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| |  Intraocular Implant Beneficial in Treating Diabetic Macular Oedema: Presented at RC2009 By Cameron Johnston NEW YORK -- October 7, 2009 -- An intraocular implant that delivers microscopic doses of fluocinolone acetonide to the posterior pole can produce significant improvements in a number of parameters that measure diabetic macular oedema (DME) lasting from 2 years to 30 months. The implant is approximately the size of a grain of rice and is inserted into the vitreous where the active drug is delivered at approximately 0.4 to 0.6 mcg per day. In a study presented here on October 3 at the Retina Congress (RC) 2009, Dean Eliott, MD, Doheney Eye Center, Los Angeles, California, discussed the results of a multicentre, 4-year study in which the insert was used in patients with DME. Dr. Elliott and colleagues recruited 196 patients, of whom 130 received the implant while the remainder underwent macular laser treatments (standard of care). In prior studies of patients with uveitis, the effect of the implant wore off dramatically after 30 months, and this study was largely the same. The resolution in macular oedema as graded on masked fundus photos, and retinal thickness were each significantly greater than with usual care at the 1-year and 2-year timepoints, whereas the results for years 3 and 4 were more or less similar in each arm. In addition, the percentage of patients having a 1-step improvement on the diabetic retinopathy severity score was significantly greater than standard of care at 1 year, but this advantage tapered off and became less robust in years 2 and 3. More eyes receiving the implant had a >=2 grade improvement in the amount of leakage seen on fluorescein angiography compared with the usual-care arm at 6, 12, and 24 months. On the cystoids score, more eyes in the study arm showed an improvement of >=1 grade compared with the usual-care arm at months 3 and 6. More patients receiving the implant experienced an improvement in visual acuity of at least 3 lines compared with the usual-care arm, but there was no difference in the percentage of patients experiencing a 3-line decrease in visual acuity. The insert was not without its adverse side effects. Ninety-one percent of all phakic eyes had to undergo cataract extraction between months 12 and 18, compared with 19% of phakic eyes in the standard-of-care group. Furthermore, 61% of study eyes developed elevated intraocular pressure that soared to >=30 mmHg at any time. One-third of patients required filtering surgery and 2% required explantation of the insert because their intraocular pressure rose so high. Dr. Eliott commented that despite the side effects, the implant is beneficial in treating DME. The loss of efficacy after approximately 30 months is due to drug depletion in the implant, he said, but there is no reason why a further implant could not be inserted once the original implants loses a crucial level of efficacy. [Presentation title: Results of a 4-Year Multicenter Clinical Trial of the Fluocinolone Acetonide Intravitreal Implant to Treat Diabetic Macular Edema]
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