Ultra-wide Fluorescein angiograpHy to Evaluate the Progression of Retinal ischeMia After aflibErcept Injections in patientS With Central Retinal Vein Occlusion in Real Life (HERMES Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 9
- 主要终点
- Change from baseline in non-perfused areas in both macula and peripheral retina at 12 months
研究概览
简要总结
In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in United States and GALILEO study performed in Europe and Asia/Pacific.
With the project of Hermes Study, the first observational study conducted in France in patients with CRVO and treated with aflibercept, we would like to evaluate in real life the monitoring and the use of Aflibercept. The primary objective of this study will also be based on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal perfusion will be particularly evaluated by using ultra wide field angiography technology.
详细描述
The pathophysiology of Central Retinal Vein Occlusion (CRVO) is incompletely understood, but a significant slow-down in blood flow, caused by various predisposing factors, results in the release of VEGF, leading to the breakdown of the blood-retinal-barrier and finally to macular edema. The level of VEGF has been also correlated with neovascularization and vascular permeability in patients with ischemic CRVO. Several treatments have been used to treat patients with CRVO such as hemodilution, surgery, laser treatment and corticoids injection. However anti-vascular endothelial growth factor (anti-VEGF) agents administered by intravitreal injection, improve both visual and anatomic outcomes in patients with macular edema secondary to CRVO. Aflibercept is a fusion protein, use by intravitreal injection. In patients with macular edema secondary to CRVO, Aflibercept demonstrated efficacy and safety in 2 parallel trials, interventional phase III studies, COPERNICUS study performed in United States and GALILEO study performed in Europe and Asia/Pacific. In these studies, anatomic outcomes such as ischemic progression and retinal perfusion status were evaluated as secondary objectives; the primary objective of these studies was visual outcome.
With the project of Hermes Study, the first observational study conducted in France in patients with CRVO and treated with aflibercept, we would like to evaluate in real life the monitoring and the use of Aflibercept. The primary objective of this study will also be based on anatomic outcomes. The evolution of retinal ischemia and the degree of non-retinal perfusion will be particularly evaluated by using ultra wide field angiography technology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman aged 18 years or more
- •Patients with a diagnosis of CRVO (presence of retinal hemorrhages associated with vein dilation and tortuosity in the 4 quadrants)
- •The decision for treatment with Aflibercept (Eylea®) has been made for patients with a decrease in Best Corrected Visual Acuity (BCVA) and macular edema
- •Duration of CRVO not more than 4 months
- •Naïve patients. Patient with previous CRVO (more than 12 months before the inclusion date) which completely resolved (normalization of visual acuity and fundus examination) and who experienced a recurrence of CRVO are also considered naive
- •Patient who agrees to participate to the study and who has given his/her written, informed consent
排除标准
- •Patient with another retinal disease in the study eye: diabetic retinopathy, maculopathy of any cause (age-related macular degeneration, epimacular membrane, myopia, etc) responsible for decreased vision, advanced glaucoma, cataract severely affecting vision and/or requiring surgical treatment during the 24 months study period
- •Patient who does not meet the local indication criteria for aflibercept treatment. Contraindications listed in the SmPCs must be taken into account including:
- •Hypersensitivity to the active substance aflibercept or to any of the excipients listed in SmPC of the product
- •Active or suspected ocular or periocular infection
- •Active severe intraocular inflammation
- •CRVO complicated with neovascularization of the anterior segment
- •Patient who has previously undergone laser panretinal photocoagulation, grid-laser or photodynamic therapy, any anti-VEGF or corticoids intravitreal injections in the study eye
- •Patient already included in the study for the treatment of the fellow eye
- •Pregnant or breastfeeding woman
- •Lack of effective contraception for women of childbearing age
- •Patient taking part in an interventional study
- •Patients not covered by the French Health Insurance
结局指标
主要结局
Change from baseline in non-perfused areas in both macula and peripheral retina at 12 months
时间窗: Baseline and 12 months
次要结局
- Mean time between the last two injections(Up to 18 weeks)
- Change in visual acuity from baseline to months 3, 6, 12 and 24(Baseline and 3, 6, 12 and 24 months)
- Change from baseline in non-perfused areas in both macula and peripheral retina at 3, 6 and 12 months(Baseline and 3, 6 and 12 months)
- Mean number of visits by patient from baseline to end-of-study visit(From baseline to 24 months)
- Change from baseline in central retinal thickness at 3, 6, 12 and 24 months(Baseline and 3, 6, 12 and 24 months)
- Mean number of injections by patient from baseline to end-of-study visit(From baseline to 24 months)
- Change in vascular density in OCT-A from baseline to months 3, 6, 12, 24(Baseline and 3, 6, 12 and 24 months)
研究者
Agnes Glacet-Bernard
Ophtalmologist
Centre Hospitalier Intercommunal Creteil