The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.
This is an open-label, non-randomized, unmasked, study of IAI in patients with choroidal neovascularization secondary to polypoidal choroidal vasculopathy (PCV). Twenty treatment naïve and previously treated PCV eyes will be enrolled (only one study eye per patient will be enrolled). A maximum of 10 previously treated eyes will be enrolled. Consented, enrolled patients will be followed monthly. All patients will receive monthly IAI 2.0 mg intravitreally for 3 months (Baseline, Months 1 and 2), followed by mandatory IAI 2.0 mg every 2 months (Months 4, 6, 8 and 10) for 12 months. Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met. Starting at Month 3, patients can receive non-anti vascular endothelial growth factor (VEGF) rescue therapy (ie: Photodynamic Therapy (PDT), laser, intravitreal steroids) if the pre-defined criteria are met.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met.
Starting at Month 3, patients can receive non-anti VEGF rescue therapy (ie: PDT, laser, intravitreal steroids) if the pre-defined criteria are met.
Southeast Retina Center, PC
Augusta, Georgia, United States
RECRUITINGIncidence and Severity
The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 6.
Time frame: Month 6
Incidence and Severity
The primary objective of the study is the incidence and severity of ocular and systemic adverse events at Month 12.
Time frame: Month 12
Change in Best Corrected Visual Acuity (BCVA)
•The mean change in BCVA from Baseline to Month 6 and from Baseline up to 12 months
Time frame: Months 6 and 12
Change in Best Corrected Visual Acuity (BCVA)
•Proportion of patients gaining 5, 10 and 15 letters at Months 6 and 12
Time frame: Months 6 and 12
Change in Best Corrected Visual Acuity (BCVA)
•Proportion of patients losing 5,10, and 15 letters at Months 6 and 12
Time frame: Months 6 and 12
Photography Assessments
•Mean change from baseline in central subfield thickness at Months 6 and 12 as assessed on spectral domain optical coherence tomography (SD-OCT)
Time frame: Months 6 and 12
Photography Assessments
•Mean change from baseline in macular volume at Months 6 and 12 as assessed on SD-OCT
Time frame: Months 6 and 12
Photography Assessments
•Mean change from baseline in choroidal thickness at Months 6 and 12 through SD-OCT
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Time frame: Months 6 and 12
Photography Assessments
•Proportion of patients with no evidence of pigment epithelial detachment (PED), intraretinal and subretinal fluid from choroidal neovascularization (CNV) as assessed by optical coherence tomography (OCT) at 6 and 12 months
Time frame: Months 6 and 12
Photography Assessments
•Mean change from baseline in the total area of CNV fluorescein angiographic leakage at months 6 and 12
Time frame: Months 6 and 12
Photography Assessments
•Fluorescein angiograms, indocyanine green (ICG) angiograms, OCT and fundus photographs at Months 6 and 12 compared to baseline as unchanged, resolved, improved, worsened, or cannot determine. See section 9.1.2.2
Time frame: Months 6 and 12
Photography Assessments
•Rate of polyp regression and resolution at 6 and 12 Months
Time frame: Months 6 and 12