Prospective clinical trial of Intravitreal aflibercept treatment for PolypoIdal choroidal vasculopathy with hemorrhage or exudation (EPIC study): 6 month results

Abstract

BackgroundPolypoidal choroidal vasculopathy is a variant of choroidal neovascularization and neovascular age related macular degeneration presenting with hemorrhagic and exudative changes within the macula and/or peripapillary region leading to vision loss. In contrast to neovascular age related macular degeneration, polypoidal choroidal vasculopathy has differing clinical manifestations and treatment strategies. Historically, polypoidal choroidal vasculopathy complexes are less responsive to anti-vascular endothelial growth factor therapy with no prospective clinical trials evaluating aflibercept in management of polypoidal choroidal vasculopathy. Herein we prospectively evaluate the efficacy and safety of intravitreal aflibercept in polypoidal choroidal vasculopathy.MethodsA prospective, open-label, investigator-sponsored trial of intravitreal aflibercept for polypoidal choroidal vasculopathy in 21 eyes was conducted. Injections were administered monthly for 3 initial treatments, then every other month with monthly evaluations. The primary outcome measures were the mean change in best corrected visual acuity and adverse events. Secondary outcome measures included stabilization of vision, presence of subretinal hemorrhage, serous detachment, retinal pigment epithelial detachment, and regression of polypoidal complexes on indocyanine green angiography.ResultsAt 6 months, the median visual acuity was 20/40 (range 20/25–20/200) with a mean Early Treatment Diabetic Retinopathy Study vision of 68.4 letters. There was a gain of 2.76 Early Treatment Diabetic Retinopathy Study letters at 6 months (p = 0.15). No patient developed severe vision loss (≤15 letters) and vision was stable or improved in 19/21 eyes (91 %). Subretinal fluid resolved in 13/18 eyes (72 %), and subretinal hemorrhage resolved in 6/8 eyes (75 %) respectively. The polyps regressed in 14/21 eyes (67 %) and the branching vascular network decreased in 1 eye and was stable in all other eyes. The retinal pigment epithelial detachment improved in 13/15 eyes (87 %). Bimonthly treatment occurred in 15/21 patients (71 %). There were no adverse events.ConclusionsIntravitreal aflibercept results in stabilization of vision, resolution of exudative and hemorrhagic complications with regression of polyps in polypoidal choroidal vasculopathy. Eyes with polypoidal choroidal vasculopathy previously treated with ranibizumab and bevacizumab can show marked improvement in the retinal pigment epithelial detachments and persistent polyps with aflibercept therapy.Trial registrationClinical trials.gov NCT01871376, June 4th 2013Electronic supplementary materialThe online version of this article (doi:10.1186/s12886-016-0305-2) contains supplementary material, which is available to authorized users.

Comparing Ranibizumab and Aflibercept for Treatment of Polypoidal Choroidal Vasculopathy

“…For PCV treatment, intravitreal aflibercept injection shows comparable results to PDT in terms of regression of polyps with stabilization of vision [15,16]. Hosokawa et al [15] reported that, at six months after aflibercept injection, polyp lesions were completely resolved in 77.7% of patients.…”

“…Recent work investigating the effectiveness of aflibercept treatment in PCV has documented polyp regression rates following intravitreal administration as falling between 67% and 77.7% [15,16,21]. For this reason, aflibercept monotherapy may be considered a comparable treatment option to PDT in patients with PCV.…”

“…One explanation for this may be that the time point we selected for polyp evaluation was likely different than those chosen in other studies. In this study, ICGA was performed at baseline and after three consecutive injections [15,16]. In other work, regression of the polypoidal lesions was evaluated at the sixth month after at least four rounds of injection.…”

Polypoidal Choroidal Vasculopathy

“…(111) Retrospective studies comparing aflibercept and ranibizumab have demonstrated similar significant improvements in vision and decreased central foveal thickness for both treatments. (113,115,117,121) However, aflibercept treated eyes had more frequent polyp regression (34–75%) than ranibizumab treated eyes (22%). (113,115,117,121) Additionally, retrospective studies of ranibizumab “non-responders” who were switched to aflibercept treatment demonstrated reduced exudation, reduced choroidal thickness, and stable or improved vision.…”

Spectral-Domain Optical Coherence Tomography Angiography for the Diagnosis and Evaluation of Polypoidal Choroidal Vasculopathy

“…The detection of PCV is important; although eyes with PCV often have good visual outcomes with intravitreal anti-vascular endothelial growth factor (VEGF) injection monotherapy, eyes with PCV are more likely to be resistant to monotherapy than eyes with other subtypes of exudative AMD [6][7][8][9]. Once PCV is diagnosed, combination therapy with photodynamic therapy (PDT) and intravitreal anti-VEGF injections may have a higher chance of improving vision and promoting regression of polyps, DOI: 10.1159/000481540 edema, and subretinal fluid while decreasing the number of intravitreal injections needed and overall treatment burden for these patients [10,11].…”