Abstract
Purpose: :
To describe the effects of Iluvien® (fluocinolone acetonide [FAc] intravitreal insert) on intraocular pressure (IOP) and related events.
Methods: :
The FAME studies enrolled 956 subjects with diabetic macular edema (DME) with retinal thickness ≥250 microns and IOP < 21 mmHg in a 2:2:1 (0.2 µg/day, 0.5 µg/day, sham) ratio. Special care was taken to assess the effects on the IOP. At each visit, IOP was measured by Goldmann applanation tonometry and IOP-related medications and adverse events were documented. Investigators determined the cup/disk ratio for all subjects. In addition, the Reading Center determined the cup/disk ratio from fundus photographs for patients with an IOP >25 mmHg on two occasions during the first 6 months of the study and for age-, gender-, race- and baseline IOP-matched controls selected from the FAME patients who did not experience such IOP elevations.
Results: :
At baseline, mean IOP measurements were similar among the groups (15.0-15.2 mmHg). Mean increases from baseline of between 2-3 mmHg for the 0.2 µg/day group and 2-4 mmHg for the 0.5 µg/day group were observed from baseline through Month 24. Subjects in the sham group required fewer IOP-lowering medications (14%, sham; 34%, 0.2 µg/day FAc; 44%, 0.5 µg/day FAc). Based on time to first use of IOP-lowering medication most of these subjects were treated for the first time by Month 12. The incidence of any surgical intervention (i.e., trabeculectomy, glaucoma surgery, or vitrectomy for elevated IOP) was lower in the sham group than the active groups (1%, sham; 4%, 0.2 µg/day FAc; 7%, 0.5 µg/day FAc). The most common IOP-related procedure in the study eye was trabeculectomy (3%). Less than 2% of all subjects underwent other IOP lowering surgeries. The majority of IOP-related procedures occurred between Months 12 and 24.
Conclusions: :
The FAME studies demonstrate that, although IOP is elevated in 1/3 of subjects treated with low dose Iluvien, nearly all of these subjects are adequately treated by IOP lowering medications or surgery. There were no significant changes in the cup/disk ratio in patients who experienced IOP >25 mmHg on 2 occasions during the first 6 months of the study. The ocular hypertensive effect of FAc inserts is a manageable side effect.
Clinical Trial: :
http://www.clinicaltrials.gov NCT 00344968
Keywords: diabetic retinopathy • edema • drug toxicity/drug effects