Observational studyThe British journal of ophthalmology2021
Two-year interim safety results of the 0.2 µg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: the observational PALADIN study.
Observational study in The British journal of ophthalmology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02424019 (A Phase 4 Safety Study of IOP Signals in Patients Treated With ILUVIEN®), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
A Phase 4 Safety Study of IOP Signals in Patients Treated With ILUVIEN® (Fluocinolone Acetonide Intravitreal Implant) 0.19 mg
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Fluocinolone acetonide vitreous insert for chronic diabetic macular oedema: a systematic review with meta-analysis of real-world experience.Scientific reports · 2021Pooled it
- Injectable in-situ Forming Lipid Liquid Crystal for Long-acting Fluocinolone Release in Posterior Ocular Therapy: In-vitro and In-vivo Evaluations.Pharmaceutical research · 2026Article
- Efficacy and Safety Outcomes of Fluocinolone Acetonide Intravitreal Implant in Refractory Diabetic Macular Edema: A Real-World Study.Ophthalmology and therapy · 2026Article
- Impact of baseline visual acuity, time-in-range and early treatment on functional outcomes in DMO: insights from the IRISS outcomes.Eye (London, England) · 2026Article
- Efficacy of fluocinolone acetonide implant in diabetic macular edema patients previously treated with dexamethasone implant: A systematic review and meta-analysis.Pakistan journal of medical sciences · 2025Article
- What have we learned from a decade treating patients with diabetic macular oedema with 0.19 mg fluocinolone acetonide intravitreal implant?Eye (London, England) · 2025Review
- Suboptimal outcomes and treatment burden of anti-vascular endothelial growth factor treatment for diabetic macular oedema in phakic patients.Eye (London, England) · 2024Article
- Effectiveness and safety of fluocinolone acetonide intravitreal implant in diabetic macular edema patients considered insufficiently responsive to available therapies (REACT): a prospective, non-randomized, and multicenter study.International ophthalmology · 2023Observational
- Fluocinolone Acetonide Implant Injected 1 Month after Dexamethasone Implant for Diabetic Macular Oedema: the ILUVI1MOIS Study.Ophthalmology and therapy · 2023Article
- Factors associated with the response to fluocinolone acetonide 0.19 mg in diabetic macular oedema evaluated as the area-under-the-curve.Eye (London, England) · 2023Article
- Management of Patients with Diabetic Macular Edema Switched from Dexamethasone Intravitreal Implant to Fluocinolone Acetonide Intravitreal Implant.Pharmaceutics · 2022Article
- Intravitreal Corticosteroid Implantation in Diabetic Macular Edema: Updated European Consensus Guidance on Monitoring and Managing Intraocular Pressure.Ophthalmology and therapy · 2022Article
- Recent Advancements in the Medical Treatment of Diabetic Retinal Disease.International journal of molecular sciences · 2021Review
- Intraocular Pressure Changes Are Predictive of Ocular Hypertension Onset After Fluocinolone Acetonide Implant: Significant Cutoffs and the Role of Previous DEX Implant.Frontiers in medicine · 2021Article
- Treatment choices for diabetic macular oedema: a guideline for when to consider an intravitreal corticosteroid, including adaptations for the COVID-19 era.BMJ open ophthalmology · 2021Review
- Long-Term Control of Retinal Thickness Variability and Vision Following the 0.19 mg Fluocinolone Acetonide Implant.Journal of vitreoretinal diseasesArticle
Corrections and comments
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Authors and funding
7 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 0.2 µg/day fluocinolone acetonide (FAc) implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular oedema (DMO). This ongoing, 3-year, observational clinical trial provides long-term, 'real-world' safety results for the FAc implant in DMO.
methodsThis 24-month interim analysis of a prospective, observational study investigated patients with DMO receiving the commercially available intravitreal 0.2 µg/day FAc implant. The primary outcome was incidence of intraocular pressure (IOP)-lowering procedures. Other IOP-related signals and their relationship to previous corticosteroid exposure, best-corrected visual acuity, central subfield thickness (CST), ocular adverse events and frequency of other treatments were also measured.
resultsData were collected from 95 previously steroid-challenged patients (115 study eyes) for up to 36 months pre-FAc and 24 months post-FAc implant. Mean IOP for the overall population remained stable post-FAc compared with pre-FAc implant. IOP-related procedures remained infrequent (two IOP-lowering surgeries pre-FAc; two trabeculoplasties and four IOP-lowering surgeries post-FAc). Mean visual acuity was stable post-FAc (mean improvement of 1-3 letters) and fewer DMO treatments were required per year following FAc implant. Mean CST was significantly reduced at 24 months post-FAc implant (p<0.001) and the percentage of patients with CST ≤300 µm was significantly increased (p=0.041).
conclusionFew IOP-related procedures were reported during the 24 months post-FAc implant. Positive efficacy outcomes were noted after treatment, with stabilisation of vision and reduction in inflammation, demonstrated by CST. The FAc implant has a favourable benefit-risk profile in the management of DMO, especially when administered after a prior steroid challenge. TRIAL REGISTRATION NUMBER: NCT02424019.
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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.