Evidence map›Paper›PMID 35569763›Full record

Trial reportOphthalmology. Retina2022

Impact of Baseline Quantitative OCT Features on Response to Risuteganib for the Treatment of Dry Age-Related Macular Degeneration: The Importance of Outer Retinal Integrity.

Joseph R Abraham, Glenn J Jaffe, Peter K Kaiser, Stephanie J Chiu, Jessica Loo, Sina Farsiu, Laurens Bouckaert, Vicken Karageozian, Melvin Sarayba, Sunil K Srivastava and 1 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Ophthalmology. Retina, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.0field-weighted citation impact, top 14% 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

10 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Age-Related Macular Degeneration, a Mathematically Tractable Disease.Investigative ophthalmology & visual science · 2024
    Review
  8. Article
  9. Automated Identification and Segmentation ofDiagnostics (Basel, Switzerland) · 2023
    Article
  10. Article
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 3 institutions in 1 country.

Joseph R AbrahamThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Glenn J JaffeDepartment of Ophthalmology, Duke University, Durham, North Carolina.
Peter K KaiserCole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Stephanie J ChiuDepartment of Ophthalmology, Duke University, Durham, North Carolina; Department of Biomedical Engineering, Duke University, Durham, North Carolina.
Jessica LooDepartment of Biomedical Engineering, Duke University, Durham, North Carolina.
Sina FarsiuDepartment of Ophthalmology, Duke University, Durham, North Carolina; Department of Biomedical Engineering, Duke University, Durham, North Carolina.
Laurens BouckaertAllegro Ophthalmics, San Juan Capistrano, California.
Vicken KarageozianAllegro Ophthalmics, San Juan Capistrano, California.
Melvin SaraybaAllegro Ophthalmics, San Juan Capistrano, California.
Sunil K SrivastavaThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Justis P EhlersThe Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cleveland Clinic, Cleveland, Ohio; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: ehlersj@ccf.org.
Cleveland Clinic · USDuke University · USAllegro Ophthalmics (United States) · 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
NEI NIH HHS K23 EY022947NEI NIH HHS P30 EY025585
6 · The paper itself

Abstract

objectiveThe purpose of the study was to perform a post hoc analysis to explore the effect of baseline anatomic characteristics identified on OCT on best-corrected visual acuity (BCVA) responses to risuteganib from the completed phase II study in subjects with dry age-related macular degeneration (AMD).

designPost hoc analysis of a randomized, double-masked, placebo-controlled, phase II study. SUBJECTS: Eyes with intermediate dry AMD with BCVA between 20/40 and 20/200. Patients with concurrent vision-influencing or macula-obscuring ocular pathologies were excluded.

methodsPatients were randomized to receive a 1-mg intravitreal risuteganib injection or a sham injection at baseline. A second 1-mg intravitreal injection of risuteganib was given at week 16 to those in the treatment arm. Two independent, masked reading centers evaluated the baseline anatomic characteristics on OCT to explore features associated with positive responses to risuteganib.

main outcome measuresTreatment response was defined as a gain of ≥ 8 letters in BCVA from baseline to week 28 in the treatment arm, compared with baseline to week 12 in the sham group. Anatomic parameters, measured by retinal segmentation platforms, including measures of retinal thickness were compared between the responders and nonresponders to risuteganib.

resultsThirty-nine patients completed the study and underwent analysis. In the treatment arm, 48% of eyes demonstrated treatment responses, compared with 7% in the sham group. In the quantitative anatomic assessment, enhanced ellipsoid integrity, greater outer retinal thickness, and decreased geographic atrophy were associated with increased BCVA gains to risuteganib.

conclusionsThis post hoc analysis demonstrated that baseline OCT features may help determine the likelihood of a functional response to risuteganib. The characterization of higher-order OCT features may provide important information regarding biomarkers for treatment response and could facilitate optimized clinical trial enrollment and enrichment.

Indexed as

Geographic AtrophyMacular DegenerationAngiogenesis InhibitorsFluorescein AngiographyHumansPeptidesRanibizumabTomography, Optical CoherenceVascular Endothelial Growth Factor AVisual AcuityAngiogenesis InhibitorsPeptidesRanibizumabrisuteganibVascular Endothelial Growth Factor AAMDDry AMDEllipsoid zoneGeographic atrophyImage analysisMachine learningOCTRisuteganib

Identifiers

PMID35569763
PMCPMC9637705
OpenAlexW4280493602

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.