Wet Age-related Macular Degeneration (wAMD)
Conditions
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.
Interventions
None listed
Sponsors
Chengdu Kanghong Biotech Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events of Special Interest(AESI) | 1 year | 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 |
| SAE | 1 year | To observe the type, incidence and severity of all severe adverse events during the study |
| Other Ocular Adverse Events | 1 year | 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. |
| Adverse Events of Special Population | 1 year | 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. |
| 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. |
| Non-ocular Adverse Events | 1 year | To observe the type, incidence and severity of non-ocular adverse events during the study |
Countries
China
Contacts
Primary ContactNingli Wang
Outcome results
None listed