Diabetes mellitus is a chronic metabolic disease whereby blood glucose is poorly regulated, causing increased levels of blood glucose over a prolonged period. Hyperglycemia leads to long-term damage, dysfunction, and failure of several organs. Diabetes includes macrovascul ar and microvascular complications. Diabetic Retinopathy (DR) is a chronic microvascular complication and is the world’s leading cause of preventable blindness among working-age adults. Current therapies to treat DR include laser pan-retinal photocoagulation (PRP), intravitreal injection of anti-VEGFs, corticosteroids and surgery. While for many patients anti-angiogenic therapy offers good outcomes, approximately 50% of the patients do not respond sufficiently and recurrence of DME is often. Moreover, the majority of the drugs injected into the eye to treat DME has a short duration and it is required multiple injections to maintain the outcomes obtained initially with treatment. This causes a significant burden for the patient, for caregivers, physicians, and for the healthcare system. Fluocinolone acetonide (FAc) is a long-term continuous microdosing delivery system engineered to suppress inflammatory responses of a variety of inciting agents including multiple inflammatory cytok ines and treat DME up to 3 years with a single intravitreal injection. The aim of this study was to assess effectiveness and safety of FAc implant in a real-life setting and compare the results obtained with clinical trials outcomes.


This is a single center, retrospective study of 19 eyes from 15 chronic DME patients treated with FAc after a previous insufficient response to anti-VEGF intravitreal injections. Visual acuity (VA), central macular thickness (CMT), macular volume (MV) and intraocular pressure (IOP) were evaluated at baseline, month 1 and then quarterly until month 18.


Mean age of patients was 68.6 ± 9.6 years (mean ± standard deviation). 47.4% male and 52.6% female. 47.4% were phakic and 52.6% pseudophakic. Only 5.3 % (1 patient) was vitrectomized at baseline. Previous treatments for DME included bevacizumab (10.5%), ranibizumab (57.9%), aflibercept (36.8%), triamcinolone (10.5%) and dexamethasone (89.5%). 15.8 % of the patients was under IOP lowering medication before treatment with FAc. Mean duration of DME was 2.4 ± 0.8 years and mean follow-up was 8.6 ± 5.8 months (range 1-18 months). Mean change in VA from baseline to last observation was 9.32 letters (p=0.048), (from 45.63± 22.88 to 54.95 ± 18.67 letters). Mean change in CMT from baseline to last observation was -83.54 μm (p=0.002), (from 521.87±103.38 to 438.33±112.19 μm). Mean change in MV at last observation visit was –0.11mm3 (p=0.161). Concerning safety, there was a mean IOP change from baseline to last observation of 1.21 mmHg (p=0.221), (from 17.58 ± 5.21 to 18.79 ± 4.39 mmHg). At baseline, 84.2% of the patients did not take any IOP lowering medications and at last observation visit this value remained unchanged, meaning that there was no additional requirements to treat IOP.


The results demonstrated that patients with chronic DME treated with 1 Iluvien implant achieved significant anatomic and visual outcomes similar to the outcomes obtained in the FAME studies for the same follow-up period. There were no concerns related to IOP, patients remained stable after being treated with FAc. Due to the recurrence and chronic nature of DME, long-term steroid implants become candidates for the treatment of this disease. Real-life experience demonstrates that the treatment with FAc is an effective and safe option for patients with poor response to anti-VEGFs. FAc (Iluvien) real-world data is comparable to clinical trials outcomes.



Ophthalmology Department, Setubal Hospital Center
Email : drdavidmartins@hotmail.com
Cell Phone: +351964029156
Work Phone: +351964029156