Session Title: Vascular Diseases and Diabetic Retinopathy III
Session Date/Time: Saturday 19/09/2015 | 16:30-18:00
Paper Time: 17:18
First Author: : A.Manna UNITED KINGDOM
Co Author(s): : N. Dhillon S. Patra R. Vemala M. Tsaloumas
PURPOSE:Chronic DME can be difficult to manage with current standard therapies, such as anti-VEGF injections and laser. Based on results from the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) studies (NCT00344968), fluocinolone acetonide [FAc, ILUVIEN®] 0.19 mg implant is approved for DME insufficiently responsive to available therapies. This multicentre case series evaluates outcomes following a single FAc 0.19 mg implant in patients with chronic DME insufficiently responsive to all other modes of therapy.
Intravitreal FAc 0.19 mg implant provides a sustained, low-dose release of fluocinolone acetonide of 0.2 μg/day for up to 36 months. This case series focuses on the long-term efficacy and safety of FAc 0.19 mg implant (up to 12 months) in difficult-to-treat patients.
Patients were receiving care in one of two centres in the UK (Birmingham and London). A total of 33 eyes of 30 patients (n=16 females; n=14 males; 42–85 years), with predominantly with type-2 diabetes (n=26, T2DM; n=5, T1DM) and chronic DME, were followed for up to 12 months following a single FAc 0.19 mg implant. Three patients had bilateral treatment. The majority of eyes had received prior anti-VEGF therapy (n=21), intravitreal steroid injections (n=21), or laser photocoagulation (n=17), either alone or in combination. Eighteen of the treated eyes had documented DME for 3 or more years. Examinations were performed at baseline and 1 week, 6 weeks, 3-4 months, 6 months, and 12 months following treatment with FAc 0.19 mg implant. LogMAR visual acuity (VA), central subfield thickness (CST), and intraocular pressure (IOP) were assessed, along with qualitative changes in retinal morphology. Data was collected retrospectively and pooled from both sites. Slightly different datasets were collected at each centre.
The mean baseline logMAR VA was 0.64; mean improvement in logMAR VA was 0.05. Four of 33 eyes had less than 6/60 Snellen acuity at final follow-up and 5 of 33 eyes had 6/12 or better Snellen acuity at final follow-up. The mean baseline CST for all eyes was 464 microns and the mean reduction in CST at final follow-up was 102 microns. The 13 eyes treated in the London centre also showed a mean reduction in average macular thickness of 24.5 microns but no change in mean macular volume. Almost half the eyes treated in both centres were ‘dry’ at the final follow-up visit. Patients had minimal change in IOP, and only 3 required IOP lowering drops. No patient required glaucoma surgery. Of the eyes treated in the Birmingham centre there were 4 cases of non-response to FAc 0.19 mg implant (1 case within 2 months and 3 after 10 months). All 4 patients were given further intravitreal treatment (ranibizumab for 3 patients and triamcinolone for 1).
Sustained-release FAc 0.19 mg implant appears to provide clinical benefit in patients with chronic DME insufficiently responsive to existing therapies. In this group of patients, DME management was a clinical challenge due to the lack of response to first-line therapies. Treatment with FAc 0.19 mg implant showed promising results in these challenging patients, with manageable IOP side effects.