Evidence map›Paper›PMID 35456557›Full record

ArticlePharmaceutics2022

Efficacy and Safety of Intravitreal Fluocinolone Acetonide Implant for Chronic Diabetic Macular Edema Previously Treated in Real-Life Practice: The REALFAc Study.

Thibaud Mathis, Maxence Papegaey, Cécile Ricard, Amina Rezkallah, Frédéric Matonti, Aditya Sudhalkar, Cristina Vartin, Corinne Dot, Laurent Kodjikian

Open access · goldAbstract read
In one paragraph

Article in Pharmaceutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
4.1field-weighted citation impact, top 5% 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

16 citing papers in PubMed, 23 citations in OpenAlex.

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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 1 country.

Thibaud MathisService d'Ophtalmologie, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, 69004 Lyon, France.ORCID 0000-0002-1418-1872
Maxence PapegaeyService d'Ophtalmologie, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, 69004 Lyon, France.
Cécile RicardStatMed74, 74000 Annecy, France.
Amina RezkallahService d'Ophtalmologie, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, 69004 Lyon, France.
Frédéric MatontiCentre Monticelli Paradis, 13008 Marseille, France.ORCID 0000-0002-6180-3937
Aditya SudhalkarAlphavision Augenzentrum, 27568 Bremerhaven, Germany.
Cristina VartinService d'Ophtalmologie, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, 69004 Lyon, France.
Corinne DotService d'Ophtalmologie, Hôpital Militaire Desgenettes, 69003 Lyon, France.ORCID 0000-0003-4398-3978
Laurent KodjikianService d'Ophtalmologie, Hôpital de la Croix-Rousse, Hospices Civils de Lyon, 69004 Lyon, France.ORCID 0000-0002-3908-6716
Hôpital de la Croix-Rousse · FRUniversité Claude Bernard Lyon 1 · FRCentre National de la Recherche Scientifique · FRHIA du Val-de-Grâce à Paris · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Diabetic macular edema (DME) is the main cause of visual impairment in diabetic patients and a chronic disease requiring long-term treatments. The fluocinolone acetonide (FAc) implant has recently been approved to treat DME in patients considered insufficiently responsive to available therapies. This study evaluates the functional and anatomical efficacy of the FAc implant in real-life practice. A total of 62 eyes with chronic DME were included and followed for a mean of 13.9 (+7.5) months. Previous treatment included at least anti-vascular endothelial growth factor (VEGF) in 83.9% of eyes, dexamethasone implant (DEX-I) in 100% of eyes, vitrectomy in 29.0% of eyes, and laser photocoagulation (either panretinal or focal photocoagulation) in 75.8% of eyes. The mean baseline best corrected visual acuity (BCVA) was 64.0 (+/−17.2) letters (median: 67.5 letters) with a mean DME duration of 60.3 (+/−30.6) months. The maximum BCVA gain occurred at 21 months with a mean gain of 5.0 (+/−12.7) letters. A total of 50.0% of eyes gained ≥5 letters during follow-up. Patients with lower BCVA at baseline had the lowest final BCVA (p < 0.001) but the highest BCVA gain (p = 0.02). The best overall improvement in mean central macular thickness (CMT) occurred at 18 months (p < 0.0001). The improvement in BCVA was inversely associated with the decrease in CMT and showed a decrease when CMT increased (DME recurrence). According to the history of vitrectomy, we did not find any significant difference in mean final BCVA (p = 0.1) and mean BCVA gain (p = 0.2) between eyes previously vitrectomized or not. A total of 23 eyes (37.1%) required additional treatment for DME, and 17.7% required an IOP-lowering procedure during follow-up. In conclusion, this real-life observational study demonstrated the efficacy and safety of the FAc implant in patients with chronic DME already treated with other available therapies.

Indexed as

corticosteroids intravitreal injectiondiabetic macular edemadiabetic retinopathyfluocinolone acetonide implant

Identifiers

PMID35456557
PMCPMC9025285
OpenAlexW4220799991

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.