上海QL1207H注射液III期临床试验-QL1207H 注射液对比艾力雅®/Eylea®治疗新生血管性年龄相关性黄斑变性的Ⅲ期临床研究

登记号	CTR20261002	试验状态	进行中
申请人联系人	支旺旺	首次公示信息日期	2026-03-17
申请人名称	齐鲁制药有限公司

登记号	CTR20261002
相关登记号	暂无
药物名称	QL1207H注射液
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	新生血管性年龄相关性黄斑变性
试验专业题目	评价QL1207H 注射液对比艾力雅®/Eylea®（规格：114.3mg/mL（70μl 含有8mg 阿柏西普））治疗新生血管性年龄相关性黄斑变性有效性和安全性的多中心、随机、双盲、阳性对照、平行设计的Ⅲ期临床研究
试验通俗题目	QL1207H 注射液对比艾力雅®/Eylea®治疗新生血管性年龄相关性黄斑变性的Ⅲ期临床研究
试验方案编号	QL1207H-301	方案最新版本号	1.0
版本日期:	2025-11-03	方案是否为联合用药	否

申请人名称	[["齐鲁制药有限公司"]]
联系人姓名	支旺旺	联系人座机	0531-83126666	联系人手机号
联系人Email	wangwang.zhi@qilu-pharma.com	联系人邮政地址	山东省-济南市-历城区旅游路8888号	联系人邮编	250100

评价QL1207H注射液对比Eylea®在中国成人nAMD参与者中第12周BCVA变化的相似性

试验分类	有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国内试验

年龄	50岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["年龄≥50 周岁， 男女不限"],["研究眼继发于 nAMD 的活动性中心凹下型、 中心凹旁型 CNV 病变"],["研究眼筛选期， CNV 面积（包括经典型和隐匿型） ≥病灶总面积的 50%"],["研究眼筛选期，存在影响中心凹（定义为一个以中心凹为中心的直径为 1mm 的圆）n的 IRF 或 SRF"],["研究眼筛选期经 ETDRS 视力表评估， BCVA 为 24~78 个字母（包含边界值）"],["有生育能力的参与者自签署 ICF 至试验用药品末次给药后 4 个月内无捐精或捐卵n计划、无妊娠计划，且自愿采取有效避孕措施"]]
排除标准	[["研究眼筛选期存在非 nAMD 导致的 CNV 病变（如外伤、病理性近视、多灶性脉n络膜炎、眼组织胞浆菌病、血管样条纹等）"],["研究眼筛选期存在累及中心凹的瘢痕、纤维化、萎缩，或密集中心凹下硬性渗出"],["研究眼既往接受过法瑞西单抗、布西珠单抗、 114.3mg/ml 阿柏西普"],["研究眼筛选前 90 天内接受过其他抗 VEGF 药物治疗（如雷珠单抗、 40mg/ml 阿柏n西普、康柏西普、贝伐珠单抗等）"],["研究眼既往接受过眼内长效或缓释皮质类固醇药物治疗（如氟轻松玻璃体内植入n剂、地塞米松玻璃体内植入剂）"],["研究眼筛选前 90 天内行全视网膜激光光凝术、黄斑激光光凝术、光动力治疗、经n瞳孔温热疗法"],["对侧眼筛选期存在严重的视功能障碍， 包括但不限于 BCVA≤19 个字母数， 或者研n究者判断存在有其他预后较差的眼部疾病"],["任意眼既往接受过眼局部基因治疗或眼局部细胞治疗"],["任意眼筛选前 90 天内有眼内炎症/感染病史"],["已知对荧光素钠、聚维酮碘或试验用药品活性成分及其辅料过敏"],["筛选前 90 天内接受过全身抗 VEGF 治疗和全身类固醇激素治疗"],["妊娠期或哺乳期女性，或筛选期妊娠检查阳性"]]

试验药	[["中文通用名:QL1207H注射液 英文通用名:NA 商品名称:NA","剂型:注射剂 规格:114.3mg/ml 用法用量:玻璃体内注射，单次给药70μl 用药时程:治疗期前8周，每4周给药1次，连续给药3次。随后每16周给药1次、或根据给药频率调整标准进行给药，给药至第44周"]] 序号 名称 用法
对照药	[["中文通用名:阿柏西普眼内注射溶液 英文通用名:AfliberceptIntravitreousInjection 商品名称:艾力雅","剂型:注射剂 规格:114.3mg/mL 用法用量:玻璃体内注射，单次给药70μl 用药时程:治疗期前8周，每4周给药1次，连续给药3次。随后每16周给药1次、或根据给药频率调整标准进行给药，给药至第44周"]] 序号 名称 用法

