Evidence map›Paper›PMID 30341774›Full record

Trial reportBritish journal of clinical pharmacology2019

The Developing Regorafenib Eye drops for neovascular Age-related Macular degeneration (DREAM) study: an open-label phase II trial.

Antonia M Joussen, Sebastian Wolf, Peter K Kaiser, David Boyer, Thomas Schmelter, Rupert Sandbrink, Oliver Zeitz, Gesa Deeg, Annett Richter, Torsten Zimmermann and 5 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
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 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
–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

34 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Topical Treatment for Retinal Degenerative Pathologies: A Systematic Review.International journal of molecular sciences · 2023
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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

15 authors.

Antonia M JoussenDepartment of Ophthalmology, Charité - University Medicine Berlin, Berlin, Germany.
Sebastian WolfBern Photographic Reading Center and Department of Ophthalmology, Inselspital, University Hospital, University of Bern, Bern, Switzerland.
Peter K KaiserCole Eye Institute, Cleveland, OH, USA.
David BoyerRetina-Vitreous Associates Medical Group, Beverly Hills, CA, USA.
Thomas SchmelterBayer AG, Division Pharma, Berlin and Wuppertal, Germany.
Rupert SandbrinkBayer AG, Division Pharma, Berlin and Wuppertal, Germany.
Oliver ZeitzDepartment of Ophthalmology, Charité - University Medicine Berlin, Berlin, Germany.
Gesa DeegBayer AG, Division Pharma, Berlin and Wuppertal, Germany.
Annett RichterBayer AG, Division Pharma, Berlin and Wuppertal, Germany.
Torsten ZimmermannBayer AG, Division Pharma, Berlin and Wuppertal, Germany.
Joachim HoechelBayer AG, Division Pharma, Berlin and Wuppertal, Germany.
Ulf BuetehornBayer AG, Division Pharma, Berlin and Wuppertal, Germany.
Walter SchmittBayer AG, Division Pharma, Berlin and Wuppertal, Germany.
Brigitte StemperBayer AG, Division Pharma, Berlin and Wuppertal, Germany.
Michael K BoettgerBayer AG, Division Pharma, Berlin and Wuppertal, Germany.ORCID 0000-0002-6123-2142

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis programme investigated topical regorafenib, a multikinase inhibitor, in patients with neovascular age-related macular degeneration (nAMD).

methodsTopical regorafenib was investigated in an open-label, phase IIa/b study in which patients with choroidal neovascularization (CNV) secondary to nAMD received regorafenib (25 μl, 30 mg ml

resultsIn nAMD patients (N = 51), mean changes in BCVA were +1.2 [90% confidence interval (CI) -0.61, 2.97] and -2.4 (90% CI -4.18, -0.54) letters at weeks 4 and 12, respectively. Ocular treatment-emergent adverse events (TEAEs) (study eye) were reported in 21 patients by week 12. There was one serious ocular TEAE (visual acuity reduced) that was not drug related. Twenty patients required rescue (intravitreal ranibizumab).

conclusionsThe programme was terminated after phase IIa ended because efficacy was lower than with current nAMD treatments. According to elaborate post hoc analyses, the most likely reason was insufficient exposure in the target compartment (back of the eye).

Indexed as

Administration, OphthalmicAgedAged, 80 and overAngiogenesis InhibitorsFemaleHumansMacular DegenerationMaleOphthalmic SolutionsPhenylurea CompoundsPyridinesTreatment OutcomeVisual AcuityAngiogenesis InhibitorsOphthalmic SolutionsPhenylurea CompoundsPyridinesregorafenibclinical trialsdrug developmentophthalmologypharmacometrics

Identifiers

PMID30341774
PMCPMC6339971

What OpenQuestion holds

Textmetadata
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.