An observational study in Wet Age-related Macular Degeneration (wAMD), sponsored by Chengdu Kanghong Biotech Co., Ltd.. Status unknown at 49 sites in China. Per ClinicalTrials.gov, last updated 2017-02-16.
Sponsored by Chengdu Kanghong Biotech Co., Ltd. · Observational
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 106 across 421 observational studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Chengdu Kanghong Biotech Co., Ltd. is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All medical academies will initially identify whether patients are enrolled based on baseline registration information.
Exclusion Criteria:
New Adverse Reactions
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;
Time frame: 1 year
Common Ocular Adverse Events
To observe the type, incidence and severity of common ocular adverse events in patients who have received intravitreal injection of Conbercept Ophthalmic Injection during the study, including: 1) bleeding at injection site; 2) increased intraocular pressure (IOP); 3) conjunctival congestion; 4) conjunctivitis; 5) decreased visual sensitivity; and 6) muscae volitantes.
Time frame: 1 year
Common Ocular Adverse Events
To evaluate the Common Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
Time frame: 1 year
Other Ocular Adverse Events
To observe the type, incidence and severity of other ocular adverse events in patients who have received intravitreal injection of Conbercept Ophthalmic Injection during the study.
Time frame: 1 year
Other Ocular Adverse Events
To evaluate the Other Ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
Time frame: 1 year
Non-ocular Adverse Events
To observe the type, incidence and severity of non-ocular adverse events during the study
Time frame: 1 year
Non-ocular Adverse Events
To evaluate the Non-ocular AEs' correlation with Conbercept Ophthalmic Injection therapy.
Time frame: 1 year
Adverse Events of Special Interest(AESI)
To observe the incidence and severity of adverse events of special interest (AESI) during the study, including: 1) retinal detachment; 2) retinal tears; 3) retinal pigment epithelial detachment; 4) retinal pigment epithelium tears; 5) geographic atrophy; 6) endophthalmitis; 7) arterial thromboembolic events (ATEs); and 8) hypertension
Time frame: 1 year
Adverse Events of Special Interest(AESI)
To evaluate the AESI's correlation with Conbercept Ophthalmic Injection therapy.
Time frame: 1 year
SAE
To observe the type, incidence and severity of all severe adverse events during the study
Time frame: 1 year
SAE
To evaluate the SAEs' correlation with Conbercept Ophthalmic Injection therapy.
Time frame: 1 year
Adverse Events Related to Intravitreal Injection Practices
To observe the incidence and severity of possible adverse events related to intravitreal injection practices of Conbercept Ophthalmic Injection during the study.
Time frame: 1 year
Adverse Events of Special Population
To observe the incidence and severity of adverse events of special population during the study,including children and adolescents (aged under 18), and pregnant women.
Time frame: 1 year
Adverse Events of Special Population
To evaluate the AEs' correlation with Conbercept Ophthalmic Injection therapy.
Time frame: 1 year
Plan to share: Undecided
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This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Chengdu Kanghong Biotech Co., Ltd.