Intravitreal Conbercept Injection in Patients With Myopic Choroidal Neovascularization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- BCVA change
研究概览
简要总结
Choroidal neovascularization (CNV) secondary to pathologic myopia (PM-CNV) is a common vision-threatening complication and often affects adults of working age. Intravitreal injection of any anti-vascular endothelial growth factor (VEGF) drugs would significantly suppress the activity of the CNV and finally improve the visual acuity. However, more than half of the patients would need one or more further injection for the recurrence or uncontrolled with 1+pro re nata (PRN) treatment within one year, and whether increasing the initial loading of intravitreal injection of anti-VEGF would be more efficacy for the controlling the PM-CNV remained unknown.
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 who are aged ≥18 years, male or female
- •Active choroidal neovascularization secondary to pathologic myopia
- •high myopia (defined as spherical equivalent ≤-6.0 diopter, AL≥26mm)
- •presence of posterior changes compatible with pathologic myopia
- •presence of active leakage from CNV, and presence of intra-retinal or subretinal fluid or increase of central retinal thickness
- •Presence of at least 1 of the following lesion types:
- •juxtafoveal with involvement of the central macular area
- •extrafoveal with involvement of the central macular area
- •margin of the optic disk with involvement of the central macular area
- •24≤BCVA≤78, at a starting distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) like VA chart ( 20/32-20/320 Snellen equivalent)
- •Visual loss only due to the presence of any eligible types of CNV related to pathologic myopia, based on clinical ocular findings, fluorescein angiography (FA), and optical coherence tomography (OCT) data.
- •Patients who are willing to participant in this study and sign the informed consent
排除标准
- •Pan-retinal or focal/grid laser photocoagulation with involvement of the macular area in the study eye at any time
- •Intraocular treatment with corticosteroids or intraocular surgery within 3 months prior to randomization and treatment with anti-VEGF or verteporfin photodynamic therapy at any time in the study eye.
- •Presence of CNV secondary to any cause other than pathologic myopia.
- •Presence of active infectious disease or intraocular inflammation, active or suspected periocular infection or iris neovascularization in either eye at the time of enrollment.
- •Pregnant or nursing women.
- •Patients with other coexisting ocular diseases, such as an abnormal cornea or a corneal infection, iridocorneal endothelial syndrome, anterior segment dysgenesis, nanophthalmos, chronic or recurrent uveitis, ocular cancer, trauma, central retinal vein occlusion, central retinal artery occlusion, and retinal detachment).
- •Patients with severe systemic disease and high risk when receiving intravitreous injection of anti-VEGF, such as diabetes mellitus, hypertension, end-stage cardiac disease, nephropathy, respiratory disease, cancer and HIV.
- •Patients had stroke, transient ischemic attack, myocardial infarction, acute congestive heart failure within 6 months prior to randomization
研究组 & 干预措施
Group A
patients were given intravitreal injection of Conbercept 0.5mg every month repeated for 3 months. Thereafter, intravitreal Conbercept 0.5mg injections should be administered in case CNV persisted or recurred (based on the assessment of defined criteria for retreatment) at a maximum frequency of once every 4 weeks through 12 months
干预措施: 3+PRN (Drug)
Group B
patients were given intravitreal injection of Conbercept 0.5mg every month repeated for 6 months.Thereafter, intravitreal Conbercept 0.5mg injections should be administered in case CNV persisted or recurred (based on the assessment of defined criteria for retreatment) at a maximum frequency of once every 4 weeks through 12 months
干预措施: 6+PRN (Drug)
结局指标
主要结局
BCVA change
时间窗: 12 months
the mean change in BCVA from the baseline to month 12 in patients with PM-CNV receiving Conbercept 0.5mg 3+PRN or 6+PRN
次要结局
- The treatment exposure(12 months)
- The change of CNV size(12 months)
- BCVA at 3 years(36 months)
- Recurrence rate of PM-CNV(12 months)