Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 May 16;8(4):394-400.
doi: 10.1177/24741264241247624. eCollection 2024 Jul-Aug.

Real-World Outcomes of the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema

Christine Morozova  1 , Lucas L Humayun  2 , Jonathan Kasper  3 , Andy Morozov  1 , Homayoun Tabandeh  1 , David S Boyer  1 , Pouya N Dayani  1   2 , Firas M Rahhal  1   2   4
Affiliations

Real-World Outcomes of the 0.19 mg Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema

Christine Morozova et al. J Vitreoretin Dis. .

Abstract

Purpose: To evaluate the real-world clinical and safety outcomes of a 0.19 mg fluocinolone acetonide intravitreal implant to treat diabetic macular edema (DME). Methods: This retrospective analysis comprised patients treated with a single fluocinolone acetonide intravitreal implant for the clinical indication of ME secondary to diabetic retinopathy. Primary outcomes included changes in best-corrected visual acuity (BCVA), central subfield thickness (CST), and the frequency of DME-related treatments 12 months before and up to 36 months after fluocinolone acetonide administration. Safety outcomes were also assessed. Results: One hundred forty-eight eyes (115 patients) were followed for a mean (±SD) of 12.3 ± 4.2 months before and 29.4 ± 14.5 months after fluocinolone acetonide administration. A 0.8-letter decrease (Early Treatment Diabetic Retinopathy Study) in the mean BCVA was observed at month 24. The BCVA was 70 letters (20/40 Snellen equivalent) or more in 20.6% of eyes at baseline and in 23.7% of eyes 24 months after implant administration. The mean CST was 379.9 μm and 323.7 μm, respectively. The CST was 300 μm or less in 58.7% of eyes at month 24 (P < .001). The mean frequency of intravitreal antivascular endothelial growth factor injections or laser photocoagulation decreased from 4.9 to 1.5 per year after fluocinolone acetonide administration (P < .001). Implant migration to the anterior chamber occurred in 3 eyes, 2 of which were vitrectomized and later required removal. Conclusions: The 0.19 mg fluocinolone acetonide intravitreal implant provided long-term stabilization of VA and macular anatomy in patients with DME, despite a significant reduction in treatment frequency.

Keywords: Iluvien; chronic disease; diabetic macular edema; fluocinolone acetonide; implant; intravitreal implant; retrospective study.

PubMed Disclaimer

Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr. Tabandeh: Alimera Sciences (stock) and Coherus BioSciences (stock, public). Dr. Boyer: 4D Molecular Therapeutics, Achillion Pharma, Adverum Biotechnologies, AiViva Biopharma, Alcon, Aldeyra Therapeutics, Alimera, Alkahest, Allegro, Allergan, Allgenesis, Amydis, Annexon Biosciences, Apellis Pharmaceuticals, Applied Genetec Technologies Corp, AsclepiX Therapeutics, Ashvattha Therapeutics, Aviceda Therapeutics, Bausch + Lomb, Bayer, Biovisics Medical, Boehringer-Ingelheim Pharma, Cell Care Therapeutic, Chengdu Kanghong Biotechnology, Clearside Biomedical, Curacle Co Ltd, Delsitech, EyePoint Pharmaceuticals, Genentech, Glaukos, jCyte Inc, Iveric Bio, Kriya Therapeutics, Kyowa Kirin, Inc, Lineage Cell, LumiThera, Inc, Nanoscope Therapeutics, NGM Biotherapeutics, Novartis Ophthalmics, Ocugen Inc, Ocular Therapeutix, Oculis SA, Ocuphire Pharma, OcuTerra Therapeutics, Ocutrx Vision Technologies, Opthea, Optigo Biotechnology, Optos, Oxurion NV, Palatin Technologies Inc, Pfizer, Regeneron Pharmaceuticals, RetinAI Medical AG, Ripple Therapeutics, Roche, Sanofi, Santen, Shenyang XingQi Pharma, Smilebiotek Zhuhai Limited, Stealth BioTherapeutics, Surrozen Inc, Syneos, Thea Laboratories, Unity Biotech, Vanotech Corp, Verseon Corp, Vitranu Inc, Vitro Biopharma, and Viva Vision Biotech (consultant and/or, speakers’ bureau); Allegro and DigiSight (Verana Health) (stock). Dr. Dayani: EyePoint Pharmaceuticals (speaker). J. Kasper is an employee of Alimera Sciences, Alpharetta, GA, USA. Dr. Rahhal: Alcon (consultant); BVI (advisor); ReVana Therapeutics, AivoCode, Outlook Therapeutics, Vantage Therapeutics, and Coherus (advisory board); and ExSight Ventures (equity). None of the other authors declared potential conflicts of interest with respect to the research, authorship, and/or publication of the article.

