In a nutshell
This study looked at the real-life use of fluocinolone acetonide (Iluvien) inserts for the treatment of diabetic macular edema (DME). They found that this treatment results in a significant increase in vision over three years.
Some background
DME is a major cause of vision loss in diabetic patients. DME consists of the accumulation of fluid at the back of the eye (retina). This fluid causes swelling in the central part of the retina (macula). Injecting steroids into the eye can help to improve DME.
Fluocinolone acetonide (FAc) inserts have been designed to release steroids slowly into the eye over a period of three years. In clinical trials, these inserts have been shown to be very effective. However real-world results are not always the same as clinical trials as patients are carefully selected for clinical trials. Therefore, it is important to evaluate if real-world data is similar to that of clinical trials for FAc inserts in patients with DME.
Methods & findings
This study compared the results of nine real-world studies using FAc eye inserts. A total of 428 eyes were included. Vision was checked 24 and 36 months after the insert was injected. Results of these real-world trials were compared to one large clinical trial.
After 24 months the vision in injected eyes improved by an average of 4.5 letters on the vision chart. After 36 months the vision in injected eyes improved by an average of 8.1 letters on the vision chart.
Central macular swelling was significantly reduced at 24 and 36 months. 39% of patients in the real-life studies needed additional eye therapy. This was compared to 15.2% in clinical trial data.
The bottom line
This study showed that real-life results with fluocinolone acetonide eye implants are similar to clinical trial results.
The fine print
This study involved comparing other studies which had different designs. This makes it difficult to compare results exactly. More studies are needed to confirm these results.
Published By :
Scientific reports
Date :
Feb 26, 2021