The following is a summary of “Real-World Evidence of the Long-Term Effectiveness of 0.2 μg/Day Fluocinolone Acetonide Implant in Persistent and Recurrent Diabetic Macular Edema – A Single Center Study,” published in the April 2024 issue of Ophthalmology by Soares et al.
Researchers conducted a retrospective study to present the long-term functional, anatomical, and safety outcomes of administering 0.2 μg/day of fluocinolone acetonide 0.19mg to patients experiencing persistent or recurrent diabetic macular edema (DME).
They performed a study on patients with persistent or recurrent DME, all treated with 0.2µg/day of fluocinolone acetonide 0.19mg. They collected data at baseline and follow-up visits over 36 months at multiple intervals after implantation, measuring outcomes like best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP), and safety.
The results showed 28 patients with a mean age of 66.5 years (95% CI 62.8-70.2) and a mean duration of DME of 8.8 years (95% CI 7.7-10.0). Only two eyes were phakic. Follow-up averaged 25.4 months (95% CI 21.2 – 29.6). Visual acuity improved significantly over time, starting month one onwards, with a BVCA of 7.8 (95% CI 4.3-11.3) ETDRS letters (P<0.001), with the most significant improvement observed at months 6, 12, and 24. Patients with mean CMT of 530.5µm (95% CI 463.0-598.0), and a decrease in CMT was observed, starting at the first month of follow-up (mean CMT reduction of -170.5µm, 95%CI -223.8 – -117.1, P<0.001). Significant decreases in macular thickness were observed at months 6, 12, 24, and 36, with the most significant decrease observed at month 12 (P<0.001). Mean IOP at baseline was 16.4mmHg, and nine eyes (32.1) had increased intraocular pressure (≥21mmHg) during follow-up.
Investigators concluded that fluocinolone acetonide is effective and safe, offering benefits for DME treatment.
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