Abstract
Purpose:
The FAME trials demonstrated that 0.2 μg/d fluocinolone acetonide (FAc) intravitreal implants significantly improved BCVA and reduced retinal thickness over 36 months in patients with DME. The FAMOUS pharmacokinetic study showed that a single implant could deliver a submicrogram dose of FAc over 36 months; at study end, measurable levels of FAc were still present in human aqueous and were similar to levels at month 24. The FAME Extension Study was conducted to assess the safety and utility of a new injector for the administration of the 0.2 μg/day FAc implant. A portion of patients enrolled in the FAME Extension Study previously participated in FAME. The present report characterizes patients participating in both the FAME and FAME Extension Studies.
Methods:
This open-label study enrolled patients with DME who previously participated in the phase 3 FAME trials. All enrolled patients (n = 64) received a single 0.2 μg/d FAc treatment in the same eye treated during FAME.
Results:
Patients were on average 68 years old (mean DME duration = 7.32 years). Prior treatment in FAME was fairly evenly split, with 23.4%, 34.4%, and 42.2% receiving sham, 0.2 μg/d FAc, and 0.5 μg/d FAc, respectively. Mean time elapsed between exiting FAME and receiving a treatment in the study was 585 days. The mean BCVA for these 64 patients entering the FAME Extension Study was 62.7 ETDRS letters. After 12 months, BCVA showed a modest gain of approximately 2 letters (mean BCVA at month 12 = 64.5 ETDRS letters) and improved retinal anatomy from a baseline of 316.6 μm to 261.0 μm. In general, 0.2 μg/d FAc was well-tolerated. AEs were consistent with the class: mean IOP increased by approximately 2.5 mm Hg; four patients developed ocular hypertension, and cataract and IOP-lowering surgeries were performed on one patient each.
Conclusions:
The FAME Extension Study included a cohort of patients who previously participated in FAME. There was an average time lag of 1.6 years between FAME study end and participation in the FAME Extension Study. In the FAME Extension Study, on average, BCVA was maintained and retinal anatomy improved. Individual patient data will provide details on the spectrum of response. The safety profile was consistent with the class and supports the use of 0.2 μg/d FAc implants for the treatment of DME.