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Intravitreal aflibercept for active polypoidal choroidal vasculopathy without active polyps.

ABSTRACT: The purpose of this study was to evaluate the efficacy of intravitreal aflibercept for active polypoidal choroidal vasculopathy (PCV) without active polyps and to identify prognostic factors. We enrolled 40 eyes from 40 patients who manifested PCV with exudation but without active polyps after prior treatment with photodynamic therapy (PDT) and/or anti-vascular endothelial growth factor (VEGF) other than aflibercept. Participants were initially given three consecutive intravitreal injections of aflibercept at 1-month intervals, followed by injections every 2 months in the maintenance phase. Spectral-domain optical coherence tomographic and indocyanine green angiographic features were assessed to determine associations between anatomical parameters and visual outcomes 14?months later. Mean visual acuity improved from 61.5?±?11.1 letters at baseline to 68.1?±?13.6 letters at 14 months (P?=?0.001). Better vision and a smaller branching vascular network at baseline and 1 month after three monthly injections (visit 4) were associated with better final vision (P?

SUBMITTER: Lee SE

PROVIDER: S-EPMC6365522 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Intravitreal aflibercept for active polypoidal choroidal vasculopathy without active polyps.

Lee Sang Eun SE Jang Jun Won JW Kang Se Woong SW Park Kyu Hyung KH Lee Dong Won DW Kim Jae Hui JH Bae KunHo K

Scientific reports 20190206 1

The purpose of this study was to evaluate the efficacy of intravitreal aflibercept for active polypoidal choroidal vasculopathy (PCV) without active polyps and to identify prognostic factors. We enrolled 40 eyes from 40 patients who manifested PCV with exudation but without active polyps after prior treatment with photodynamic therapy (PDT) and/or anti-vascular endothelial growth factor (VEGF) other than aflibercept. Participants were initially given three consecutive intravitreal injections of ...[more]

PMID: 30728380

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Project description:Importance:Polypoidal choroidal vasculopathy (PCV) is common in Asian populations, but an optimal treatment approach remains to be confirmed. Objective:To evaluate intravitreal aflibercept injection (IAI) in participants with PCV and compare IAI monotherapy with IAI plus rescue photodynamic therapy (PDT). Design, Setting, and Participants:This 96-week, double-masked, sham-controlled phase 3b/4 randomized clinical trial was conducted at multiple centers in Australia, Germany, Hong Kong, Hungary, Japan, Singapore, South Korea, and Taiwan from May 2014 to August 2016, and included adults 50 years or older with symptomatic macular PCV and a best-corrected visual acuity of 73 to 24 Early Treatment Diabetic Retinopathy Study letters (20/40-20/320 Snellen equivalent). Interventions:Participants received 2 mg of IAI at weeks 0, 4, and 8. At week 12, participants with a suboptimal response were randomized 1:1 to receive IAI plus sham PDT (IAI monotherapy) or a "rescue" of IAI plus rescue PDT (IAI/PDT). Participants who did not qualify for rescue received IAI every 8 weeks; those qualifying for rescue received IAI every 4 weeks plus sham/active PDT. When the rescue criteria were no longer met, injection intervals were gradually extended to 8 weeks. Main Outcomes and Measures:Noninferiority of IAI monotherapy to IAI/PDT for mean change in best-corrected visual acuity from baseline to week 52 (95% CI of the difference entirely above -5 letters). Results:Of the 318 participants, the mean (SD) age was 70.6 (8.2) years, 96 (30.2%) were women, and 152 (47.8%) were Japanese. Monotherapy with IAI was noninferior to IAI/PDT for the primary end point (+10.7 vs +10.8 letters, respectively; 95% CI, -2.9 to 1.6; P = .55), with few participants requiring rescue therapy (19 [12.1%] vs 23 [14.3%], respectively). Participants in both treatment groups had similar reductions in central subfield thickness from baseline to week 52 (-137.7 [IAI monotherapy] vs -143.5 μm [IAI/PDT]). At week 52, 49 (38.9%) and 60 participants (44.8%) had no polypoidal lesions observed on indocyanine green angiography in the IAI monotherapy and IAI/PDT groups, respectively. Furthermore, 116 (81.7%) and 136 (88.9%), respectively, had no polypoidal lesions with leakage. The most frequent ocular adverse events were conjunctival hemorrhage (IAI monotherapy, 8 [5.1%]) and dry eye (IAI/PDT, 9 [5.6%]). Conclusions and Relevance:Improvement in visual and/or functional outcomes was achieved in more than 85% of participants who were treated with IAI monotherapy, with no signs of leakage from polypoidal lesions in more than 80%. As fewer than 15% met the criteria of a suboptimal response to receive PDT, the potential benefit of adding PDT cannot be determined. Trial Registration:ClinicalTrials.gov Identifier: NCT02120950.

Project description: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 4(th) 2013.

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Intravitreal aflibercept for active polypoidal choroidal vasculopathy without active polyps.

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Intravitreal aflibercept for active polypoidal choroidal vasculopathy without active polyps.

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