422 million people suffer from diabetes worldwide, a third of these people have diabetic retinopathy, of which a third can lose vision and have diabetic macular edema. Diabetic macular edema occurs due to the deterioration of the blood-retinal barrier and increased vascular permeability caused by anatomical and biochemical changes.
For many years, laser treatment was the most used to treat this pathology, sometimes accompanied by corticosteroid injections with short-term results. In recent years, the laser has been replaced by anti-vascular endothelial growth factor agents (bevacizumab, ranibizumab and aflibercept). However, a portion of the treated patients do not respond to this treatment.
In 2013, NICE approved fluocinolone acetonide as an alternative treatment for patients who do not respond to other treatments. The aim of the present study was to evaluate the efficacy and safety of the fluocinolone acetonide implant in patients with diabetic macular edema in a specialist center in the United Kingdom.
Patients and methods
Retrospective evaluation of patients with diabetic macular edema in a specialized center, who did not respond to conventional treatment and were treated with fluocinolone acetonide implant according to UK guidelines.
The outcomes evaluated were best-corrected visual acuity, macular status according to optical coherence tomography, new increases in IOP >27mmHg, or glaucoma surgery. Patients with a follow-up >1 year were excluded.
The present study provides some of the first data in professional practice on the effect and safety of the fluocinolone acetonide 0.19 mg implant for patients with diabetic macular edema, with three years of follow-up.
Our results coincide with those of the FAME study, 50% of the eyes in our series gained 15 letters or more in the three-year follow-up, eyes with chronic diabetic macular edema obtained a greater effect on visual acuity. In the present study, the effects of AF implantation were maintained at 36 months in those who responded to treatment.
The need for supplementary treatment after three years has also been evaluated , which was observed in 34% of eyes at one year, 60% at 2 years, and 83.3% at three years. None of the patients required new treatment with FA implant after three years.
Reduction in injection burden is an important benefit of the FA implant, as the high frequency of intravitreal injections has been shown to affect quality of life, increase anxiety, and require patients to take time off work. The reduced need for repeat treatment also contributes to the cost-effectiveness of the FA implant.
We also observed, as in another study, that the FA implant is effective in eyes with vitrectomy. Of the three eyes in the series with vitrectomy, only one required new treatment at follow-up, at 1.8 years.
The main drawbacks of AF implantation are cataracts and glaucoma
Cataracts occur in 82-89% of phakic eyes within three years of implantation, which led to its implantation being recommended in the United Kingdom for pseudophakic patients with diabetic macular edema. In the present study, 97% of the eyes were pseudophakic by virtue of this recommendation. However, today cataract surgery is a very successful and safe procedure; the implant should not be prevented in phakic patients, with the treatment being successful.
Although it is less common than cataracts, the biggest problem is elevated intraocular pressure. In the FAME study, 37% of participants had elevated IOP in the FA group and 12% in the control group, and glaucoma surgery was required in 4.8% in the first group. In the present study, 2 of the 33 eyes had increased IOP and both had a history. These patients were treated with medication without the need for surgery.
Despite the limitations in terms of retrospective nature and small number of patients, the results of the present study coincide with those of the FAME trial and support it with the results in professional practice.
| Conclusions |
The present study shows that there is an improvement in visual acuity on average of 8.5 letters at 3 years, associated with a reduction in the thickness of the central retina and peak thickness of the macula.
Although not all patients completed the 3-year follow-up, 50% of these patients had an improvement of 15 letters or more at the end of follow-up greater than the 34% observed in the FAME study. FA implantation appears to provide benefits in pseudophakic patients with diabetic macular edema who do not respond to conventional treatments.
Likewise, this implant has the advantage of fewer controls and less frequent injections. These results support those of the FAME study, the FA implant can be used safely and significantly improve visual acuity, reducing macular edema with a lower cost and treatment burden for this vision-threatening pathology.
