Evidence map›Paper›PMID 29631435›Full record

Trial reportEuropean journal of ophthalmology2018

A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion.

Francesco Bandello, Albert Augustin, Adnan Tufail, Richard Leaback

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in European journal of ophthalmology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01427751 (Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion), which is not on this map. Cited by 27 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 8 pooled it
5.4field-weighted citation impact, top 4% 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.

NCT01427751 phase4completednot on this map

Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion

TypeinterventionalSponsorAllerganRan2011 to 2014Enrolled307ConditionsRetinal Vein Occlusion, Macular EdemaArmsdexamethasone intravitreal implant, ranibizumab
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 8 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. 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
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Review
  12. Review
  13. Observational
  14. Article
  15. Review
  16. Review
  17. Article
  18. Article
  19. Article
  20. Real-life study of the use of anti-VEGF therapy versus dexamethasone implant for treatment of macular edema in retinal vein occlusion.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2021
    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

4 authors at 3 institutions in 2 countries.

Francesco Bandello1 Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele, Milan, Italy.
Albert Augustin2 Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.
Adnan Tufail3 Moorfields Eye Hospital, London, UK.
Richard Leaback4 Allergan Limited, Marlow, UK.
Allergan (United Kingdom) · GBStädtisches Klinikum Karlsruhe · DEUniversity College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purpose: Dexamethasone intravitreal implant and intravitreal ranibizumab are indicated for the treatment of macular edema secondary to retinal vein occlusion. This non-inferiority study compared dexamethasone with ranibizumab in patients with branch retinal vein occlusion.

methods: In this randomized, 12-month head-to-head comparison, subjects with branch retinal vein occlusion were assigned to dexamethasone 0.7 mg at day 1 and month 5 with the option of retreatment at month 10 or 11, or ranibizumab 0.5 mg at day 1 and monthly through month 5 with subsequent as-needed injections at month 6-month 11. The primary efficacy outcome was the mean change from baseline in best-corrected visual acuity at month 12; secondary outcomes included average change in best-corrected visual acuity, proportion of eyes with ≥10- and ≥15-letter gain/loss, change in central retinal thickness, and change in Vision Functioning Questionnaire-25 score.

results: In all, 307 of a planned 400 patients were enrolled in the study and received (mean) 2.5 dexamethasone injections (n = 154) and 8.0 ranibizumab injections (n = 153) over 12 months. The mean change from baseline in best-corrected visual acuity at month 12 was 7.4 letters for dexamethasone versus 17.4 letters for ranibizumab (least-squares mean difference (dexamethasone minus ranibizumab), -10.1 letters; 95% confidence interval, -12.9, -7.2; p = 0.0006).

conclusion: Dexamethasone and ranibizumab improved best-corrected visual acuity and anatomical outcomes; however, dexamethasone did not show non-inferiority to ranibizumab in this under-powered study. Dexamethasone was associated with an increased risk of intraocular pressure elevation and cataract progression, but a lower injection burden, compared to ranibizumab.

Indexed as

Retinal Vein OcclusionAdultAgedAged, 80 and overAngiogenesis InhibitorsDexamethasoneDrug ImplantsFemaleGlucocorticoidsHumansIntravitreal InjectionsMacular EdemaMaleMiddle AgedRanibizumabVisual AcuityAngiogenesis InhibitorsDexamethasoneDrug ImplantsGlucocorticoidsRanibizumabBranch retinal vein occlusiondexamethasone intravitreal implantnon-inferiority studyranibizumab

Identifiers

PMID29631435
PMCPMC6210573
OpenAlexW2895675601

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.