First Author: U.Mulla UK
Co Author(s): S. Rajesekaran S. Drummond M. Varikkara K. Wong W. Wykes
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In the FAME studies, DME patients who had been previously been treated with laser photocoagulation were included. Currently, patients are being treated with fluocinolone acetonide (FAc) implant in the clinical setting after having been exposed to a wide spectrum of alternative DME herapies. These include anti-VEGF agents and corticosteroids. This observational study aims to assess patients’ response to and safety of FAc implant in patients whose diabetic macular edema (DME) had a suboptimal response to prior alternative treatments.
A retrospective observational case review from three Scottish Health Boards from the time period of August 2014 to October 2016. 21 patients and 26 eyes (16 patients treated unilaterally and 5 treated bilaterally) with DME treated with a single FAc implant per eye were identified and included in the study.
Visual acuity (VA, converted to ETDRS letters), central retinal thickness (CRT; measured using OCT) and intraocular pressure (IOP) were reviewed and analyzed. Data pre-injection of FAc implant (i.e. baseline) and subsequent post- injection data at 4 weeks and at every 3 months were collected, reviewed and analyzed. Values were then plotted as means ± SEM.
The mean age of the patients was 67 years. 67% were female and 33% male. The mean duration of DME was 51.9±6.9 months. Average follow up is 8.8±1.25 months. 21 eyes were pseudophakic, 5 eyes were phakic (3 had cataract surgery at the time of FAc injection, 1 required cataract removal after FAc treatment). 2 patients had had previous vitrectomy. At baseline, the mean VA was 46.8 ± 3.7 letters, the mean CRT was 448.2 ± 28.2 µm and the mean IOP was 16.0 ± 0.7 mmHg. Patients had been treated with a mean of 5.1 ± 0.6 injections of anti-VEGF agents and 1.7 ± 0.2 injections of corticosteroids prior to intravitreal injection of the FAc implant. At month 12 the mean change in VA was 11.9±4.1 letters (p=0.0129), mean change in CMT was -159.0 ± 38.6 µm (p=0.0012), with no statistically significant change in IOP. 44% of patients gained ≥ 15 letters, with 88% demonstrating improvement in VA. Only 4% of patients demonstrated deterioration in vision.
Despite a long duration of DME and prior treatments with both anti-VEGF and corticosteroid injections, the eyes in this study showed a rapid reduction in edema and significant gains in vision (46.8 ± 3.7 letters), sustained throughout 12 months, with minimal change in intraocular pressure and 1 out of 5 phakic eyes required cataract extraction. Therefore, this study supports the safe and efficacious use of fluocinolone acetone implant as a second line agent with good visual acuity and CRT outcomes in chronic macular oedema where response to previous alternative therapies were suboptimal.