主要终点指标及评价时间	[["研究眼第12周 ETDRS 视力表测量的 BCVA 字母数较基线的变化","第12周","有效性指标"]] 序号 指标 评价时间 终点指标选择
次要终点指标及评价时间	[["研究眼第 4、 8、 16、 20、 24、 28、 32、 36、 40、 44、48 周 ETDRS 视力表测量的 BCVA 字母数较基线的变化等","研究期间","有效性指标"],["不良事件的发生率及严重程度","研究期间","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	孙晓东	学位	医学博士	职称	教授
	电话	13386259752	Email	xdsun@sjtu.edu.cn	邮政地址	上海市-上海市-虹口区武进路85/86号
	邮编	200080	单位名称	上海市第一人民医院

[["上海市第一人民医院","孙晓东","中国","上海市","上海市"],["哈尔滨医科大学附属第一医院","张弘","中国","黑龙江省","哈尔滨市"],["安徽省立医院","董凯","中国","安徽省","合肥市"],["安徽医科大学第二附属医院","陶黎明","中国","安徽省","合肥市"],["保定市第一中心医院","张月玲","中国","河北省","保定市"],["北京爱尔英智眼科医院有限公司","谷威","中国","北京市","北京市"],["常州市第三人民医院","袁松涛","中国","江苏省","常州市"],["成都市第二人民医院","任辉","中国","四川省","成都市"],["成都中医药大学附属医院","郑燕林","中国","四川省","成都市"],["大连市第三人民医院","张立军","中国","辽宁省","大连市"],["复旦大学附属中山医院","袁源智","中国","上海市","上海市"],["惠州市中心医院","王丁丁","中国","广东省","惠州市"],["柳州市人民医院","万小波","中国","广西壮族自治区","柳州市"],["广西壮族自治区人民医院","崔凌","中国","广西壮族自治区","南宁市"],["广州爱尔眼科医院有限公司","俞晓艺","中国","广东省","广州市"],["贵州医科大学附属医院","王鲜","中国","贵州省","贵阳市"],["哈尔滨医科大学附属第二医院","孙大卫","中国","黑龙江省","哈尔滨市"],["河北省眼科医院","王莉菲","中国","河北省","邢台市"],["河南省立眼科医院","郭浩轶","中国","河南省","郑州市"],["湖州市中心医院","王媛媛","中国","浙江省","湖州市"],["淮安市第一人民医院","李超鹏","中国","江苏省","淮安市"],["吉林大学第二医院","肖骏","中国","吉林省","长春市"],["吉林大学第一医院","崔治华","中国","吉林省","长春市"],["济南市第二人民医院","张同河","中国","山东省","济南市"],["济宁市第一人民医院","冯洁","中国","山东省","济宁市"],["揭阳市人民医院","许钟毓","中国","广东省","揭阳市"],["九江市第一人民医院八里湖院区","欧阳君","中国","江西省","九江市"],["兰州大学第二医院","张文芳","中国","甘肃省","兰州市"],["洛阳市第三人民医院","李景波","中国","河南省","洛阳市"],["南昌大学第一附属医院","吴晓蓉","中国","江西省","南昌市"],["南昌大学附属眼科医院","游志鹏","中国","江西省","南昌市"],["南华大学附属第一医院","谭钢","中国","湖南省","衡阳市"],["南京市第一医院","李中国","中国","江苏省","南京市"],["内蒙古医科大学附属医院","朱丹","中国","内蒙古自治区","呼和浩特市"],["宁夏回族自治区人民医院","庄文娟","中国","宁夏回族自治区","银川市"],["濮阳市眼科医院","庞彦利","中国","河南省","濮阳市"],["山东第二医科大学附属医院","邓爱军","中国","山东省","潍坊市"],["山东第一医科大学附属青岛眼科医院","陈秀丽","中国","山东省","青岛市"],["山东第一医科大学附属眼科医院","原公强","中国","山东省","济南市"],["山西省眼科医院","周国宏","中国","山西省","太原市"],["汕头大学 · 香港中文大学联合汕头眼科医院","陈浩宇","中国","广东省","汕头市"],["深圳市人民医院","杨明明","中国","广东省","深圳市"],["石家庄市人民医院","任骞","中国","河北省","石家庄市"],["天津市眼科医院","韩梅","中国","天津市","天津市"],["天津医科大学眼科医院","李筱荣","中国","天津市","天津市"],["温州医科大学附属眼视光医院","刘晓玲","中国","浙江省","温州市"],["无锡市人民医院","姚勇","中国","江苏省","无锡市"],["梧州市工人医院","杨俊","中国","广西壮族自治区","梧州市"],["武汉爱尔眼科医院","吴建华","中国","湖北省","武汉市"],["西安市第一医院","陆慧琴","中国","陕西省","西安市"],["徐州医科大学附属医院","王雷","中国","江苏省","徐州市"],["云南大学附属医院","焦康为","中国","云南省","昆明市"],["长治市人民医院","王峰","中国","山西省","