Evidence map›Paper›PMID 32492069›Full record

Observational studyPloS one2020

Effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema: Results from the real-world global LUMINOUS study.

Paul Mitchell, Tom G Sheidow, Michel E Farah, Sajjad Mahmood, Angelo M Minnella, Nicole Eter, Bora Eldem, Hassan Al-Dhibi, Wayne Macfadden, Soumil Parikh and 4 more

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
6.5field-weighted citation impact, top 2% 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

31 citing papers in PubMed, 55 citations in OpenAlex.

  1. Trial
  2. Nonadherence to anti-VEGF intravitreal injections in patients with diabetic macular edema : The names of the authors.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
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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

14 authors at 10 institutions in 11 countries.

Paul MitchellCentre for Vision Research, Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, Sydney, NSW, Australia.ORCID 0000-0003-2470-3790
Tom G SheidowIvey Eye Institute, Schulich School of Medicine, Western University, Ontario, Canada.
Michel E FarahDepartment of Ophthalmology, Federal University of São Paulo, Paulista School of Medicine, São Paulo, Brazil.ORCID 0000-0001-5951-0193
Sajjad MahmoodRoyal Eye Hospital, Oxford Road, Manchester, United Kingdom.
Angelo M MinnellaInstitute of Ophthalmology, Catholic University "Sacro Cuore" Foundation "A. Gemelli", Rome, Italy.
Nicole EterDepartment of Ophthalmology, University of Muenster Medical Center, Muenster, Germany.
Bora EldemDepartment of Ophthalmology, Hacettepe University, Faculty of Medicine, Sıhhiye, Ankara, Turkey.
Hassan Al-DhibiVitreoretinal and Uveitis Division, King Khaled Eye Specialist Hospital, Riyadh, Kingdom of Saudi Arabia.ORCID 0000-0002-0621-1234
Wayne MacfaddenNovartis Pharma AG, Basel, Switzerland.
Soumil ParikhNovartis Pharma AG, Basel, Switzerland.
Cornelia Dunger-BaldaufNovartis Pharma AG, Basel, Switzerland.
Mohamed M MahgoubAin-Shams University, Universidad de El Cairo, Cairo, Egypt.
Ursula Schmidt-ErfurthDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
LUMINOUS study investigators
Novartis (Switzerland) · CHAin Shams University · EGHacettepe University · TRKing Khaled Eye Specialist Hospital · SAManchester Royal Eye Hospital · GBMedical University of Vienna · ATThe University of Sydney · AUUniversidade Federal de São Paulo · BRUniversità Cattolica del Sacro Cuore · ITWestern University · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess the one-year effectiveness and safety of ranibizumab 0.5 mg in treatment- naïve patients with diabetic macular edema (DME) enrolled in the real-world LUMINOUS study. PATIENTS AND

methodsA 5-year, prospective, observational, open-label, global study which recruited 30,138 patients across all approved indications. Consenting patients (≥18 years) who were treatment-naïve or previously treated with ranibizumab or other ocular treatments were treated as per the local ranibizumab label. Here, we present the change in visual acuity (VA) (Early Treatment Diabetic Retinopathy Study letter score; primary treated eye) at Year 1, as well as the change in VA based on injection frequencies (≤4 and ≥5), treatment exposure, and the overall adverse events (AEs) and serious AEs (SAEs) in treatment-naïve DME patients.

resultsOf the 4,710 DME patients enrolled in the study, 1,063 were treatment-naïve. At baseline, mean age was 64.5 years, 54.7% were male, and 69.2% were white. At 1 year, mean VA letter score improved by +3.5 (n = 502) from a baseline of 57.7 with a mean of 4.5 injections. Presented by injection frequencies ≤4 and ≥5, VA letter score gains were 0.5 (n = 264) and 6.9 (n = 238) from baseline letter scores of 56.6 and 59.0, respectively. Over 5 years, the incidence of ocular/non-ocular AEs and SAEs was 7.2%/10.1% and 0.3%/5.8%, respectively. No endophthalmitis cases were reported.

conclusionsThe LUMINOUS study included patients with DME with more diverse baseline characteristics than those in randomized clinical trials. The 1-year data showed improvement in VA with low number of injections in treatment- naïve patients with DME. Greater VA gains were observed in patients who received ≥5 injections. No new safety findings were identified. LUMINOUS confirms the effectiveness and safety of ranibizumab for the treatment of patients with DME in a real-world clinical practice.

Indexed as

AgedAged, 80 and overAngiogenesis InhibitorsDiabetic RetinopathyFemaleFollow-Up StudiesHumansIntravitreal InjectionsMacular EdemaMaleMiddle AgedProspective StudiesRanibizumabTreatment OutcomeVisual AcuityAngiogenesis InhibitorsRanibizumab

Identifiers

PMID32492069
PMCPMC7269267
OpenAlexW3030682574

What OpenQuestion holds

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LicenceCC BY
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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.