Evidence map›Paper›PMID 35802252›Full record

ArticleOphthalmology and therapy2022

Real-Life Efficacy, Safety, and Use of Dexamethasone Intravitreal Implant in Posterior Segment Inflammation Due to Non-infectious Uveitis (LOUVRE 2 Study).

Bahram Bodaghi, Antoine P Brézin, Michel Weber, Cécile Delcourt, Laurent Kodjikian, Alexandra Provost, Marie-Ève Velard, Doris Barnier-Ripet, Sybil Pinchinat, Laure Dupont-Benjamin

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02951975 (Multicentre Longitudinal Study of the Prescription of Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
3.1field-weighted citation impact, top 8% 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.

NCT02951975 terminatednot on this map

Multicentre Longitudinal Study of the Prescription of Ozurdex® in Patients With Non-infectious Uveitis Affecting the Posterior Segment of the Eye

TypeobservationalSponsorAllerganRan2017 to 2018Enrolled246ConditionsNon-infectious UveitisArmsdexamethasone intravitreal implant
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Functional and Morphological Responses to Fluocinolone Acetonide 0.19 mg in Noninfectious Uveitic Macular Edema Evaluated as the Area-Under-the-Curve.Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2023
    Article
  5. Article
  6. 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

10 authors at 7 institutions in 2 countries.

Bahram BodaghiAPHP Department of Ophthalmology, IHU FOReSIGHT, Pitié-Salpêtrière Hospital, Sorbonne University, 47-83 Boul. de l'Hôpital, 75013, Paris, France. bahram.bodaghi@aphp.fr.ORCID http://orcid.org/0000-0002-0962-5301
Antoine P BrézinCentre d'ophtalmologie de l'Assistance Publique, Hôpitaux de Paris, Hôpital Cochin, Université de Paris, Paris, France.ORCID http://orcid.org/0000-0001-8461-3119
Michel WeberCentre Hospitalier Universitaire de Nantes, Nantes, France.
Cécile DelcourtINSERM, Bordeaux Population Health Research Center, UMR 1219, Université de Bordeaux, Bordeaux, France.ORCID http://orcid.org/0000-0002-2099-0481
Laurent KodjikianLa Croix-Rousse Hospital, University Hospital of Lyon, Lyon, France.ORCID http://orcid.org/0000-0002-3908-6716
Alexandra ProvostAllergan, an AbbVie company, Courbevoie, France.ORCID http://orcid.org/0000-0001-7103-234X
Marie-Ève VelardAllergan, an AbbVie company, Courbevoie, France.
Doris Barnier-RipetAxonal-Biostatem, Castries, France.
Sybil PinchinatAxonal-Biostatem, Castries, France.
Laure Dupont-BenjaminAllergan, an AbbVie company, Courbevoie, France.ORCID http://orcid.org/0000-0001-7748-0768
AbbVie (Ireland) · IEAudionamix (France) · FRCentre Hospitalier Universitaire de Nantes · FRHôpital Cochin · FRSorbonne Université · FRUniversité Claude Bernard Lyon 1 · FRUniversité de Bordeaux · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo evaluate real-life efficacy, safety, and treatment patterns with the dexamethasone intravitreal implant (DEX) in posterior segment inflammation due to non-infectious uveitis (treatment-naïve or not) in French clinics.

methodsIn this prospective, multicenter, observational, non-comparative, post-reimbursement study, consecutive patients with posterior segment inflammation due to non-infectious uveitis were enrolled and evaluated at baseline (day 0). Those who received DEX on day 0 were re-evaluated at months 2, 6, and 18. Retreatment with DEX and/or alternative therapies was allowed during follow-up. PRIMARY OUTCOME: patients (%) with at least a 15-letter gain in best corrected visual acuity (BCVA) at 2 months. Secondary outcomes included patients (%) with at least 15-letter BCVA gains at 6 and 18 months; mean BCVA change from baseline at 2, 6, and 18 months; and patients (%) retreated, mean central retinal thickness (CRT), and adverse events (AEs) at all post-baseline visits.

resultsNinety-seven of 245 enrolled patients with posterior segment inflammation due to non-infectious uveitis (80% previously treated) and disease duration of 5 years (average) received DEX on day 0 and were included in efficacy analyses. At month 2 (n = 91), 20.5% of patients (95% CI 12.0-28.9) gained at least 15 letters from a baseline mean of 60.9 letters; the mean gain was 6.2 letters (95% CI 3.5-8.9). At month 6, 50.0% (n = 38/76) of patients did not receive alternative treatment or DEX retreatment, mostly because inflammation had sufficiently subsided (n = 27/38, 71.1%). Although early study termination prevented efficacy analysis at 18 months (n = 12), CRT reductions persisted throughout follow-up. From baseline to month 18, 21/245 (8.6%) patients had DEX-related AEs; 17/245 (6.9%) had ocular hypertension (most common AE).

conclusionLOUVRE 2 confirms DEX efficacy on visual acuity and CRT in predominantly DEX-pretreated patients with relatively old/stabilized uveitis. DEX tolerability was consistent with known/published data, confirming treatment benefits in posterior segment inflammation due to non-infectious uveitis. CLINICALTRIALS: GOV IDENTIFIER: NCT02951975.

Indexed as

DexamethasoneFranceIntravitrealReal-world evidenceUveitis

Identifiers

PMID35802252
PMCPMC9437191
OpenAlexW4284964474

What OpenQuestion 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 OpenQuestion graph.