Polypoidal choroidal vasculopathy (PCV) is a subtype of age-related macular degeneration (AMD). It is characterized by hemorrhage, serous exudates, and scar formation, all of which can lead to permanent vision loss. The incidence of exudative AMD is particularly high among the Asian population. In the West, only 4-9.8% of all exudative AMD cases are reported to be PCV, whereas in the East, 50% of exudative AMD cases are PCV cases. 
Limited studies have been conducted on the treatment regimen and natural progression of PCV compared with classic AMD. Studies on anti-vascular endothelial growth factor (VEGF) therapy have established it as a first-line therapy for AMD. However, whether the treatment should be used as a first-line therapy for treating PCV remains controversial. 
Since the release of aflibercept, however, many studies have reported that aflibercept monotherapy yielded favorable functional outcomes and a favorable polyp closure rate when used to treat PCV 
Therefore, through this study, it is intended to be helpful in establishing a protocol for treatment of PCV by confirming the results of aflibercept monotherapy with a fixed regimen in patients with PCV

Treatment

Each patient received aflibercept (2.0 mg) injections (fixed dosing) in an aseptic operation room. For the loading phase, each patient was administered with an aflibercept injection once a month for three months; subsequently, maintenance injections were administered every two months. For 12 months, seven injections were administered at baseline and at the one-, two-, four-, six-, eight-, and ten-month follow-up visits.
At every follow-up visit after the initial baseline visit, best-corrected visual acuity (BCVA) was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart; intraocular pressure measurement, slit lamp examination, fundus photography, and optical coherence tomography (Spectralis, Heidelberg Engineering, Heidelberg, Germany) were performed as well. At baseline and at four and 12 months, fluorescein and indocyanine green angiography (ICGA) (HRA system; Heidelberg Engineering, Heidelberg, Germany) were performed.

Arm Label

Target Number of Participant

Arm Type

Arm Description

Each patient received aflibercept (2.0 mg) injections (fixed dosing) in an aseptic operation room. For the loading phase, each patient was administered with an aflibercept injection once a month for three months; subsequently, maintenance injections were administered every two months. For 12 months, seven injections were administered at baseline and at the one-, two-, four-, six-, eight-, and ten-month follow-up visits.
At every follow-up visit after the initial baseline visit, best-corrected visual acuity (BCVA) was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart; intraocular pressure measurement, slit lamp examination, fundus photography, and optical coherence tomography (Spectralis, Heidelberg Engineering, Heidelberg, Germany) were performed as well. At baseline and at four and 12 months, fluorescein and indocyanine green angiography (ICGA) (HRA system; Heidelberg Engineering, Heidelberg, Germany) were performed.

Gender

Age

Description

Patients with confirmed Polypoidal Choroidal Vasculopathy by indocyanine green angiography
Optical coherence tomography shows subretina or intraretina fluid
Best corrected visual acuity between 20/200 and 20/20
Patients 3 months after the last intravitreal injection treatment

Patients with retinal diseases other than age-related macular degeneration 
Patients who have a history of intraocular surgery, excluding cataract surgery
Patients with a history of glaucoma
Patients with a history of eye inflammation, such as uveitis

Mean change in BCVA from baseline to 12 months

12 months visit

Proportion of patients who had complete intraretinal/subretinal fluid resolution after 12 months

12 months visit

Proportion of patients who had complete polypoidal lesion disappearance after 12 months

12 months visit

proportion of patients  with visual acuity of 20/40 or higher after 12 months,

12 months visit

Pproportion of patients with improved visual acuity of 15 letters or more after 12 months

12 months visit

Change in retinal thickness from bas,eline to 12 months

12 months visit

Change in average number of polyps from baseline to 12 months

12 months visit