ABSTRACT

Introduction:

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.

Methods:

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.

Results:

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.

Conclusions:

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.


CONTACT DETAILS

 

David MARTINS*, Ines MATIAS, Pedro NEVES, Silvia DINIZ, Pedro GOMES, Joao RODRIGUEZ, Mario ORNELAS
Ophthalmology Department, Setubal Hospital Center
Setubal
Portugal
Email : drdavidmartins@hotmail.com
Cell Phone: +351964029156
Work Phone: +351964029156