Fluocinolone acetonide implant effective in treating diabetic macular edema: BMJ
USA: The use of the 0.2 ug/day fluocinolone acetonide (FAc) implant is beneficial for the management of diabetic macular edema, a recent study in the British Journal of Ophthalmology has found. According to the study, following 24 months of FAc implant, there were few intraocular pressure (IOP)-related procedures. Also, there was a stabilization of vision and reduction in inflammation.
Approximately 35% of the diabetes patients develop diabetic retinopathy and 7% progress to diabetic macular edema (DMO) which a severe vision-threatening stage of diabetic retinopathy. The FAc implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular edema.
Sam E Mansour, George Washington University, Washington, District of Columbia, USA, and colleagues conducted this his 24-month interim analysis of a prospective, observational study to investigate patients with DMO receiving the commercially available intravitreal 0.2 µg/day FAc implant. Data were collected from 95 previously steroid-challenged patients (115 study eyes) for up to 36 months pre-FAc and 24 months post-FAc implant.
The primary outcome was incidence of intraocular pressure (IOP)-lowering procedures.
Key findings of the study include:
- 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 and the percentage of patients with CST ≤300 µm was significantly increased.
"Few IOP-related procedures were reported during the 24 months post-FAc implant. Positive efficacy outcomes were noted after treatment, with stabilization of vision and reduction in inflammation, demonstrated by CST. The FAc implant has a favorable benefit-risk profile in the management of DMO, especially when administered after a prior steroid challenge," concluded the authors.
"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," is published in the British Journal of Ophthalmology.