An analysis of data from the FAME trials was undertaken to try to understand the final three-year visual and anatomic outcomes of patients treated with the fluocinolone acetonide intravitreal implant (Iluvien, Alimera Sciences) who exhibited suboptimal early responses, as measured at six weeks after the initial injection.
A unique characteristic about patients in the FAME trials is that they were able to receive additional therapies throughout and still be included in the final data analysis, said Daniel F. Kiernan, MD, of Ophthalmic Consultants of Long Island, New York.
Therefore, the data may reflect more of a real-life experience in situations such as deciding when to re-treat after seeing persistent fluid or a decrease in vision. This analysis may assist in treatment decisions, if positive conversion is seen over time.
For this study, two groups of patients were identified from the FAME study data as having suboptimal response at six weeks. These patients had received the 2.0 microgram implant. The first group was chosen based on anatomic response, including patients whose reduction in central subfield thickness was less than 50 microns at six weeks, and the second group was chosen based on visual response, including those with an improvement in best-corrected visual acuity (BCVA) of less than 5 letters at six weeks.