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
Observational Study
. 2023 Dec;43(12):4639-4649.
doi: 10.1007/s10792-023-02864-2. Epub 2023 Sep 12.

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

José María Ruiz-Moreno  1   2   3 , Alfredo Adán  4 , María Lafuente  5 , Mónica Asencio Durán  6 , Luís Arias Barquet  7 , Alfredo García Layana  8 , Javier Araiz Iribarren  9
Affiliations
Observational Study

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

José María Ruiz-Moreno et al. Int Ophthalmol. 2023 Dec.

Abstract

Objective: To assess the effectiveness and safety of the intravitreal fluocinolone-acetonide implant (FAc-i) in patients with chronic diabetic macular edema who did not sufficiently respond to other available therapies.

Methods: This was a multicenter, prospective, non-randomized, and phase-IV observational study conducted on patients with recurrent-DME who were insufficient responders to currently available therapies (REACT-Study). The primary end-point was the mean change in best-corrected-visual-acuity from baseline to month-24 values.

Results: Thirty-one eyes from 31 patients were included in the study. Mean age was 68.0 ± 7.7 years, and 10 (32.3%) were women. Study patients had received 5.3 ± 7.3 previous DME treatments before starting the study. In the overall study sample, BCVA improved from 56.1 ± 12.3 letters at baseline to 62.4 ± 17.0 letters at month-24 (p = 0.0510). The eyes with a baseline BCVA < 70 ETDRS letters had a significant improvement in BCVA from 53.2 ± 10.2 letters at baseline to 61.5 ± 17.9 letters at month-24 (p = 0.0165). In the overall study population, central-subfoveal-thickness (CST) was significantly reduced from 474.0 ± 135.1 µm at baseline to 333.4 ± 135.6 at month-24 (p < 0.0001). Similarly, macular-volume (MV) was significantly reduced from 10.7 ± 2.7 mm3 at baseline to 9.6 ± 2.9 mm3 (p = 0.0027) at month-24. Among the 31 study eyes, 19 (61.3%) required an additional treatment for DME. Throughout the study, 9 (29.0%) eyes required ocular hypotensive medication for controlling their intraocular-pressure and 5 (16.1%) eyes underwent cataract surgery.

Conclusions: In DME eyes who did not sufficiently respond to previous therapies, the FAc-i was associated with an improvement in visual and anatomic outcomes. There were no unexpected adverse-events.

Trial registration number: EudraCT identifier: 2016-001680-37.

Keywords: Corticoids; Diabetic macular edema; Fluocinolone acetonide intravitreal implant; VEGF inhibitors.

PubMed Disclaimer

Conflict of interest statement

Dr Ruiz-Moreno has received a Grant from Alimera during the conduct of the study. Neither honoraria nor payments were made for authorship of this article. The other authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.

Figures

Fig. 1
Fig. 1
Mean best corrected visual acuity throughout study follow-up in the overall study population (A) and in the eyes with a baseline BCVA < 70 ETDRS letters (B). Statistically significance was calculated by using paired sample two-tailed t test or Wilcoxon test, as appropriate. BCVA Best corrected visual acuity; ETDRS Early Treatment Diabetic Retinopathy Study; ns Not significant; W Week; M Month
Fig. 2
Fig. 2
A comparison of the mean best corrected visual acuity (BCVA) throughout study follow-up in the eyes with a baseline BCVA < 50 ETDRS letters (8 eyes; dotted line) and those with a baseline BCVA ≥ 50 ETDRS letters (23 eyes; solid line).Statistically significance was calculated by using independent sample t test. BCVA Best corrected visual acuity; ETDRS Early Treatment Diabetic Retinopathy Study; ns Not significant; W Week; M Month
Fig. 3
Fig. 3
Mean central subfoveal thickness CST (A) and macular volume (MV) (B) throughout study follow-up in the overall study population. Statistically significance was calculated by using the two-tailed paired sample t test. CST Central subfoveal thickness; MV Macular volume; W Week; M Month
See this image and copyright information in PMC

References

    1. Im JHB, Jin YP, Chow R, Yan P. Prevalence of diabetic macular edema based on optical coherence tomography in people with diabetes: a systematic review and meta-analysis. Surv Ophthalmol. 2022;67(4):1244–1251. doi: 10.1016/j.survophthal.2022.01.009. - DOI - PubMed
    1. Schmidt-Erfurth U, Garcia-Arumi J, Bandello F, Berg K, Chakravarthy U, Gerendas BS, et al. Guidelines for the management of diabetic macular edema by the European society of retina specialists (EURETINA) Ophthalmologica. 2017;237(4):185–222. doi: 10.1159/000458539. - DOI - PubMed
    1. Ruiz-Medrano J, Rodríguez-Leor R, Almazán E, Lugo F, Casado-Lopez E, Arias L, Ruiz-Moreno JM. Results of dexamethasone intravitreal implant (Ozurdex) in diabetic macular edema patients: early versus late switch. Eur J Ophthalmol. 2021;31(3):1135–1145. doi: 10.1177/1120672120929960. - DOI - PubMed
    1. Alessio G, Boscia F, Caporossi A, Panozzo G, Reibaldi M, Staurenghi G, Varano M, Bandello F. Dexamethasone implants in patients with diabetic macular edema undergoing cataract surgery: Italian expert panel consensus statements. Eur J Ophthalmol. 2021;31(3):1122–1127. doi: 10.1177/1120672120939500. - DOI - PubMed
    1. Campochiaro PA, Nguyen QD, Hafiz G, Bloom S, Brown DM, Busquets M, Ciulla T, Feiner L, Sabates N, Billman K, Kapik B, Green K, Kane FE, FAMOUS Study Group Aqueous levels of fluocinolone acetonide after administration of fluocinolone acetonide inserts or fluocinolone acetonide implants. Ophthalmology. 2013;120(3):583–587. doi: 10.1016/j.ophtha.2012.09.014. - DOI - PubMed

Publication types