Evidence map›Paper›PMID 25999689›Full record

ArticleClinical ophthalmology (Auckland, N.Z.)2015

A novel intravitreal fluocinolone acetonide implant (Iluvien(®)) in the treatment of patients with chronic diabetic macular edema that is insufficiently responsive to other medical treatment options: a case series.

Vera K Schmit-Eilenberger

Open access · goldAbstract read
In one paragraph

Article in Clinical ophthalmology (Auckland, N.Z.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
7.1field-weighted citation impact, top 3% 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

27 citing papers in PubMed, 52 citations in OpenAlex.

  1. Review
  2. Intravitreal Fluocinolone Acetonide Implant (ILUVIENDrug design, development and therapy · 2023
    Review
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Observational
  16. Review
  17. Article
  18. Review
  19. Article
  20. Pharmacology of Corticosteroids for Diabetic Macular Edema.Investigative ophthalmology & visual science · 2018
    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

1 author at 1 institution in 1 country.

Vera K Schmit-EilenbergerAugenklinik Städtisches Klinikum, Karlsruhe, Baden-Württemberg, Germany.
Städtisches Klinikum Karlsruhe · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIluvien(®) is a novel, nonbiodegradable, sustained-release drug delivery system (0.2 μg/d fluocinolone acetonide [FAc]) indicated in Europe for the treatment of vision impairment associated with chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies.

objectiveTo evaluate the safety and efficacy of 190-μg FAc implant in patients with chronic DME refractory to other medical treatment options in a clinical setting.

methodsRetrospective registry data were collected by using standard case report forms (CRFs). Prior to intravitreal injection of the FAc implant, all patients were treated either with a vascular endothelial growth factor (VEGF) antagonist and/or a steroid (triamcinolone, dexamethasone implant). Patients were excluded from receiving FAc if they had a known history of elevated intraocular pressure (IOP) following corticosteroid therapy, glaucoma, ocular hypertension, or any contraindications cited in the summary of product characteristics. Best-corrected visual acuity (BCVA) was the main study parameter. Central fovea thickness (CFT) and IOP were measured concurrently. These parameters were recorded prior to and after the injection of the 190-μg FAc implant (between 1 week and 9 months). Injections were performed between May 2013 and March 2014.

resultsFifteen eyes from ten patients were treated. Thirteen eyes (nine patients) were pseudophakic, and seven eyes (five patients) were vitrectomized prior to receiving therapy. BCVA improved in eleven eyes (73.3%), remained unchanged in two eyes (13.3%), and decreased slightly in two eyes (13.3%) at the last follow-up visit versus baseline levels. IOP increased in two patients and was controlled using fixed-combination of IOP-lowering eyedrops or sectorial cyclocryotherapy (n=1).

conclusionThe 190-μg FAc implant was efficacious and showed a favorable benefit-to-risk profile in the patient population with chronic DME of this case series that were refractory to other therapies. The longer-term efficacy and safety in a real-life setting is still being assessed in this center. FAc may offer an important treatment option for patients with chronic DME refractory to other treatment options.

Indexed as

best-corrected visual acuitycorticosteroiddiabetic macular edemafluocinolone acetonideintravitreal implant

Identifiers

PMID25999689
PMCPMC4427264
OpenAlexW1644616870

What OpenQuestion 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 OpenQuestion graph.