A Single-center, Open-label Study Evaluating the Impact of Repeat Intravitreal Injections of Aflibercept on Capillary Non-Perfusion (CNP) in Subjects With Proliferative Retinopathy and/or Macular Edema Secondary to Proliferative Diabetic Retinopathy and Central Retinal Venous Occlusive Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mean Change in Capillary Non-Perfusion
研究概览
简要总结
The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or Proliferative Diabetic Retinopathy (PDR).
详细描述
Protocol available upon request.
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
- •Diagnosis of one or more of the following:
- •Proliferative retinopathy (PDR) Macular edema secondary to CRVO Proliferative disease secondary to CRVO (anterior segment or posterior segment neovascularization).
- •Be in need of IAI treatment, whether previously treated or treatment-naïve.
- •Age > 18 years.
排除标准
- •Subjects with macular edema secondary to diabetic retinopathy without concomitant proliferative diabetic retinopathy.
- •Subjects with cataract or other media opacities impairing adequate visualization of the retina to the extent that good quality images are impossible.
- •Presence of any substantial ocular disease (other than diabetic retinopathy or central retinal vein occlusion) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
- •Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
- •Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication).
- •History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
- •Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study.
- •Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline.
- •History of vitrectomy surgery in the study eye.
- •Subjects with 12 or more anti-VEGF injections within 24 months prior to Screening.
- •Subjects who received anti-VEGF therapy within 30 days of Screening or received steroid or laser therapy within 90 days of Screening.
- •Subjects allergic to fluorescein, povidone iodine (Betadyne) or aflibercept
- •Pregnant or breast-feeding women.
研究组 & 干预措施
Every Month Treatment
Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study.
干预措施: Intravitreal Aflibercept Injection (Drug)
Every Month, then Every Other Month
Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the first 6 months, then every other month for the next 6 months. Retreatment criteria will allow for patients to be treated every month in the second 6 months if needed.
干预措施: Intravitreal Aflibercept Injection (Drug)
结局指标
主要结局
Mean Change in Capillary Non-Perfusion
时间窗: 12 months
To determine mean change in the presence and amount of capillary non-perfusion as measured by wide-angle angiography using Optos 200Tx system at Baseline, Month 3, Month 6, and Month 12.
次要结局
未报告次要终点