Evidence map›Paper›PMID 27465105›Full record

Trial reportBMC ophthalmology2016

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

Gregg T Kokame, James C Lai, Raymond Wee, Ryan Yanagihara, Jessica G Shantha, Julia Ayabe, Kelsi Hirai

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMC ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01871376 (Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01871376 phase4completednot on this map

Intravitreal Aflibercept Injection for Polypoidal Choroidal Vasculopathy With Hemorrhage or Exudation

TypeinterventionalSponsorGregg T. Kokame, MDRan2013 to 2016Enrolled25ConditionsPolypoidal Choroidal VasculopathyArmsIntravitreal aflibercept injection 2.0mg
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Clinical characteristics of super stable polypoidal choroidal vasculopathy after initial remission with anti-VEGF monotherapy.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2021
    Article
  10. Choroidal nevus and polypoidal vasculopathy: case series.International journal of retina and vitreous · 2020
    Article
  11. Article
  12. Article
  13. Polypoidal Choroidal Vasculopathy.Current ophthalmology reports · 2019
    Article
  14. Review
  15. Observational
  16. Polypoidal Choroidal Vasculopathy.Current ophthalmology reports · 2017
    Article
  17. Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Gregg T KokameDivision of Ophthalmology, Department of Surgery, University of Hawaii School of Medicine, 651 IIalo St, Honolulu, HI, 96813, USA. retinahi@aol.com.
James C LaiDivision of Ophthalmology, Department of Surgery, University of Hawaii School of Medicine, 651 IIalo St, Honolulu, HI, 96813, USA.
Raymond WeeThe Retina Center at Pali Momi, 98-1079 Moanalua Road, Suite 470, Aiea, Hawaii, 96701, USA.
Ryan YanagiharaThe Retina Center at Pali Momi, 98-1079 Moanalua Road, Suite 470, Aiea, Hawaii, 96701, USA.
Jessica G ShanthaThe Retina Center at Pali Momi, 98-1079 Moanalua Road, Suite 470, Aiea, Hawaii, 96701, USA.
Julia AyabeJohn A. Burns School of Medicine, University of Hawaii School of Medicine, 651 Ilalo St, Honolulu, HI, 96813, USA.
Kelsi HiraiJohn A. Burns School of Medicine, University of Hawaii School of Medicine, 651 Ilalo St, Honolulu, HI, 96813, USA.
Macula and Retina Institute · USRetina Institute of Hawaii · USUniversity of Hawaiʻi at Mānoa · USUniversity of Hawaii System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 4(th) 2013.

Indexed as

AgedAged, 80 and overAngiogenesis InhibitorsChoroidal NeovascularizationChoroid HemorrhageFemaleHumansIntravitreal InjectionsMaleMiddle AgedProspective StudiesReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsRetinal DetachmentRetinal Pigment EpitheliumVisual AcuityafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsAfliberceptChoroidal neovascularizationExudative macular degenerationPolypoidal choroidal vasculopathyRetinal pigment epithelial detachment

Identifiers

PMID27465105
PMCPMC4964097
OpenAlexW2505675135

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.