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FAME: Steroid implant an efficacious treatment option for diabetic macular edema
Campochiaro PA. Ophthalmology. 2011;118(4):626-635.
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Twenty-four month results for two phase 3 clinical trials suggested that low- and high-dose fluocinolone acetonide implants may be efficacious in treating diabetic macular edema, with the low-dose implant offering a superior risk-to-benefit ratio.
“The 0.2- and 0.5-mcg/day inserts showed no significant difference in efficacy outcomes, but significantly fewer incisional glaucoma procedures were needed in the low-dose insert group," the study researchers wrote.
The trials, known collectively as the FAME (Fluocinolone Acetonide in Diabetic Macular Edema) study, are 36-month parallel, prospective, randomized, double-masked, multicenter trials conducted in the US, Canada, Europe and India assessing sustained-release fluocinolone acetonide (Iluvien, Alimera Sciences).
All study participants had persistent diabetic macular edema despite at least one macular laser treatment. Sham injections were given to 185 participants, while 375 participants were treated with low-dose inserts and 393 were treated with high-dose inserts.
At 24 months’ follow-up, mean best corrected visual acuity improvements for the low- and high-dose groups were 4.4 and 5.4 letters, respectively, compared with 1.7 letters for the sham group.
Cataract and glaucoma surgery were more prevalent for the implant groups; however, glaucoma requiring incisional surgery occurred in 3.7% of patients in the low-dose group, compared with 7.6% in the high-dose group.
Disclosure: The research was supported by Alimera Sciences, Inc. and Psivida, Inc. The researchers reported various disclosures; for a full list, visit the study abstract link.
The FAME study investigators assessed an appealing option — sustained drug delivery, in this case, with fluocinolone acetonide. This approach addresses the treatment burden of monthly intravitreal injections, as it allows for fewer injections and, if monthly pressure monitoring is not needed, fewer office visits. Due to cataract development, subgroup outcomes in the study varied. Phakic patients at 2 years had higher visual acuity if they were in the sham group, while patients who were pseudophakic at baseline did better in either of the steroid treatment groups. For me, the appeal of the FAME study approach will relate to lens status, long-term outcomes after cataract surgery and eye pressure issues. Having more treatment options is preferred, and I am glad to add options to or even possibly replace laser if that means providing better outcomes for patients.
– Andrew P. Schachat, MD
Vice Chairman,
Cole Eye Institute, Professor of Ophthalmology
Lerner College of Medicine
Disclosure: Dr. Schachat reports no relevant financial disclosures.
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