The purpose of this study is to evaluate the efficacy and safety of the aflibercept 8 mg used in a personalized regimen, with flexible loading dose and treatment intervals from 8 to 24 weeks in eyes with treatment-naive PCV.
Signed informed consent must be obtained prior to participation in the study.
Male or female patients ≥ 19 years of age at screening
Presence of active polypoidal lesions in the macular as shown by ICGA and presence of serosanguinous maculopathy (exudative or hemorrhagic features involving the macula on floor fundus photography, FA and SD-OCT AND presence of IRF or SRF that affects the central subfield as seen by SD-OCT
Best-corrected visual acuity (BCVA) score between 83 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye)
Ocular conditions/disorders at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye)
A history of any evidence of type 2 or type 3 neovascularization, myopic choroidal neovascularization, or other ocular disorders
Total area of subretinal hemorrhage larger than 9DA or comprising ≥ 50% of the lesion area or presence of vitreous hemorrhage in study eye
Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)
Single group
aflibercept 8 mg
DrugThe first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively.
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96
Last injection interval at week 96
Best corrected visual acuity (BCVA) at weet 96
Measurement with the Early Treatment Diabetic Retinopathy Study (ETDRS) letters score
Central retinal thickness and choroidal thickness at week 96
Average retinal thickness at the central 1 mm diameter
umber of participants with treatment-related adverse events
Slit lamp examination and fundoscopy
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Yeungnam University College of Medicine
Lead sponsor
Bayer
Collaborator
