The study will evaluate the efficacy and safety of two different regimens of anti-VEGF Therapy (OCTA plus OCT guided 3+PRN vs. OCT guided 3+PRN) in Chinese patients with PCV. This study is to provide long-term safety data in the treatment of Chinese patients with PCV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
For the OCTA plus OCT guided 3+PRN regimen, we recorded patients' data after retreatment by 3 monthly intravitreal injections of anti-VEGF drug. Subsequent reinjections were given as needed according to the changes in patients' visual acuity, activity of PCV lesions shown by OCTA and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this group underwent an examination, including ETDRS visual acuity, fundus photography, OCTA and OCT. In case of BVN increased or polypoidal lesion progressed on OCTA scans, persistent subfoveal or perifoveal fluid, macular intraretinal edema on OCT scans, or visual loss of \>5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later.
For the OCT guided 3+PRN group, we recorded patients'data after retreatment by 3 monthly intravitreal injections of Anti-VEGF drugs. Subsequent reinjections were given as needed according to the changes in patients'visual acuity and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this group underwent an examination, including ETDRS visual acuity, fundus photography, and OCT. In case of persistent subfoveal or perifoveal fluid, macular intraretinal edema, visual loss of \>5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later.
Shanghai General Hospital, Shanghai Jiao Tong University
Shanghai, China
PCV lesion recurrence
PCV lesion recurrence is defined as the reappearance of new exudative biomakers (such as IRF, SRF, PED) or new hemorrhage detected on OCT or fundus examination in subsequent visits from the last visit showing clinical stability. PCV lesion recurrence rate will be compared at 24months between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.
Time frame: 24 months
Mean Snellen BCVA at every visit or treatment
Compare of mean Snellen Best-Corrected-visual-acuity at every visit or treatment between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.
Time frame: 24 months
Number of participants with treatment-related adverse events
Compare of Number of participants with treatment-related adverse events between the two groups to assess the safety of OCTA plus OCT guided 3+PRN regimen
Time frame: 24 months
Mean number of injections after the initial three loading dose monthly injections
Compare of mean number of injections after the initial three loading dose monthly injections between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.
Time frame: 21 months
Mean central macular thickness at every visit or treatment by OCT
Compare of mean central macular thickness by OCT at every visit or treatment between the two groups to assess the efficacy of OCTA plus OCT guided 3+PRN regimen.
Time frame: 24 months
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Conbercept or other anti-VEGF drugs