Evidence map›Paper›PMID 36869355›Full record

ArticleInternational journal of retina and vitreous2023

Combined intravitreal dexamethasone and bevacizumab injection for the treatment of persistent diabetic macular edema (DexaBe study): a phase I clinical study.

Francyne Veiga Reis, Pedro Dalgalarrondo, José Edisio da Silva Tavares Neto, Murilo Wendeborn Rodrigues, Ingrid U Scott, Rodrigo Jorge

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of retina and vitreous, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
2.0field-weighted citation impact, top 15% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
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 3 institutions in 2 countries.

Francyne Veiga ReisDepartment of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes av., Campus, 12fl., Ribeirão Preto, São Paulo, 14048-900, Brazil. franveigacyrino@gmail.com.ORCID http://orcid.org/0000-0002-1892-6210
Pedro DalgalarrondoDepartment of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes av., Campus, 12fl., Ribeirão Preto, São Paulo, 14048-900, Brazil.
José Edisio da Silva Tavares NetoDepartment of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes av., Campus, 12fl., Ribeirão Preto, São Paulo, 14048-900, Brazil.
Murilo Wendeborn RodriguesDepartment of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes av., Campus, 12fl., Ribeirão Preto, São Paulo, 14048-900, Brazil.
Ingrid U ScottDepartments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, PA, USA.ORCID http://orcid.org/0000-0002-3908-7153
Rodrigo JorgeDepartment of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes av., Campus, 12fl., Ribeirão Preto, São Paulo, 14048-900, Brazil. rjorge@fmrp.usp.br.ORCID http://orcid.org/0000-0002-2652-0720
Universidade de São Paulo · BRPenn State Milton S. Hershey Medical Center · USUniversidade de Ribeirão Preto · BR

Funding

CNPQ 142177/2016-4
6 · The paper itself

Abstract

purposeThe aim of this study is to investigate the safety of combined intravitreal injection of dexamethasone aqueous-solution (IVD) and bevacizumab (IVB) in patients with refractory diabetic macular edema (DME) and its effect on intraocular pressure (IOP), best-corrected visual acuity (BCVA) and central subfield thickness (CSFT).

methodsThis prospective study included 10 patients (10 eyes) with DME refractory to laser photocoagulation and/or anti-vascular endothelial growth factor (anti-VEGF) therapy. A complete ophthalmological examination was performed at baseline, during the first week of treatment, and monthly through week 24. Therapy consisted of monthly injections of combined IVD and IVB "pro re nata" (PRN) if CST > 300 µm. We investigated the impact of the injections on intraocular pressure (IOP), cataract development, Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA), and central sub-foveal thickness (CSFT) measured by spectral-domain optical coherence tomography (OCT).

resultsEight patients (80%) completed 24 weeks of follow-up. Compared to baseline, mean IOP increased significantly (p < 0.05) and anti-glaucomatous eye drops were necessary for 50% of the patients, CSFT was significantly reduced at all follow-up visits (p < 0.05), although mean BCVA showed no significant improvement. One patient developed dense cataract progression and another showed vitreoretinal traction at week 24. No inflammation or endophthalmitis was observed.

conclusionTreatment of DME refractory to laser and/or anti-VEGF therapy with combined PRN IV dexamethasone aqueous solution and bevacizumab was associated with adverse effects related to the use of corticosteroids. However, there was a significant improvement in CSFT meantime best-correct visual acuity remained stable or improved in 50% of patients.

Indexed as

Aqueous solution of dexamethasoneBevacizumabDiabetic macular edemaDiabetic retinopathyIntravitreal injectionOptical coherence tomography

Identifiers

PMID36869355
PMCPMC9985227
OpenAlexW4323041219

What Socratic holds

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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 Socratic graph.