Clinical trial NCT03054818: Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word（STONE）
Official title: Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wet Age-related Macular Degeneration (wAMD)
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All medical academies will initially identify whether patients are enrolled based on baseline registration information.

Brief summary: This is a post-marketing drug safety monitoring study in a prospective manner, and data collection will be performed in a registration-follow-up manner. Safety information about patients who have received intravitreal injection of Conbercept Ophthalmic Injection in medical institutions involved in the study during research will be actively monitored without intervening in diagnosis and treatment. All patients enrolled will be followed up for one year.


Eligibility criteria: Inclusion Criteria:

1. The condition that informed consent has been freely given prior to research-related procedures;
2. Patients who have received at least one intravitreal injection of Conbercept Ophthalmic Injection after informed consent has been given.

Exclusion Criteria:

1. Patients who have been on any of other anti-VEGF drugs systematically or locally, including but not limited to bevacizumab, ranibizumab and aflibercept, 90 days before enrollment;
2. Those who are on other study drugs or have been on other study drugs 30 before informed consent is given.

Primary outcomes:
measure: New Adverse Reactions
timeFrame: 1 year
measure: Common Ocular Adverse Events
timeFrame: 1 year
measure: Common Ocular Adverse Events
timeFrame: 1 year
Secondary outcomes:
measure: Other Ocular Adverse Events
timeFrame: 1 year
measure: Other Ocular Adverse Events
timeFrame: 1 year
measure: Non-ocular Adverse Events
timeFrame: 1 year
measure: Non-ocular Adverse Events
timeFrame: 1 year
measure: Adverse Events of Special Interest(AESI)
timeFrame: 1 year
measure: Adverse Events of Special Interest(AESI)
timeFrame: 1 year
measure: SAE
timeFrame: 1 year
measure: SAE
timeFrame: 1 year
measure: Adverse Events Related to Intravitreal Injection Practices
timeFrame: 1 year
measure: Adverse Events of Special Population
timeFrame: 1 year
measure: Adverse Events of Special Population
timeFrame: 1 year
Other outcomes:
Locations:
city: Baoji
country: China
facility: Baoji People'S Hospital
city: Beijing
country: China
facility: Beijing Aier-Intech Eye Hospital
city: Beijing
country: China
facility: Beijing Tongren Hospital, Cmu
city: Beijing
country: China
facility: Eye Hospital, China Academy of Chinese Medical Sciences
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: The 306Th Hospital of Pla
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Dalian
country: China
facility: The third people's Hospital of Dalian
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of ZhejiangUniversity School of Medicine
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Hongkong
country: China
facility: JOINT SHANTOU INTERNATIONAL EYE CENTER of Shantou University and The Chinese University of Hong Kong
city: Jilan
country: China
facility: Shandong Eye Hospital
city: Jilan
country: China
facility: Shandong Provincal Hospital
city: Jiling
country: China
facility: The Second Hospital of Jilin University
city: Kashi
country: China
facility: Kashgar First People's Hospital
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
city: Mudanjiang
country: China
facility: Central Hospital of Mudanjiang Forestry
city: Nanjing
country: China
facility: Jiangsu Province Hospital of CTM
city: Nanning
country: China
facility: The People'S Hospital of Guangxi Zhuang Autonomous Region
city: Ningbo
country: China
facility: Ningbo Eye Hospital
city: Ningxia
country: China
facility: Ningxia People'S Hospital
city: Pingdingshan
country: China
facility: Pingdingshan People'S Hospital No.1
city: Qiqihar
country: China
facility: The First Hospital of Qiqihar
city: Shanghai
country: China
facility: Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Baoshan Hospital of Integrate Traditional Chinese and Western Medicine
city: Shanghai
country: China
facility: Shanghai General Hospital
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
city: Shenyang
country: China
facility: Shenyang the Fourth Hospital of People
city: Shenyang
country: China
facility: The Fourth Affiliated Hospital of China Medical University
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Shenzhen
country: China
facility: Shenzhen Eye Hospital
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: Shanxi Eye Hospital
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
city: Wuhan
country: China
facility: Wuhan General Hospital of Pla
city: Wulumuqi
country: China
facility: No.474 Hospital of Pla
city: Wuxi
country: China
facility: Wuxi NO.2 People's Hospital
city: Xi'an
country: China
facility: Tangdu Hospital
city: Xi'an
country: China
facility: Xi'An No.4 Hospitla
city: Xian
country: China
facility: Xijing Hospital
city: Xingtai
country: China
facility: Hebeisheng Eye Hospital
city: Xuzhou
country: China
facility: The First People's Hospital of Xuzhou
city: Zhongshan
country: China
facility: Zhongshan Ophthalmic Center, Sun Yay-Sen University
Study officials:
affiliation: BEIJING TONGREN HOSPITAL, CMU
name: Ningli Wang
role: PRINCIPAL_INVESTIGATOR
References: