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Treating Diabetic Macular Edema with an Implant

The prevalence of macular edema, the primary cause of impaired vision in diabetic patients, is on the rise….

Current therapy for diabetic macular edema (DME) is focal or grid photocoagulation. Surgical techniques have also had some success. Based on the knowledge that vascular endothelial growth factor (VEGF) plays a role in increased vascular permeability associated with DME, the first pharmacological treatment, the anti-VEGF antibody ranibizumab, was approved in 2012 for treatment of DME. However, further studies showed that more than 50% of ranibizumab treated eyes did not achieve a visual acuity improvement form baseline of 10 letters or more at year 2.

A study was then done to present the safety and efficacy of intravitreal implants releasing 0.2mcg/day of fluocinolone acetonide (FAc) in patients which chronic versus nonchronic DME. Chronic was defined as a diagnoses of DME for 3 years or greater while a diagnoses if DME for less than 3 years was characterized as nonchronic.

The FAME A and B studies were performed under a single protocol as a 36 month, randomized, double-masked, sham-injection-controlled, parallel-group, multicenter study. Enrolled patients had a time-domain optical coherence tomography foveal thickness of at least 250 micrometers despite at least 1 previous focal or grid macular laser photocoagulation treatment. Patients with glaucoma, ocular hypertension, or intraocular pressure of more than 21mmHg or those receiving medications to lower intraocular pressure were excluded.

A total of 956 patients were randomized 2:2:1 to receive FAc 0.2 mcg/day intravitreal implant, FAc 0.5 mcg/day intravitreal implant or sham injection in 1 eye. The primary outcome of the study was percentage of patients with improvement of 15 letters or more from baseline.

At month 36, the difference between the group that received FAc 0.2mcg/day who reached the goal of 15 letters or more was significantly greater in chronic DME patients compared with patients who had nonchronic DME. This study showed that FAc implants can provide a substantial visual benefit for up to 3 years for patients who have experienced visual impairment.

Practice Pearls:

  • The prevalence of macular edema, the primary cause of impaired vision in diabetic patients, is on the rise.
  • At month 36, the difference between the group that received FAc 0.2mcg/day who reached the goal of 15 letters or more was significantly greater in chronic DME patients compared with patients who had nonchronic DME.

Cunha-Vaz MD, Jose, Ashton PhD, Paul, Iezza MD, Raymond, et al. Sustained Delivery Fluocinolone Acetonide Vitreous Implants: Long-Term Benefit in Patients with Chronic Diabetic Macular Edema. Aaojournal. June 13, 2014.