Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Severity of Adverse Events
研究概览
简要总结
This 52 week study will assess the use of intravitreal aflibercept injections in patients with neovascular glaucoma (NVG) compared to standard of care panretinal photocoagulation.
The investigators hypothesize that the neovascularization of the iris and angle present in neovascular glaucoma will resolve more quickly in eye treated with intravitreal aflibercept injection alone and result in increased comfort and preservation of visual field as compared to current standard of care utilizing pan-retinal photocoagulation. The advantages to intravitreal aflibercept injection use could include resolution of NVI/NVA (neovascularization of the iris/neovascularization of the angle) leading to quicker pain relief and quicker lowering of IOP (intraocular pressure).
详细描述
The two arms of this study will compare current common practice (initial intravitreal anti-VEGF (vascular endothelial growth factor) to study treatment (VEGF) injection only) for 52 weeks.
This single center study will consist of 20 patients with NVG. Patients will be randomized to:
- Group A: A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks.
or
- Group B: 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of neovascular glaucoma (Stage I-II)
- •Individuals who are ages 21-90 years old; male or female of any race
- •Presence of neovascularization of the iris and/or angle
- •At least 90 degrees of "unzipped" anterior chamber angle as noted by gonioscopy. (a "zipped angle is the term used for a drainage angle that is slowly closing due to scar tissue from the neovascularization process)
- •Visual acuity of light perception or better in the study eye
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •Use of intravitreal anti-VEGF agents in the study eye in the past 3 months.
- •Full PRP in the study eye
- •Prior vitrectomy in the study eye
- •Prior trabeculectomy or other filtration surgery in the study eye
- •Active ocular or periocular infection in the study eye
- •Ocular conditions (Cataract or vitreous hemorrhage) that might require surgery in next 12 months
- •Allergy to fluorescein dye
- •Any past use of systemic anti-VEGF medication
- •Myocardial infarction within 6 months prior to study enrollment
- •Stroke within 6 months prior to study enrollment
- •Pregnant or breast-feeding women
- •Sexually active men or women of childbearing potential who are unwilling to practice adequate contraception during the study
研究组 & 干预措施
Aflibercept with Laser
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
干预措施: Aflibercept (Drug)
Aflibercept
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
干预措施: Aflibercept (Drug)
结局指标
主要结局
Severity of Adverse Events
时间窗: 2 year
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events
Incidence of Adverse Events
时间窗: 2 year
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events
次要结局
- Intraocular Pressure (mmHg) at Week 52(Week 52)
- Visual Acuity at Week 52(Week 52)
- Number of Patients With Need for Surgical Intervention(1 year)
- Rate and Extent of Resolution of Neovascularization(1 year)
- Intraocular Pressure (mmHg) at Baseline(Baseline)
- Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B(Baseline to Week 52)
- Extent of Resolution of Neovascularization Between Groups(1 year)
- Evaluation of the Average Retinal Nerve Fiber Layer (RNFL)(1 year)
- Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity(Baseline to Week 52)
- Visual Acuity at Baseline(Baseline)
- Measure of the Optical Coherence Tomography(OCT) Outcomes(Baseline to Week 52)
- Comparison of the Visual Field Between Groups(1 year)
- Number of Participants With Need for Additional IOP Lowering Medications(1 year)