Author: João Ramalhão (Portugal)
Co-authors: João Leite, André Ferreira, João Coelho, Tânia Borges, Nuno Correia, Bernardete Pessoa
Treatment of Diabetic Macular Edema (DME) with intravitreal (IV) injections can be associated with a high appointment burden for patients, which has the potential to affect patient’s quality of life in a multitude of ways. The IV implant of fluocinolone acetonide (FAc, 0.19 mg, ILUVIEN®) is an injectable corticosteroid implant approved for the treatment of diabetic macular edema (DME), with continuous and sustained release of FAc for up to 3 years. The aim of this study was to evaluate the effectiveness of ILUVIEN®, comparing the 24 months after treatment with FAc implant with the previous 24 months, in patients with persistent and recurrent DME.
This study compares the response to treatment, 2 years before and 2 years after the injection of the FAc implant, in patients with diabetic macular edema, carried out at Centro Hospitalar e Universitário do Porto, Portugal.
Retrospective and observational study which included 45 eyes from 33 patients with DME that persisted or recurred despite treatment. All patients received an injection of FAc implant between April 2015 and June 2017. Different ophthalmic parameters were measured for 24 months after the FAc implant compared to the same pre-FAc period: best corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP) and number of IV and / or laser treatments performed. After FAc implant, the variation of BCVA, CMT and IOP was evaluated at month 1, 3 and then quarterly until the end of follow-up.
The mean age of patients was 69.6 ± 8.4 years. Before the FAc implantation, 93.3% underwent panretinal photocoagulation and 28.9% macular LASER. The average number of IV treatments in the 24 months prior to ILUVIEN® was 6.8 (4.3 anti-VEGF and 2.5 short-acting steroids). At the moment of the FAc implant injection, 42.2% of the eyes were medicated with hypotensive drops (IOP 15.6 ± 2.9 mmHg), BCVA was 42.1 ± 18.4 ETDRS letters and CMT was 538.4 ± 190.0 µm. After a 2-year follow-up, 51.1% of the eyes were medicated for IOP (16.4 ± 4.0 mmHg) (p<0.001), BCVA was 52.9 ± 21.7 ETDRS letters (p=0.000) and CMT was 381 ± 239.2 µm (p=0.000) [greater reduction in eyes without need of additional treatment during follow-up (p> 0.05)]. After FAc implant, 24 eyes required additional treatment, on average, 283.8 ± 188.3 days after FAc: 10 eyes (22.2%) underwent laser therapy, 17 eyes (37.7%) received anti-VEGF and 4 eyes (8.8%) received short-acting steroids. The average number of IV treatments in the 24 months after FAc implant was 2.6 treatments (2.5 anti-VEGF, 0.1 short-acting steroids) (p=0.002). In 3 eyes, an additional FAc implant was required, on average 491 ± 111.3 days after the first one.
This study shows that the injection of the FAc implant has great efficacy in the treatment of recurrent and persistent DME, evidenced by the significant improvement in the increase in the BCVA, a high reduction in the CMT, without significant variations in the IOP during the follow-up. It also shows that this therapy leads to a significant reduction in the burden of treatment with clear benefit for the patients. Although there was a need for additional treatment in some eyes, there was a considerable decrease in the number of treatments per eye (6.8 pre-FAc vs 2.6 post-FAc) and in almost 50% of the eyes, no additional treatment was needed during the 24 months of treatment follow-up.