The Safety and Efficacy of Conbercept in the Treatment of Choroidal Neovascularization (CNV) Secondary to High Myopia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 176
- 试验地点
- 13
- 主要终点
- mean change from baseline of visual acuity
研究概览
简要总结
This study is design to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes compared to sham injection and durability of response observed in subjects with choroid neovascularization secondary to pathological myopia.
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
- Double (Participant, Investigator)
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 give fully informed consent and are willing and able to comply with all study procedures.
- •In the study eye:
- •Myopia of equal to or greater than -6.00D,and axial length ≥26.5mm.
- •Diagnosis of active subfoveal, juxafoveal, or extrafoveal CNV secondary to high myopia.
- •Visual impairment due to CNV secondary to high myopia.
- •BCVA score ≥24 and ≤73 ETDRS letters (approximately 20/40~ 20/320 Snellen equivalent).
- •Ocular media of sufficient quality to obtain fundus and OCT images.
- •The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent)
排除标准
- •Current vitreous hemorrhage in either eye.
- •Intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye.
- •Active infectious ocular inflammation in either eye.
- •Fibrosis or atrophy involving the center of foveal in the study eye.
- •Any concurrent intraocular condition in the study eye that, in the opinion of investigator, could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition.
- •The lesion size ≥30 mm2 in the study eye.
- •Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results.
- •Uncontrolled glaucoma or cup/disk ratio > 0.8 in the study eye.
- •Aphakia (excluding artificial lens) in the study eye.
- •Serious amblyopia and amaurosis in the fellow eye.
研究组 & 干预措施
conbercept treatment group
Subjects will receive conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 6 months, the investigator will decide whether repeat injections are needed base on the monthly assessment results.
干预措施: conbercept, Fixed (Drug)
conbercept treatment group
Subjects will receive conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 6 months, the investigator will decide whether repeat injections are needed base on the monthly assessment results.
干预措施: conbercept, PRN (Drug)
sham injection group
Subjects will receive sham injections monthly for 3 months and will receive 0.5 mg/eye conbercept at month 4. The investigator will decide whether repeat injections are needed base on the monthly assessment results from month 5 to month 9.
干预措施: conbercept, Fixed (Drug)
sham injection group
Subjects will receive sham injections monthly for 3 months and will receive 0.5 mg/eye conbercept at month 4. The investigator will decide whether repeat injections are needed base on the monthly assessment results from month 5 to month 9.
干预措施: conbercept, PRN (Drug)
sham injection group
Subjects will receive sham injections monthly for 3 months and will receive 0.5 mg/eye conbercept at month 4. The investigator will decide whether repeat injections are needed base on the monthly assessment results from month 5 to month 9.
干预措施: sham injection (Other)
结局指标
主要结局
mean change from baseline of visual acuity
时间窗: 3-month
to compare the mean change from baseline of best-corrected visual acuity (BCVA) between conbercept treatment group and sham injection group at month 3
次要结局
- mean change from baseline of anatomical features(3-month)
- mean change from baseline of visual acuity(9 months)
- safety and tolerability of conbercept(3-month and 9-month)