Evidence map›Paper›PMID 33640493›Full record

Trial reportOphthalmology. Retina2021

Longitudinal Assessment of Ellipsoid Zone Integrity, Subretinal Hyperreflective Material, and Subretinal Pigment Epithelium Disease in Neovascular Age-Related Macular Degeneration.

Justis P Ehlers, Robert Zahid, Peter K Kaiser, Jeffrey S Heier, David M Brown, Xiangyi Meng, Jamie Reese, Thuy K Le, Leina Lunasco, Ming Hu and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology. Retina, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
8.4field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 58 citations in OpenAlex.

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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

11 authors at 4 institutions in 1 country.

Justis P EhlersThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio; Center for Ocular Research and Evaluation, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: ehlersj@ccf.org.
Robert ZahidNovartis Pharmaceuticals, East Hanover, New Jersey.
Peter K KaiserCenter for Ocular Research and Evaluation, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Jeffrey S HeierOphthalmic Consultants of Boston, Boston, Massachusetts.
David M BrownRetina Consultants of Houston, Houston, Texas.
Xiangyi MengNovartis Pharmaceuticals, East Hanover, New Jersey.
Jamie ReeseCenter for Ocular Research and Evaluation, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Thuy K LeThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio; Center for Ocular Research and Evaluation, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Leina LunascoThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio; Center for Ocular Research and Evaluation, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Ming HuThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio; Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio.
Sunil K SrivastavaThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio; Center for Ocular Research and Evaluation, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Cleveland Clinic · USNovartis (United States) · USOphthalmic Consultants of Boston · USRetina Consultants of Texas · US

Funding

RESOURCE/SERVICE CORE C - MOLECULAR INFORMATICS MODULEP30EY025585 · NEI · CLEVELAND CLINIC LERNER COM-CWRU · PI BELA ANAND-APTE · 2016 to 2026
$7.7M
Intraoperative Optical Coherence Tomography for Ophthalmic SurgeryK23EY022947 · NEI · CLEVELAND CLINIC LERNER COM-CWRU · PI EHLERS, JUSTIS · 2013 to 2017
$1.0M
Preparation and Planning for the Prospective Randomized Image-guided Ophthalmic Surgery Clinical TrialsR34EY029308 · NEI · CLEVELAND CLINIC LERNER COM-CWRU · PI EHLERS, JUSTIS · 2018 to 2019
$480k
NEI NIH HHS K23 EY022947NEI NIH HHS P30 EY025585NEI NIH HHS R34 EY029308
6 · The paper itself

Abstract

purposeTo assess longitudinally the effect of anti-vascular endothelial growth factor (VEGF) treatment on ellipsoid zone (EZ) integrity, subretinal hyperreflective material (SHRM), and the sub-retinal pigment epithelium (sub-RPE) compartment in eyes with neovascular age-related macular degeneration (nAMD).

designPost hoc analysis of the OSPREY clinical trial, a prospective, double-masked, phase 2 study comparing brolucizumab 6 mg with aflibercept 2 mg over 56 weeks.

participantsParticipants with treatment-naïve nAMD at the initiation of the trial were included in the analysis.

methodsEyes were evaluated with spectral-domain OCT at 4-week intervals in the OSPREY trial (n = 81). Spectral-domain OCT scans collected from each visit were segmented automatically using a proprietary, machine learning-enabled higher-order feature-extraction platform for retinal layer, SHRM, and sub-RPE boundary lines, which were evaluated and corrected as needed by masked trained graders. The current analysis focused only on patients evaluated with the Cirrus (Zeiss) platform (n = 28).

main outcome measuresOutcome measures included change from baseline in EZ-RPE (i.e., photoreceptor outer segment) volume, EZ-RPE central subfield thickness (CST), total EZ attenuation, SHRM volume, SHRM CST, and total sub-RPE volume. The correlation between each of these measures and best-corrected visual acuity (BCVA) at each visit was evaluated.

resultsEZ-RPE volume and EZ-RPE CST showed significant increases, and total EZ attenuation, SHRM volume, SHRM CST, and total sub-RPE volume showed significant decreases from baseline at each visit from weeks 4 through 56 (P < 0.05 at each visit). Ellipsoid zone integrity measures and SHRM volume correlated significantly with BCVA at most visits (P < 0.05). No significant correlation was found between total sub-RPE volume and BCVA.

conclusionsEZ integrity, SHRM, and sub-RPE disease features in eyes with nAMD showed improvement as early as week 4 of anti-VEGF treatment. EZ integrity measures and SHRM volume were predictors of visual acuity over the first year of treatment.

Indexed as

Visual AcuityAgedAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedFemaleFluorescein AngiographyFollow-Up StudiesFundus OculiHumansMaleReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsRetinal Pigment EpitheliumTomography, Optical CoherenceWet Macular DegenerationafliberceptAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedbrolucizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsEllipsoid zoneneovascular age-related macular degenerationOCTsubretinal hyperreflective materialsub–retinal pigment epithelium

Identifiers

PMID33640493
PMCPMC8387490
OpenAlexW3135623921

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.