Navigated Laser In Branch Retinal Vein Occlusion Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Patients with additional need for anti-VEGF after loading phase
研究概览
简要总结
Branch retinal vein occlusion (BRVO) is often complicated by macular edema, possibly leading to severe visual loss or blindness. Treatment is repeated, intravitreal injections of vascular endothelial growth factor (VEGF)-inhibitors like aflibercept. The treatment is effective, but a need for repetitive injections is a concern for patients as well as society due to risk of side effects, regular hospital visits and the price of the drug. Former treatment included macular grid pattern photocoagulation, but this technology was limited by a poorer visual outcome for the patient and a higher risk of side effects, including central visual loss.
A novel laser delivery system, called navigated laser photocoagulation, has proven effective, safe and precise, and has shown promising results in stabilising the effect of the VEGF-inhibitor treatment in similar diseases.
Thus, in a 12-month prospective, randomized 1:1 study of 60 patients with BRVO and macular edema the investigators aim to (1) Examine the treatment response of patients treated with intravitreal aflibercept (Eylea®) and navigated retinal laser (Navilas®)(Group 1) as compared to patients treated with intravitreal aflibercept only (Group 2), and (2) Identify non-invasive retinal biomarkers (retinal oxygen saturation, macular ischemia and retinal vascular arteriolar and venular calibre) for successful treatment outcome.
详细描述
Purpose of the study
In a 12-month prospective, randomized 1:1 study of patients with branch retinal vein occlusion (BRVO) and macular edema, the investigators aim to
- Examine the treatment response of patients treated with intravitreal aflibercept (Eylea®) and navigated retinal laser (Navilas®)(Group 1) as compared to patients treated with intravitreal aflibercept only (Group 2), and
- Identify non-invasive retinal biomarkers (retinal oxygen saturation, macular ischemia and retinal vascular arteriolar and venular calibre) for successful treatment outcome.
Problem statement
Severe visual loss or blindness in BRVO is often caused by macular edema. Until a few years ago, treatment included observation or macular grid pattern laser photocoagulation. With this treatment it was often possible to stabilize the disease in a few treatment sessions. However, in recent years better visual outcome has been demonstrated with intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors like ranibizumab or aflibercept. Even though this is encouraging, patients on average need nine injections in the first 12 months. The high number of repetitive treatments is a concern for patients as well as society due to the invasiveness of the treatment and the price of the drug. Hence, it is warranted to develop newer treatment regimens combining the efficacy of intravitreal anti-VEGF with the potential stabilizing effect of macular laser photocoagulation. This would be an approach that might minimize the number of injections and its side effects while still providing acceptable visual outcomes for the patients.
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
- •Patients with BRVO with foveal center-involved macular edema in the study eye.
- •Best-corrected visual acuity (BCVA) 35-80 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (0.1-0.8 Snellen equivalent) in the study eye at baseline (BL).
- •Age ≥18 years.
- •Central retinal thickness > 300 μm in the study eye at BL.
- •Onset ≤ 6 months prior to the study.
排除标准
- •Active retinal or iris neovascularizations in the study eye at any time.
- •Cataract, vitreous hemorrhage or other clouding conditions that prevent retinal laser photocoagulation in the study eye at M
- •Prior anti-VEGF treatment or macular laser photocoagulation in the study eye.
- •Macular edema and/or increased retinal thickness due to other potential causes than BRVO
- •Uncontrolled hypertension (blood pressure ≥ 160/110 mmHg).
研究组 & 干预措施
Aflibercept + Navigated laser
Patients will receive intravitreal aflibercept at M0, M1 and M2 (loading phase) and in addition receive navigated retinal laser photocoagulation at M3. Patients will receive aflibercept according to pro re nata regimen from M3-M12.
干预措施: Aflibercept Injection [Eylea] (Drug)
Aflibercept + Navigated laser
Patients will receive intravitreal aflibercept at M0, M1 and M2 (loading phase) and in addition receive navigated retinal laser photocoagulation at M3. Patients will receive aflibercept according to pro re nata regimen from M3-M12.
干预措施: Navigated laser photocoagulation (Procedure)
Aflibercept only
Patients will receive intravitreal aflibercept at M0, M1 and M2 (loading phase). Patients will receive aflibercept according to pro re nata regimen from M3-M12.
干预措施: Aflibercept Injection [Eylea] (Drug)
结局指标
主要结局
Patients with additional need for anti-VEGF after loading phase
时间窗: Month 3 to Month 12
Percentage of patients in Groups 1 and 2 that receive additional intravitreal aflibercept after the loading phase
次要结局
- Retinal oxygen saturation(Baseline)
- Additional need for anti-VEGF after loading phase(Month 3 to Month 12)
- Change in BCVA according to treatment regimen(Month 12)
- Vessel geometry(Baseline)
- Visual field(Baseline and Month 12)
- Effect on macular edema according til treatment regimen(Month 12)
- Macular ischemia (area of FAZ)(Baseline)
研究者
Katrine Hartmund Frederiksen
Principal Investigator
Odense University Hospital