To explore efficacy and safety of 0.5 mg conbercept ophthalmic injection for long-term treatment of polypoid choroidal vasculopathy (PCV) subjects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The target eye receives intravitreal injection of 0.5mg conbercept ophthalmic injection once every 12 weeks; if a subject meets "additional drug administration criteria" within 12 weeks between treatments, the subject can receive additional injection treatment
In principle, the first administration time of the target eye uses the time determined by the assessment at end of STAR study; later, based on "treatment-extension drug administration criteria", an investigator determines next visit time/treatment interval according to assessment result at each visit.When a subject's visit/treatment interval extends to 12 weeks, an additional safety visit can be arranged if an investigator considers that there is suspicious active lesion; if assessment result at the safety visit meets "additional drug administration criteria", additional injection treatment can be given.
change of best corrected visual acuity (BCVA)
Assess mean of change of best corrected visual acuity (BCVA) compared with baseline in the target eyes (using the same target eyes as STAR study) of subjects at end of the extension study;
Time frame: up to 40 week
adverse events
Assess incidence and severity of adverse events in subjects.
Time frame: up to 40 week
mean of change of BCVA
Assess mean of change of BCVA compared with that in STAR study baseline (before treatment) in the target eyes of subjects at end of the extension study
Time frame: up to 40 week
change of central retinal thickness (CRT)
Assess mean of change of central retinal thickness (CRT) compared with baseline in the target eyes of subjects at time of each visit till end of the extension study;
Time frame: up to 40 week
mean of change of lesion's maximum retinal thickness (MRT)
Assess mean of change of lesion's maximum retinal thickness (MRT), retinal pigment epithelium detachment's (PED) volume and thickness, polypoid lesion area, retinal hemorrhage area and other imaging indicators compared with baseline in the target eyes of subjects at end of the extension study;
Time frame: up to 40 week
average number of times of drug administration
Assess average number of times of drug administration in two groups of subjects during the extension treatment;
Time frame: up to 40 week
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