Purchase this article with an account.
P. Pearson, C.W. Baker, D. Eliott, M.S. Ip, L.S. Morse, D. Callanan; Fluocinolone Acetonide Intravitreal Implant in Patients with Diabetic Macular Edema: 12 Month Results . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4288.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Purpose: A multicenter, randomized, controlled clinical trial is being conducted to investigate the use of a sustained release fluocinolone acetonide intravitreal implant in patients with diabetic macular edema. Methods: Eighty patients with a history of macular laser photocoagulation and refractory or recurrent diabetic macular edema were randomized into one of three study groups: 2mg implant dose group (n = 11), 0.5mg implant dose group (n = 41), and standard of care (SOC) group (n = 28). Standard of care treatment consisted of either macular grid laser or observation. Results: At 6 months, macular edema improved significantly in the 0.5mg implant group as compared to patients treated with standard of care (p<0.05). This improvement was further maintained at 12 months (p<0.01). The overall incidence of serious ocular adverse events at 12 months was 21.4% (6/28) in the SOC group and 43.9% (18/41) in the 0.5mg implant group. These serious adverse events included cataract development, 24.4% (10/41) in the 0.5mg implant group compared to 3.5% (1/28) in the SOC group and intraocular pressure rise (including glaucoma), 12.2% (5/41) in the 0.5mg implant group compared to 0% (0/28) in the SOC group. Conclusion: Treatment with a sustained release fluocinolone acetonide implant appears safe and effective in the studied patient population at 12 months. Dr. Pearson acknowledges a financial interest in the subject matter of this presentation.
This PDF is available to Subscribers Only