Evidence map›Paper›PMID 34326500›Full record

Trial reportEye (London, England)2022

Effectiveness and safety of ranibizumab in patients with central retinal vein occlusion: results from the real-world, global, LUMINOUS study.

Andrew Lotery, Andreas Clemens, Raman Tuli, Xun Xu, Masahiko Shimura, Marco Nardi, Focke Ziemssen, Cornelia Dunger-Baldauf, Ramin Tadayoni, LUMINOUS™ study group

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Eye (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 24% 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

6 citing papers in PubMed, 11 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

10 authors at 8 institutions in 8 countries.

Andrew LoteryClinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.ORCID 0000-0001-5541-4305
Andreas Clemens *Novartis Pharma AG, Basel, Switzerland. andreas.clemens@novartis.com.ORCID 0000-0001-6192-1557
Raman TuliDepartment of Ophthalmology, University of Ottawa, Ottawa, Canada.
Xun XuDepartment of Ophthalmology, Shanghai First People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai, China.
Masahiko ShimuraDepartment of Ophthalmology, Tokyo Medical University Hachioji Medical Center, Hachioji-shi, Tokyo-To, Japan.
Marco NardiOphthalmology Unit, University of Pisa, Pisa, Italy.
Focke ZiemssenDepartment for Ophthalmology, Eberhard Karl University Tübingen, Tübingen, Germany.ORCID 0000-0002-3873-0581
Cornelia Dunger-BaldaufNovartis Pharma AG, Basel, Switzerland.
Ramin Tadayoni *Université de Paris, Ophthalmology Department, AP-HP, Lariboisière, Saint Louis and Fondation Rothschild Hospitals, Paris, France.
LUMINOUS™ study group
Novartis (Switzerland) · CHAssistance Publique – Hôpitaux de Paris · FRShanghai First People's Hospital · CNTokyo Medical University Hachioji Medical Center · JPUniversity of Ottawa · CAUniversity of Pisa · ITUniversity of Southampton · GBUniversity of Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effectiveness, treatment patterns and long-term safety of ranibizumab 0.5 mg in treatment-naïve patients with central retinal vein occlusion (CRVO) in a real-world setting.

methodsLUMINOUS, a 5-year, global, prospective, multicentre, multi-indication, observational, open-label study, recruited treatment naïve or prior treated patients who were treated as per the local ranibizumab label. Here, we report the mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), treatment exposure over year (Y) 1 and 5-year safety in treatment-naïve CRVO patients.

resultsAt baseline, the mean age of treatment-naïve CRVO patients (n = 327) was 68.9 years, with a mean (Standard deviation [SD]) VA of 40.6 (23.9) letters. At Y1, patients (n = 144) had a mean (SD) VA gain from baseline of 10.8 (19.66) letters, with a mean (SD) of 5.4 (2.65) ranibizumab injections. Patients demonstrated mean (SD) VA gains of 2.7 (19.35), 11.6 (20.56), 13.9 (18.08), 11.1 (18.46) and 8.2 (24.86) letters with 1, 2-3, 4-5, 6-8 and >8 ranibizumab injections, respectively. Mean (SD) VA gains at Y1 in patients receiving loading (67.4%) and no loading dose (32.6%) was 11.9 (20.42) and 8.4 (17.99) letters, respectively. Over five years, the incidence of ocular/non-ocular adverse events (AEs) and serious AEs was 11.3%/8.6% and 1.2%/6.7%, respectively.

conclusionsThese results demonstrate the effectiveness of ranibizumab in treatment-naïve CRVO patients at Y1 with clinically meaningful VA gains and no new safety findings over five years. These findings may help inform routine practice and enable better clinical management to achieve optimal visual outcomes.

Indexed as

RanibizumabRetinal Vein OcclusionAgedAngiogenesis InhibitorsHumansIntravitreal InjectionsProspective StudiesTomography, Optical CoherenceTreatment OutcomeAngiogenesis InhibitorsRanibizumab

Identifiers

PMID34326500
PMCPMC9307792
OpenAlexW3183453989

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Registered trials

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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.