Evidence map›Paper›PMID 30095536›Full record

Trial reportJournal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society2019

Initial Impairment and Recovery of Vision-Related Functioning in Participants With Acute Optic Neuritis From the RENEW Trial of Opicinumab.

Jennifer Petrillo, Laura Balcer, Steven Galetta, Yi Chai, Lei Xu, Diego Cadavid

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.6field-weighted citation impact, top 11% 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

13 citing papers in PubMed, 21 citations in OpenAlex.

  1. Review
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  4. Interpretation of the Visual Field in Neuro-ophthalmic Disorders.Current neurology and neuroscience reports · 2024
    Review
  5. Article
  6. Review
  7. Antibody Therapies for Progressive Multiple Sclerosis and for Promoting Repair.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  8. Review
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  11. Article
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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

6 authors at 1 institution in 1 country.

Jennifer PetrilloDepartment of Value and Access (JP), Biostatistics (YC, LX), and Clinical Development (DC), Biogen, Cambridge, Massachusetts; and Departments of Neurology, Population Health, and Ophthalmology (LB and SG), New York University School of Medicine, New York, New York.
Laura Balcer
Steven Galetta
Yi Chai
Lei Xu
Diego Cadavid
Biogen (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLeucine-rich repeat and immunoglobulin domain-containing Nogo receptor-interacting protein 1 (LINGO-1) is a key suppressor of oligodendrocyte differentiation and axonal remyelination and regeneration. This analysis evaluated the potential benefit of opicinumab, a human monoclonal antibody against LINGO-1, vs placebo on exploratory clinical endpoints of patient-reported vision-related functioning and high-contrast visual acuity (HCVA) in RENEW participants with acute optic neuritis (AON).

methodsParticipants were randomized to 100 mg/kg opicinumab intravenous or placebo every 4 weeks (6 infusions). Assessments were conducted in the per-protocol (PP) population and included: 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25), 10-item Neuro-Ophthalmic Supplement (NOS-10), and HCVA.

resultsThe opicinumab group (n = 33) had worse mean (SD) baseline patient-reported vision-related functioning scores vs placebo (n = 36): NEI-VFQ-25 composite, 75.5 (17.6) vs 79.0 (16.6); NOS-10 composite, 63.6 (19.8) vs 69.8 (21.2), respectively. By Week 24, the placebo and opicinumab groups experienced substantial mean improvements from baseline (NEI-VFQ-25 composite, 15.17 vs 13.51 [difference (95% CI): -1.66 (-5.11 to 1.78)]; NOS-10 composite, 17.40 vs 16.04 [difference (95% CI): -1.35 (-7.38 to 4.67)]). Between-treatment differences in mean change from baseline were not significantly different at any time point. Analysis of covariance-adjusted mean recovery from baseline in HCVA at Week 24 for the affected eyes was 11.8 and 8.7 letters for placebo and opicinumab, respectively (P = 0.202).

conclusionsMost participants in the RENEW PP population demonstrated substantial recovery from baseline in patient-reported vision-related functioning and HCVA, regardless of treatment and structural damage. Average scores after recovery remained lower than those of published disease-free control groups. These results provide important information on visual function recovery in patients with AON, as measured by NEI-VFQ-25 and NOS-10.

Indexed as

Persons with Visual DisabilitiesAcute DiseaseAdolescentAdultAntibodies, MonoclonalDouble-Blind MethodFemaleHumansInfusions, IntravenousMaleMembrane ProteinsMiddle AgedMultiple SclerosisNerve Tissue ProteinsOptic NeuritisQuality of LifeAntibodies, MonoclonalLINGO1 protein, humanMembrane ProteinsNerve Tissue Proteinsopicinumab

Identifiers

PMID30095536
PMCPMC6530972
OpenAlexW2885964448

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.