Safety Evaluation of China Patients: Long-term Treatment Outcome of Conbercept Ophthalmic Injection in Real Word（STONE）

• Conditions: Wet Age-related Macular Degeneration (wAMD)

• Registration Number: NCT03054818
• Lead Sponsor: Chengdu Kanghong Biotech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Status Verified: 2017-02
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-13
• Last Update Submitted: 2017-02-13
• Study First Posted: 2017-02-16
• Last Update Posted: 2017-02-16
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
New Adverse Reactions	1 year	To observe the type, incidence and severity of new adverse reactions in patients who have received intravitreal injection of Conbercept Ophthalmic Injection during the study;
Common Ocular Adverse Events	1 year	To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.

Secondary Outcome Measures

Name	Time	Method
Adverse Events of Special Interest(AESI)	1 year	To evaluate the AESI's correlation with Conbercept Ophthalmic Injection therapy.
SAE	1 year	To evaluate the SAEs' correlation with Conbercept Ophthalmic Injection therapy.
Non-ocular Adverse Events	1 year	To evaluate the Non-ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
Adverse Events Related to Intravitreal Injection Practices	1 year	To observe the incidence and severity of possible adverse events related to intravitreal injection practices of Conbercept Ophthalmic Injection during the study.
Adverse Events of Special Population	1 year	To evaluate the AEs' correlation with Conbercept Ophthalmic Injection therapy.
Other Ocular Adverse Events	1 year	To evaluate the Other Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.

Trial Locations

Locations (49)

Baoji People'S Hospital; 🇨🇳 Baoji, China

Beijing Aier-Intech Eye Hospital; 🇨🇳 Beijing, China

Beijing Tongren Hospital, Cmu; 🇨🇳 Beijing, China

Eye Hospital, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China

The 306Th Hospital of Pla; 🇨🇳 Beijing, China

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, China

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China

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