Evidence map›Paper›PMID 30645696›Full record

Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2019

Efficacy and safety of ranibizumab 0.5 mg in Chinese patients with visual impairment due to diabetic macular edema: results from the 12-month REFINE study.

Xiaoxin Li, Hong Dai, Xiaorong Li, Mei Han, Jun Li, Andrea Suhner, Renxin Lin, Sebastian Wolf, REFINE study group

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 5 pooled it
3.3field-weighted citation impact, top 9% 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

21 citing papers in PubMed, 5 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
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  3. A systematic review and meta-analysis of the effect of intravitreal VEGF inhibitors on cardiorenal outcomes.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2023
    Pooled it
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  6. Article
  7. Article
  8. Recent advances in the study of Conbercept for diabetic macular edema.International journal of retina and vitreous · 2025
    Review
  9. Safety of an Intravitreal Bevacizumab Biosimilar (MVASI).Clinical & experimental ophthalmology · 2025
    Article
  10. Article
  11. Review
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  20. A meta-analysis of clinical outcomes in diabetic macular edema.Advances in ophthalmology practice and research
    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

9 authors at 4 institutions in 2 countries.

Xiaoxin LiDepartment of Ophthalmology, Peking University People's Hospital, No. 11 Xi Zhi Men South Ave., Xicheng District, Beijing, 100044, China. drlixiaoxin@163.com.
Hong DaiDepartment of Ophthalmology, Beijing Hospital, National Center of Gerontology, Beijing, China.
Xiaorong LiTianjin Medical University Eye Hospital, Tianjin, China.
Mei HanTianjin Eye Hospital, Tianjin, China.
Jun LiNovartis Pharma AG, Basel, Switzerland.
Andrea SuhnerNovartis Pharma AG, Basel, Switzerland.
Renxin LinChina Novartis Institutes for BioMedical Research Co. Ltd., Shanghai, China.
Sebastian WolfDepartment of Ophthalmology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
REFINE study group
Novartis (Switzerland) · CHPeking University · CNUniversity of Bern · CHBeijing Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo demonstrate the efficacy and safety of ranibizumab 0.5 mg pro re nata (PRN) versus laser photocoagulation for the treatment of Chinese patients with visual impairment due to diabetic macular edema (DME).

methodsREFINE was a phase III, 12-month, double-masked, multicenter, laser-controlled study in patients (aged ≥ 18 years) with DME. Patients were randomized 4:1 to receive either ranibizumab 0.5 mg or laser dosing regimen. Efficacy was evaluated as mean average change in best-corrected visual acuity (BCVA) from Months 1 to 12 versus baseline (primary endpoint), anatomical outcomes, treatment exposure, and safety were also assessed.

resultsRanibizumab was statistically superior (p < 0.001) to laser treatment, with a mean average BCVA gain of 6.8 letters (ranibizumab) over 12 months versus 1.1 letters (laser). At Month 12, mean BCVA gain was 7.8 letters (ranibizumab) and 2.5 letters (laser) from baseline. Patients in the ranibizumab arm received a mean number of 7.9 intravitreal injections, whereas those in the laser arm received a mean of 2.1 treatments. There were no new safety signals.

conclusionRanibizumab 0.5 mg PRN demonstrated a statistically significant and clinically meaningful treatment effect versus laser and was well tolerated in Chinese patients with visual impairment due to DME over 12 months.

Indexed as

Visual AcuityAgedAngiogenesis InhibitorsChinaDiabetic RetinopathyDose-Response Relationship, DrugFemaleFluorescein AngiographyFollow-Up StudiesFundus OculiHumansIncidenceIntravitreal InjectionsMacula LuteaMacular EdemaMaleAngiogenesis InhibitorsRanibizumabVascular Endothelial Growth Factor AAnti-vascular endothelial growth factorDiabetic macular edemaPro re nataRanibizumab

Identifiers

PMID30645696
OpenAlexW2909918938

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.