOP≥ 35 mmHg despite treatment with anti-glaucoma medication)
- •History of glaucoma-filtering surgery in the study eye
- •History of corneal transplant in the study eye
研究组 & 干预措施
0.3mg Pegaptanib Sodium, Macugen
will receive Macugen intravitreal injection prior to surgery
干预措施: Macugen (Drug)
Sham injection
will receive a sham injection
干预措施: Sham (Drug)
结局指标
主要结局
Tractional Retinal Detachment Repair
时间窗: 6 months
Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire.
次要结局
- Adverse Events(6 months)
- Visual Acuity(6 months)
- Post surgical interventions(6 Months)
- Vitreous Hemorrhage and Tractional Retinal Detachment Improvement(6 months)
研究者
James C. Major, PhD, MD
Principal Investigator
Greater Houston Retina Research