Introduction
To determine anatomical, functional, and intraocular pressure (IOP) responses to diabetic macular edema (DME) treatments pre- and post-0.2 µg/day fluocinolone acetonide (FAc) implant administration compared with baseline and the preceding 3 years.
Methods
This was a retrospective, chart review, cohort study in four U.S. centers. Patients received the 0.2 µg/day FAc implant for the treatment of DME in at least one eye before January 1, 2016. DME treatments administered up to 36 months pre-FAc implant and up to 24 months post-FAc implant were recorded, and treatment frequency was calculated. Visual acuity (VA) was assessed using a Snellen eye chart and converted to early treatment diabetic retinopathy study (ETDRS) letters, and central subfield thickness (CST) was measured using optical coherence tomography (OCT). Treatment frequency, mean VA, mean CST, percentage of patients with CST of ≤ 300 µm, mean IOP, IOP events, and IOP treatments pre- and post-FAc implant administration were measured. Positive and negative predictive values for the IOP response to prior steroid therapy were also determined.
Results
In total, 160 eyes of 130 patients were studied. VA was maintained at pre-FAc levels from baseline to month 24, despite a significant reduction in treatment frequency from one treatment every 2.9 months pre-FAc implant to one treatment every 14.3 months post-FAc implant. Patients with better baseline VA required fewer DME treatments post-FAc than did patients with worse baseline VA. The majority of patients did not require additional DME treatment during the post-FAc follow-up period. A significant reduction in CST and an increase in the percentage of patients with CST of ≤ 300 µm were seen up to month 21 post-FAc implant. Pre-FAc implant IOP was maintained during the post-FAc implant period; increased IOP with prior steroid therapy was found to be highly predictive of increased IOP post-FAc implant.
Conclusion
The results of this study confirm the positive safety and efficacy profile of the FAc implant and demonstrate for the first time the effectiveness of the U.S. label indication of FAc in reducing the incidence of post-treatment pressure elevation. The FAc implant significantly reduced treatment burden in the overall population without significantly increasing the risk of steroid-induced pressure elevation.
Funding
Alimera Sciences.
A statistically significant increase in the rate of sterile endophthalmitis after intravitreal triamcinolone acetonide was seen in a 6 month period in 2006 when compared with the same period in 2005. Transition to preservative-free triamcinolone acetonide produced a frequency of sterile endophthalmitis similar to 2005.
A dog developed signs of neurological dysfunction five days after rapid correction of severe electrolyte derangements, including hyponatremia, caused by gastrointestinal parasitism (i.e., trichuriasis). History, laboratory findings, and onset of neurological signs following correction of hyponatremia led to a diagnosis of myelinolysis. Myelinolysis is a noninflammatory, demyelinating brain disease caused by sudden, upward osmotic shifts in central nervous system plasma, often a result of rapid correction of chronic hyponatremia. The pathogenesis is complex, but recovery is possible. Iatrogenic damage due to myelinolysis can be avoided by adherence to therapeutic guidelines for correction of chronic hyponatremia.
Purpose To assess the ability of a novel imaging device to allow physicians to personalize therapeutic regimens based on objective patient drop administration data. Methods A novel imaging system was used to record video of the drop technique of subjects in clinic (n = 25) or at home (n = 17) for 1 week. Video assessment by a reading center was compared with patient reporting and their prescribed regimen with respect to how many drops were applied and how many landed in the eye. Results Reading center assessment of both drops dispensed and drops landing in the eye was significantly different from the prescribed regimen in the clinic (P d = 0.005, P i o0.001, respectively) and at-home arms (P d = 0.003, P i o0.001, respectively). Conclusions This imaging system is a powerful tool to help physicians tailor patient therapy more accurately, to help researchers evaluate new drop therapies with objective rather than subjective data, and to potentially facilitate better patient training for improved drug delivery.
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