Correlation of Vascular Endothelial Growth Factor Levels in Anterior Chamber Fluid to Disease State in Patients With Retinal Vein Occlusion Receiving Standard of Care Treatment
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Macular Edema
研究概览
简要总结
The purpose of this study is to treat patients with retinal vein occlusion with standard of care anti-vascular endothelial growth factor therapy and to correlate levels of vascular endothelial growth factor in the anterior chamber fluid of the eye. This study will evaluate if measuring the vascular endothelial growth factor will help predict the timing of when anti-vascular endothelial growth factor therapy will be needed.
详细描述
Ten patients, 5 with branch retinal vein occlusion and 5 with central retinal vein occlusion, will receive stand of care anti-vascular endothelial growth factor over the course of 52 weeks while undergoing a paracentesis prior to each treatment. During the paracentesis anterior chamber fluid will be removed to evaluate vascular endothelial growth factor levels along with other cytokines present in the anterior chamber fluid. Ocular coherence tomography will also be collected at each visit to evaluate macular thickness which will be used to help determine treatment windows along with levels of vascular endothelial growth factor. Patients with high levels of vascular endothelial growth factor and the presence of macular edema on ocular coherence tomography will be treated every four weeks. Once vascular endothelial growth factor levels are reduced along with improvements of macula edema treatment windows will be extended to 8 weeks and then to 12 weeks once levels are normal and edema is no longer present.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Willingness and ability to provide written informed consent.
- •Diagnosis of Retinal Vein Occlusion with macular edema and central foveal thickness of greater than or equal to 300 microns confirmed by intravenous fluorescein angiography and Optical Coherence Tomography
- •Visual Acuity between 20/25 and 5/200
排除标准
- •Bilateral Retinal Vein Occlusion
- •Vision worse than 5/200 in study eye
- •History of myocardial infarction, ischemia, or cerebrovascular accident within 6 weeks of screening
- •Concurrent Proliferative Diabetic Retinopathy and/or Maculopathy
- •Concurrent Exudative Age-related Macular Degeneration
- •Concurrent optic neuropathy with the presence of an afferent pupillary defect
- •Previous vitrectomy in the study eye
- •Currently pregnant or planning to become pregnant during the duration of the study. Women currently breastfeeding are also excluded.
- •Previous treatment for retinal vein occlusion in the study eye
- •Any current medical condition which, in the opinion of the investigator is considered to be uncontrolled
- •History of allergy or hypersensitivity to study treatment, fluorescein, or any study procedure and treatment related ingredients (e.g. topical anesthetics, betadine, etc.)
研究组 & 干预措施
Aflibercept
All subjects will receive aflibercept every 4 weeks. Once vascular endothelial growth factor levels become normal and macular edema improves treatment windows will be extended up to every 12 weeks.
干预措施: Aflibercept Ophthalmic (Drug)
结局指标
主要结局
Change in Macular Edema
时间窗: Baseline through week 35
Measured by central retinal thickness using optical coherence tomography - OCT is an imaging method used to generate a picture of the back of the eye, called the retina. The picture is made by precisely measuring the amount of a dim red light that reflects off the retina
Change in Macular Volume
时间窗: Baseline through week 35
Measured by central retinal thickness using optical coherence tomography - OCT is an imaging method used to generate a picture of the back of the eye, called the retina. The picture is made by precisely measuring the amount of a dim red light that reflects off the retina
Change in Vascular Endothelial Growth Factor (VEGF) Level in Anterior Chamber
时间窗: Baseline through week 35
Evaluated by Enzyme-Linked ImmunoSorbent Assay (ELISA) analysis
次要结局
- Change in Best Corrected Visual Acuity (BCVA)(Baseline through week 35)
- Change in Analytes - Interleukins(Baseline through week 52)
- Change in Intraocular Pressure (IOP)(Baseline through week 52)
- Change in Analytes - Chemokine (C-X-C Motif) Ligand (CXCL)s(Baseline through week 52)
- Number of Intravitreal Injections(Baseline through week 52)
- Change in Analytes - Chemokine (C-C Motif) Ligand (CCL)s(Baseline through week 52)
- Change in Analytes - Growth Factors(Baseline through week 52)
- Change in Analytes - Interferons(Baseline through week 52)
- Change in Analytes - Proteins(Baseline through week 52)