Better Treatments for Diabetic Macular Edema

Charles C. Wykoff, MD, PhD


September 27, 2013

In This Article

Steroids in Diabetic Macular Edema

Corticosteroids are prescribed for several medical indications. In the eye, corticosteroids are often used to suppress inflammation, and 2 major clinical trials have assessed their efficacy for managing diabetic macular edema.[16] In both trials, steroids were beneficial, but also associated with the significant side effects of cataract progression and risk for increased intraocular pressure.

The DRCR Protocol I evaluated the roles of intravitreal triamcinolone acetonide or ranibizumab in addition to focal laser treatment in 854 eyes with diabetic macular edema. In the pooled analysis, ranibizumab was superior to triamcinolone at the 1-year primary endpoint, and again at 2 years.[15,17] A subgroup analysis of eyes that had undergone cataract surgery (pseudophakic eyes), however, revealed similar efficacy for triamcinolone and ranibizumab.

A long-acting steroid implant has also been developed and tested in patients with diabetic macular edema. This fluocinolone acetonide implant is administered in the clinic using a 25-gauge inserter, and it leads to sustained drug release for up to 36 months (Iluvien™, Alimera Sciences Inc., Alpharetta, Georgia).[18] The FAME randomized, sham-controlled trials assessed the efficacy and safety of this implant in patients with persistent diabetic macular edema despite previous focal laser treatment. At 36 months, 27.8%-28.7% of implant-treated eyes vs 18.9% of sham eyes demonstrated an improvement of 15 or more letters (P = .018). A subgroup analysis showed particular benefit among patients with diabetic macular edema for 3 or more years. The side effects were significant among steroid-treated eyes; up to 8.1% required incisional glaucoma surgery, and cataracts progressed in nearly all phakic eyes.

On the basis of the results of the FAME studies, the fluocinolone acetonide implant has been approved in Europe for the treatment of diabetic macular edema-related visual impairment that is considered insufficiently responsive to available therapies. This sustained delivery implant remains under consideration by the FDA in the United States.


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