Evidence map›Paper›PMID 32542431›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2020

Safety and Efficacy of Ranibizumab and Luseogliflozin Combination Therapy in Patients with Diabetic Macular Edema: Protocol for a Multicenter, Open-Label Randomized Controlled Trial.

Ryoichi Ishibashi, Yoko Takatsuna, Masaya Koshizaka, Tomoaki Tatsumi, Sho Takahashi, Kengo Nagashima, Noriko Asaumi, Miyuki Arai, Fumio Shimada, Kaori Tachibana and 8 more

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

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 32% 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

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Article
  5. Article
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

18 authors at 8 institutions in 1 country.

Ryoichi IshibashiDepartment of Medicine, Division of Diabetes, Endocrinology and Metabolism, Kimitsu Chuo Hospital, 1010 Sakurai, Kisarazu, Chiba, 292-8535, Japan. ishibashi-cib@umin.net.ORCID http://orcid.org/0000-0003-2535-5396
Yoko TakatsunaDepartment of Ophthalmology, Chiba Rosai Hospital, 2-16 Tatsumidai-Higashi, Ichihara, Chiba, 290-0003, Japan.
Masaya KoshizakaDepartment of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8677, Japan.
Tomoaki TatsumiDepartment of Ophthalmology and Vision Science, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8677, Japan.
Sho TakahashiClinical Research Support Center, The Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, 105-8461, Japan.
Kengo NagashimaResearch Center for Medical and Health Data Science, The Institute of Statistical Mathematics, 10-3 Midori-cho, Tachikawa, Tokyo, 190-8562, Japan.
Noriko AsaumiDepartment of Ophthalmology, Kimitsu Chuo Hospital, 1010 Sakurai, Kisarazu, Chiba, 292-8535, Japan.
Miyuki AraiDepartment of Ophthalmology, National Hospital Organization Chiba Medical Center, Tsubakimori 4-1-2, Chuo-ku, Chiba, Chiba, 260-8606, Japan.
Fumio ShimadaDepartment of Diabetes and Metabolism, National Hospital Organization Chiba Medical Center, Tsubakimori 4-1-2, Chuo-ku, Chiba, Chiba, 260-8606, Japan.
Kaori TachibanaDepartment of Diabetes, Metabolic Diseases, Endocrinology, Japanese Red Cross Narita Hospital, 90-1, Iida-cho, Narita, Chiba, 286-8523, Japan.
Yoshihiro WatanabeDepartment of Ophthalmology, Japanese Red Cross Narita Hospital, 90-1, Iida-cho, Narita, Chiba, 286-8523, Japan.
Ko IshikawaDepartment of Internal Medicine, Chiba Rosai Hospital, Tatsumidai-Higashi 2-16, Ichihara, Chiba, 290-0003, Japan.
Akiko HoshinoDepartment of Ophthalmology, Chiba Aoba Municipal Hospital, Aoba-cho 1273-2, Chuo-ku, Chiba, Chiba, 260-0852, Japan.
Kyohei YamamotoDepartment of Internal Medicine, Chiba Aoba Municipal Hospital, Aoba-cho 1273-2, Chuo-ku, Chiba, Chiba, 260-0852, Japan.
Mariko Kubota-TaniaiDepartment of Ophthalmology, Chiba Kaihin Municipal Hospital, Isobe 3-31-1, Mihama-ku, Chiba, Chiba, 261-0012, Japan.
Takafumi MayamaDepartment of Internal Medicine, Chiba Kaihin Municipal Hospital, Isobe 3-31-1, Mihama-ku, Chiba, Chiba, 261-0012, Japan.
Shuichi YamamotoDepartment of Ophthalmology and Vision Science, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8677, Japan.
Koutaro YokoteDepartment of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba, Chiba, 260-8677, Japan.
Chiba University · JPChiba Aoba Municipal Hospital · JPChiba Kaihin Municipal Hospital · JPJapanese Red Cross Narita Hospital · JPNational Hospital Organization · JPChiba Rosai Hospital · JPJikei University School of Medicine · JPThe Institute of Statistical Mathematics · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDiabetic macular edema (DME) threatens daily life activities such as reading and driving and reduces the patients' quality-of-life. Recently, anti-vascular endothelial growth factor (VEGF) agents have become a first-line therapy in DME. However, therapy with anti-VEGF agents has several problems: repeated invasive injections are required; medical costs are high; and a certain proportion of patients with DME are resistant to treatment with anti-VEGF agents. While sodium-glucose co-transporter 2 (SGLT2) inhibitors have been widely used for the treatment of type 2 diabetes mellitus (T2DM), the effects of a combination therapy with anti-VEGF agent and SGLT2 inhibitor on DME are not yet known.

methodsThis study enrolls subjects with T2DM and DME, randomizes them into either a study agent treatment group (treated with ranibizumab as anti-VEGF agent and luseogliflozin as SGLT2 inhibitor) or a control group (treated with ranibizumab and glimepiride), and observes the subjects for 52 weeks after initiation of treatment. Planned outcomes: The primary endpoint is intergroup difference in the number of intravitreal anti-VEGF injections to the study eye from baseline to week 48. Secondary and exploratory endpoints include safety and ophthalmologic and internal medical clinical parameters. REGISTRATION: This study is registered at the University Hospital Medical Information Network Clinical Trial Registry (UMIN000033961) and Japan Registry of Clinical Trials (jRCTs031180210).

Indexed as

Anti-vascular endothelial growth factor agentCentral retinal thicknessDiabetic macular edemaOptical coherence tomographySodium-glucose transporter 2 inhibitor

Identifiers

PMID32542431
PMCPMC7376811
OpenAlexW3034362548

What OpenQuestion holds

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LicenceCC BY-NC
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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.