长治市"],["浙江大学医学院附属第一医院","董枫","中国","浙江省","杭州市"],["郑州市第二人民医院","陈梦平","中国","河南省","郑州市"],["中国人民解放军陆军特色医学中心","刘玮","中国","重庆市","重庆市"],["武汉市普仁医院","桂玉敏","中国","湖北省","武汉市"],["中山大学中山眼科中心","刘炳乾","中国","广东省","广州市"],["重庆医科大学附属第一医院","彭惠","中国","重庆市","重庆市"],["遵义市第一人民医院","谭薇","中国","贵州省","遵义市"],["抚顺市眼病医院","臧博","中国","辽宁省","抚顺市"],["贵州省人民医院","姬红培","中国","贵州省","贵阳市"],["河北医科大学第二医院","刘丹岩","中国","河北省","石家庄市"],["湖南省人民医院","杨劲松","中国","湖南省","长沙市"],["山西白求恩医院","段雅剑","中国","山西省","太原市"],["皖南医学院弋矶山医院","吴昌凡","中国","安徽省","芜湖市"],["武汉市中心医院","项奕","中国","湖北省","武汉市"],["西安交通大学第一附属医院","裴澄","中国","陕西省","西安市"],["西安市人民医院（西安市第四医院）","张妍春","中国","陕西省","西安市"],["咸阳市第一人民医院","王敏","中国","陕西省","咸阳市"],["宜昌市中心人民医院","张海江","中国","湖北省","宜昌市"],["浙江大学医学院附属第二医院","方肖云","中国","浙江省","杭州市"],["郑州人民医院","闫媛媛","中国","河南省","郑州市"],["中国人民解放军空军军医大学第一附属医院","李曼红","中国","陕西省","西安市"],["中国医科大学附属第四医院","张帆","中国","辽宁省","沈阳市"],["遵义医科大学附属医院","谢兵","中国","贵州省","遵义市"],["上海市同仁医院","邱庆华","中国","上海市","上海市"],["苏北人民医院","周芬","中国","江苏省","扬州市"],["赣南医科大学第一附属医院-章贡院区","蒋贻平","中国","江西省","赣州市"],["厦门大学附属厦门眼科中心医院","黎晓新","中国","福建省","厦门市"],["四川省人民医院","丁小燕","中国","四川省","成都市"],["深圳眼科医院","迟玮","中国","广东省","深圳市"],["北京大学深圳医院","张斌","中国","广东省","深圳市"],["中南大学湘雅二医院","罗静","中国","湖南省","长沙市"],["湖南医药学院总医院","于兰/史萍","中国","湖南省","怀化市"],["长沙爱尔眼科医院","陈忠平","中国","湖南省","长沙市"],["武汉大学人民医院","肖璇","中国","湖北省","武汉市"],["十堰市太和医院","张勇","中国","湖北省","十堰市"],["山东中医药大学附属眼科医院","温莹","中国","山东省","济南市"],["西安交通大学第二附属医院","柏凌","中国","陕西省","西安市"],["山西省人民医院","张丽","中国","山西省","太原市"],["宁波大学附属人民医院","陆勤康","中国","浙江省","宁波市"],["南阳医专一附院","王洪亮","中国","河南省","南阳市"],["安阳市眼科医院","穆泽辰","中国","河南省","安阳市"],["洛阳市中心医院","樊冬生","中国","河南省","洛阳市"],["河南医药大学第三附属医院","王爽","中国","河南省","新乡市"],["攀枝花市中西医结合医院","周莅斌","中国","四川省","攀枝花市"],["南方医科大学南方医院","张洪洋","中国","广东省","广州市"],["瑞安市人民医院","吴亮","中国","浙江省","温州市"],["赣州市人民医院","徐哲","中国","江西省","赣州市"],["北京医院","戴虹","中国","北京市","北京市"],["北京市海淀医院","窦宏亮","中国","北京市","北京市"],["齐齐哈尔市第一医院","路航","中国","黑龙江省","齐齐哈尔市"],["锦州市中心医院","何健","中国","辽宁省","锦州市"],["中国医科大学附属盛京医院","王爱媛","中国","辽宁省","沈阳市"],["东莞东华医院","杜绍林","中国","广东省","东莞市"],["江门市中心医院","彭超","中国","广东省","江门市"],["中山大学附属第三医院","凌士奇","中国","广东省","广州市"],["宁德师范学院附属宁德市医院","宫媛媛","中国","福建省","宁德市"],["桂林医学院附属医院","邱梅园","中国","广西壮族自治区","桂林市"],["喀什地区第一人民医院","蒋红文","中国","新疆维吾尔自治区","喀什地区"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["上海市第一人民医院人体试验伦理审查委员会","同意","2025-12-02"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 356 ；
已入组人数	国内: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；