Evidence mapPaperPMID 34675477Full record

Trial reportClinical ophthalmology (Auckland, N.Z.)2021

Multicenter, Prospective, Randomized Study of Dexamethasone Intravitreal Implant in Patients with Center-Involved Diabetic Macular Edema in the Asia-Pacific Region.

Wenbin Wei, Youxin Chen, Bojie Hu, Mingwei Zhao, Mei Han, Hong Dai, Harvey S Uy, Michelle Y Chen, Kate Wang, Jenny Jiao and 2 more

Open access · goldAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Clinical ophthalmology (Auckland, N.Z.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.7field-weighted citation impact, top 30% 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, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  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

12 authors at 7 institutions in 4 countries.

Wenbin WeiBeijing Tongren Hospital, Capital Medical University, Beijing, People's Republic of China.
Youxin ChenPeking Union Medical College Hospital, Beijing, People's Republic of China.
Bojie HuTianjin Medical University Eye Hospital, Tianjin, People's Republic of China.
Mingwei ZhaoPeking University People's Hospital, Beijing, People's Republic of China.
Mei HanTianjin Eye Hospital, Tianjin, People's Republic of China.
Hong DaiBeijing Hospital, Beijing, People's Republic of China.
Harvey S UyPeregrine Eye and Laser Institute, Makati City, Philippines.ORCID 0000-0002-2514-1278
Michelle Y ChenAllergan, an AbbVie company, Irvine, CA, USA.
Kate WangAllergan, an AbbVie company, Irvine, CA, USA.
Jenny JiaoAllergan, an AbbVie company, Irvine, CA, USA.
Jean LouAllergan, an AbbVie company, Irvine, CA, USA.
Xiao-Yan LiAllergan, an AbbVie company, Irvine, CA, USA.
AbbVie (United States) · USTianjin Medical University Eye Hospital · CNBeijing Hospital · CNBeijing Tongren Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNPeking University · CNPeregrine Eye and Laser Institute · PH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the safety and efficacy of dexamethasone intravitreal implant 0.7 mg (DEX) compared with laser photocoagulation in patients with diabetic macular edema (DME). PATIENTS AND

methodsThis Phase 3, multicenter, randomized, efficacy evaluator-masked, parallel-group, 12-month clinical study enrolled adults in China and the Philippines with reduced visual acuity secondary to fovea-involved DME in the study eye. Participants were randomized 1:1 to study eye treatment with laser photocoagulation every 3 months as needed (n = 139) or DEX every 5 months (n = 145). The main efficacy measures were best-corrected visual acuity (BCVA), central retinal thickness (CRT), and leakage area. The primary endpoint was the average change in BCVA from baseline over 12 months (area-under-the-curve method). Preplanned subgroup analyses evaluated outcomes in Chinese patients.

resultsMean average change in BCVA from baseline during the study (letters) was 4.3 with DEX (n = 145) versus 1.4 with laser (n = 127) overall (

conclusionDEX administered every 5 months provided significantly greater improvement in BCVA, CRT, and total leakage area compared with laser treatment. DEX demonstrated an acceptable safety profile, consistent with an intraocular corticosteroid, and similar to that reported in completed global registration studies.

Indexed as

central retinal thicknesscorticosteroiddexamethasonediabetic retinopathydrug delivery devicelaser photocoagulationmacular edemarandomized controlled trialvisual acuity

Identifiers

PMID34675477
PMCPMC8520964
OpenAlexW3206879904

What Socratic holds

Textmetadata
LicenceCC BY-NC
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 Socratic graph.