Intravitreal Aflibercept Injection as a Surgical Adjuvant in Severe Proliferative Diabetic Retinopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Rate of Resolved Post-operative Vitreous Hemorrhage.
研究概览
简要总结
To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.
详细描述
Patients who need Pars Plana Vitrectomy surgery, and agree to participate in this study will receive an injection of 2.0mg aflibercept 4 to 6 days before Vitrectomy surgery. Half of these patients will be randomized to receive another injection of 2.0mg aflibercept immediately after their surgery. Postoperative patient visits in this study will be at 1 day, and at weeks 1, 4, 16 and 24, and at any other times as deemed necessary by the Investigator.
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
- 18 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 > 18 years
- •Diagnosed with proliferative diabetic retinopathy (PDR) requiring pars plana vitrectomy (PPV)
- •Best corrected visual acuity in the study eye between 20/40 to light perception (LP) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart
排除标准
- •Pregnancy (positive urine 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 intrauterine device (IUD), or contraceptive hormone implant or patch.
- •Participation in a study of an investigational drug or device within the past 30 days prior to enrolling in the study
- •For previously treated subjects -
- •Prior treatment with anti-vascular endothelial growth factor (anti-VEGF) therapy in the study eye within 28 days of Screening
- •Prior treatment with triamcinolone in the study eye within 6 months of Screening.
- •Prior treatment with dexamethasone in the study eye within 30 days of Screening
- •Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Baseline
- •History of vitrectomy surgery, submacular surgery, or other surgical intervention for PDR in the study eye
- •Active intraocular inflammation (grade trace or above) in the study eye
- •History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) ≥ 30 mmHg despite treatment with anti-glaucoma medication)
- •History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 6 months of study enrollment.
- •History of allergy to fluorescein, indocyanine green (ICG) or iodine, not amenable to treatment
- •Presence of macular traction
- •Uncontrolled hypertension (e.g., 120/200 mmHg) prior to surgery (PPV)
- •Concomitant use of any systemic anti-VEGF therapy
研究组 & 干预措施
Vitrectomy with Aflibercept Injection
Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection.
干预措施: Intravitreal Aflibercept Injection (Drug)
Standard Vitrectomy
Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
干预措施: Standard Vitrectomy (Other)
结局指标
主要结局
Rate of Resolved Post-operative Vitreous Hemorrhage.
时间窗: 24 weeks
Percentage of patients who had no vitreous hemorrhage before or at week 24
次要结局
- Mean Change in Visual Acuity(24 weeks)
- Need for Any Additional Surgical Intervention.(24 weeks)
- Changes in Mean Central Retinal Thickness.(24 weeks)