我国眼用制剂临床试验研究现状

目的：探讨国内眼用制剂临床试验研究现状和发展趋势，为我国眼用制剂的研发提供参考。方法：检索收集药物临床试验登记与信息公示平台登记的所有眼用制剂项目信息，采用文献计量学方法，统计临床试验项目登记的剂型与数量、申办者、研究分期、适应证、创新药研发现状、临床试验药物上市情况、国际多中心临床试验等信息，分析国内眼用制剂临床试验的特点。结果：（1）平台共登记了73项临床试验；（2）药物剂型以注射剂及滴眼剂为主；（3）适应证以黄斑水肿、黄斑变性等眼底病变为主；（4）创新药物共有12种（2种为化学药物创新药、10种为生物制品创新药），8种生物制品通过抗VEGF治疗眼底病变；（5）承担项目数量前3位的申办者中，2个为国内企业，1个为外资企业；（6）除创新药物外，其余24种临床试验相关药物中，有7种药物已完成试验并于国内上市；（7）国际多中心试验共14项，其中由国内企业申办的仅2项。结论：我国眼用制剂的项目数量逐年稳步增长，其中治疗眼底疾病的生物制品为研发热点；国内企业申报项目数量较多，但国内企业发起的国际多中心试验仍需提升。

The present situation of clinical trials of ophthalmic preparations in China

OBJECTIVE To explore the current status and development trend of clinical trials of ophthalmic preparations in China so as to provide references for domestic research and development of ophthalmic preparations.METHODS The relevant information of all ophthalmic preparations registered on the platform of drug clinical trial registration and information publicity was retrieved.By using bibliometrics, dosage form, quantity, sponsor, research stage, indications, research & development status of innovative drugs, marketing of clinical trial drugs, international multi-center clinical trials, etc.of registered clinical trials were counted and the characteristics of clinical trials for domestic ophthalmic preparations were analyzed.RESULTS A total of 73 clinical trials have been registered on the platform;The major dosage forms were injections and eye drops;The major indications were macular edema and macular degeneration;Ten kinds of innovative drugs(2 chemical innovative drugs & 8 biological innovative drugs) and 7 kinds of biological products for treating fundus diseases by anti-VEGF;Among Top Three sponsors for the number of projects, 2 were in Top Three;Besides innovative drugs, 7 of the other 24 clinical trial related drugs completed the trial and were listed in China;Among 14 international multi center trials, only 2 were applied by domestic enterprises.CONCLUSION The number of projects of ophthalmic preparations in China is increasing steadily yearly and research and development of biological products for treating fundus diseases has been a hot spot.Despite many ongoing projects of domestic enterprises, international multi-center trials initiated by domestic enterprises should be further strengthened.