Evidence map›Paper›PMID 31757691›Full record

Trial reportOphthalmology. Retina2020

Longitudinal Panretinal Leakage and Ischemic Indices in Retinal Vascular Disease after Aflibercept Therapy: The PERMEATE Study.

Natalia Figueiredo, Sunil K Srivastava, Rishi P Singh, Amy Babiuch, Sumit Sharma, Aleksandra Rachitskaya, Katherine Talcott, Jamie Reese, Ming Hu, Justis P Ehlers

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology. Retina, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02503540 (Peripheral and Macular Retinal Vascular Perfusion and Leakage Dynamics in Diabetic Macular Edema and Retinal Venous Occlusions During Intravitreal Aflibercept Injection), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
3.9field-weighted citation impact, top 7% 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.

NCT02503540 phase4completednot on this map

Peripheral and Macular Retinal Vascular Perfusion and Leakage Dynamics in Diabetic Macular Edema and Retinal Venous Occlusions During Intravitreal Aflibercept Injection (IAI) Treatment for Retinal Edema: PERMEATE Study

TypeinterventionalSponsorJustis EhlersRan2015 to 2018Enrolled31ConditionsRetinal Vein Occlusion, Diabetic Macular Edema, Branch Retinal Vein Occlusion, Central Retinal Vein OcclusionArmsAflibercept
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

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  16. Leakage index on ultra-widefield fluorescence angiography in different regions of retina and its correlation with cystoid macular edema in central retinal vein occlusion eyes.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2021
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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

10 authors at 1 institution in 1 country.

Natalia FigueiredoThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Sunil K SrivastavaThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Rishi P SinghVitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Amy BabiuchThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Sumit SharmaVitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Aleksandra RachitskayaVitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Katherine TalcottThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Jamie ReeseThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Ming HuThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio; Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Justis P EhlersThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio. Electronic address: ehlersj@ccf.org.
Cleveland Clinic · US

Funding

Intraoperative Optical Coherence Tomography for Ophthalmic SurgeryK23EY022947 · NEI · CLEVELAND CLINIC LERNER COM-CWRU · PI EHLERS, JUSTIS · 2013 to 2017
$1.0M
NEI NIH HHS K23 EY022947
6 · The paper itself

Abstract

purposeTo characterize the longitudinal panretinal retinal vascular dynamics in diabetic macular edema (DME) and retinal vein occlusion (RVO) over a 12-month period while being treated with intravitreal aflibercept injections (IAIs).

designProspective open-label study (clinicaltrials.gov identifier, NCT02503540).

participantsThirty-one treatment-naive eyes with foveal-involving retinal edema secondary to DME and RVO.

methodsParticipants received 2 mg IAI every 4 weeks for the first 6 months, followed by 2 mg every 8 weeks. Ultra-widefield fluorescein angiography (UWFA; California Optos [Optos, Dunfermline, United Kingdom]) and spectral-domain OCT (Cirrus; Zeiss, Oberkochen, Germany) scans were obtained and analyzed using a novel quantitative assessment platform. Visual acuity, central subfield thickness, and adverse events also were collected.

main outcome measuresThe primary end point was the mean change in panretinal leakage index at month 12 from baseline as measured by UWFA.

resultsMean age was 67.1 years. At month 12, visual acuity significantly improved by a mean of 18.4±21.4 letters (P < 0.0001), and central subfield thickness also improved significantly, with a mean reduction of 301.3±250.3 μm (P < 0.0001). Mean panretinal leakage index improved significantly, decreasing from 3.4% at baseline to 0.5% at month 6 (P <0.0001) and 0.4% at month 12 (P < 0.0001). Panretinal ischemic index did not demonstrate any significant change but showed a nonsignificant increase from 5.5% at baseline to 6.1% at month 6 (P = 0.315) and 8.7% at month 12 (P = 0.193). Eyes with DME showed a decrease in leakage index from 3.5±2.7% at baseline to 1.6±0.8% at month 12 (P = 0.018) and overall stability in ischemic index from 5.0±4.1% at baseline to 4.7±3.5% at month 12 (P = 0.689). Participants with RVO showed a decrease in leakage index from 3.3±1.1% at baseline to 0.02±0.03% at 12 months (P < 0.0001) and a nonsignificant increase in ischemic index from 5.9±4.5% at baseline to 12.6±9.8% at month 12 (P = 0.172).

conclusionsIntravitreal aflibercept injections resulted in a dramatic reduction in panretinal leakage index. Panretinal ischemic index did not improve and trended toward worsening.

Indexed as

Visual AcuityAgedAngiogenesis InhibitorsDiabetic RetinopathyFemaleFluorescein AngiographyFollow-Up StudiesFundus OculiHumansIntravitreal InjectionsMacula LuteaMacular EdemaMaleProspective StudiesReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor A

Identifiers

PMID31757691
PMCPMC7024601
OpenAlexW2973104155

What OpenQuestion holds

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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.