Evidence map›Paper›PMID 30680768›Full record

Trial reportBritish journal of clinical pharmacology2019

Treatment of exudative age-related macular degeneration with aflibercept combined with pranoprofen eye drops or nutraceutical support with omega-3: A randomized trial.

Francesco Semeraro, Elena Gambicordi, Anna Cancarini, Francesco Morescalchi, Ciro Costagliola, Andrea Russo

Abstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
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

12 citing papers in PubMed.

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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.

Francesco SemeraroEye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.
Elena GambicordiEye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.
Anna CancariniEye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.
Francesco MorescalchiEye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.
Ciro CostagliolaEye Clinic, Department of Health Sciences, University of Molise, Campobasso, Italy.
Andrea RussoEye Clinic, Department of Neurological and Vision Sciences, University of Brescia, Italy.ORCID 0000-0002-1566-3662

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe aim of this study was to determine whether a combination of intravitreal aflibercept (IVA) and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization (CNV) in age-related macular degeneration.

methodsThis was a prospective, randomized, pilot study in 60 patients with treatment-naïve CNV. Patients were randomized 1:1:1 into three groups: aflibercept monotherapy (AM), aflibercept plus pranoprofen (AP) or aflibercept plus nutraceutical (AN) tablets containing multivitamin antioxidant and mineral supplementation plus omega-3.

resultsAt 12 months, all groups showed significant improvement in both best-corrected visual acuity (BCVA) and central retinal thickness (CRT). The mean BCVA change from baseline to 12 months was -0.26 ± 0.06 LogMAR, -0.30 ± 0.06 LogMAR and -0.24 ± 0.04 LogMAR in the AM, AP and AN groups, respectively. The mean CRT change from baseline to 12 months was -76.9 ± 10.9 μm, -129 ± 19.9 μm and -105 ± 11.6 μm in the AM, AP and AN groups, respectively. The AN group required one less IVA injection than the AM group.

conclusionsCompared with AM, both combination groups acted synergistically, although no significant benefits in BCVA were found over AM. Nutraceutical support with omega-3 leads to a reduced need for IVA.

Indexed as

Dietary SupplementsAdministration, OralAgedAged, 80 and overBenzopyransDrug SynergismDrug Therapy, CombinationFatty Acids, Omega-3FemaleHumansIntravitreal InjectionsMacular DegenerationMaleMiddle AgedOphthalmic SolutionsPilot ProjectsafliberceptBenzopyransFatty Acids, Omega-3Ophthalmic SolutionsPropionatespyranoprofenReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTabletsVascular Endothelial Growth Factor AVEGFA protein, humanVitaminsafliberceptage-related macular degenerationmultivitamin antioxidantomega-3pranoprofen

Identifiers

PMID30680768
PMCPMC6475693

What OpenQuestion holds

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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.