Figures

Figure 1.
Figure 1.
Best-corrected visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] letters). (A) BCVA at baseline compared with 24 months after fluocinolone acetonide (FAc) treatment (Tx). (B) Percentage of patient eyes with a BCVA of 70 ETDRS letters (Snellen equivalent 20/40) or more at baseline and at 24 months. (C) Mean BCVA from 12 months before FAc treatment to 24 months after based on available data by month.
Figure 2.
Figure 2.
(A) Mean central subfield thickness (CST) of eyes with a 24-month follow-up (n = 97) after fluocinolone acetonide (FAc) treatment. Significance was determined using the Student 2-tailed t test (P < .05). (B) Percentage of eyes with a CST of 300 μm or less 24 months after FAc treatment. Significance was determined by the Z test on normal distribution (P < .05). (C) Mean CST at baseline (month 0) and at each month after FAc treatment.
Figure 3.
Figure 3.
(A) Mean DME treatments per year 12 months before and 24 months after FAc treatment. (B) Percentage of eyes that were treatment free for DME management in the 12 months before and 24 months after FAc treatment. (C) Frequency distribution of eyes receiving DME treatments in the 12 months before and 24 months after FAc treatment. (D) Treatments per year by DME treatment class in the 12 months before and 24 months after FAc treatment. Significance was determined by the 2-tailed paired Student t test. Rate comparisons were completed using bootstrap analyses resampling at the subject level. Abbreviations: aVEGF, antivascular endothelial growth factor; DME, diabetic macular edema; FAc, fluocinolone acetonide.
Figure 4.
Figure 4.
Intraocular pressure (IOP) at baseline and after fluocinolone acetonide treatment for diabetic macular edema. (A) The mean IOP at baseline (month 0) and each month up to 24 months after fluocinolone acetonide treatment. (B) Kaplan-Meier curve of the likelihood of a spike in IOP of more than 25 mm Hg and more than 30 mm Hg.
See this image and copyright information in PMC

References

    1. Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010;376(9735):124-136. doi: 10.1016/S0140-6736(09)62124-3 - DOI - PubMed
    1. Rübsam A, Parikh S, Fort PE. Role of inflammation in diabetic retinopathy. Int J Mol Sci. 2018;19(4):942. doi: 10.3390/ijms19040942 - DOI - PMC - PubMed
    1. Funk M, Schmidinger G, Maar N, et al. Angiogenic and inflammatory markers in the intraocular fluid of eyes with diabetic macular edema and influence of therapy with bevacizumab. Retina. 2010;30(9):1412-1419. doi: 10.1097/IAE.0b013e3181e095c0 - DOI - PubMed
    1. Kiss S, Chandwani HS, Cole AL, Patel VD, Lunacsek OE, Dugel PU. Comorbidity and health care visit burden in working-age commercially insured patients with diabetic macular edema. Clin Ophthalmol. 2016;10:2443-2453. doi: 10.2147/OPTH.S114006 - DOI - PMC - PubMed
    1. Diabetic Retinopathy Clinical Research Network; Wells JA, Glassman AR, et al. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372(13):1193-1203. doi: 10.1056/NEJMoa1414264 - DOI - PMC - PubMed

LinkOut - more resources