Diabetic macular edema outcomes in eyes treated with fluocinolone acetonide 0.2 µg/d intravitreal implant: real-world UK experience.
OBJECTIVE
To conduct an observational, multicenter study to evaluate real-world clinical efficacy and safety of the 0.2 µg/day fluocinolone acetonide (FAc) implant in the treatment of patients with chronic diabetic macular edema (DME) in 3 large hospital ophthalmology departments in the United Kingdom.


METHODS
Fluocinolone acetonide implants were inserted into the study eyes following a suitable washout period; phakic eyes received FAc implant following cataract surgery. Follow-up visits took place 2-4 weeks postinjection and then at 3, 6, and 12 months; change in central macular thickness (CMT) from baseline was measured by optical coherence tomography and best-corrected visual acuity (BCVA) was also assessed. Adverse events and changes in intraocular pressure (IOP) were recorded in order to evaluate the safety profile for the FAc implant.


RESULTS
Improvements in BCVA and CMT were observed from 3 months and sustained for the duration of observation. At 12 months, the overall mean change from baseline CMT was -126 μm and mean increase in BCVA from baseline was 5.1 letters. Increases in IOP following FAc implant were easily managed with IOP-lowering medication. Implant migration into the anterior chamber occurred in 2 eyes where prior vitrectomy had resulted in a posterior capsule defect; this was rectified and resolved.


CONCLUSIONS
The results of this study provide further efficacy and safety profile data for FAc implant treatment of chronic DME in a real-world clinical setting; the FAc implant appears to be a valuable therapeutic approach for patients with chronic DME who have suboptimal response to other treatment options.
Ophthalmology Department, James Cook University Hospital, Middlesbrough - UK.
Ibraheem
I
El-Ghrably
Ophthalmology Department, Sunderland Eye Infirmary, Sunderland - UK.|Institute of Genetic Medicine, Newcastle University, Newcastle Upon Tyne - UK.
David H W
DHW
Steel
Ophthalmology Department, Sunderland Eye Infirmary, Sunderland - UK.
Maged
M
Habib
Ophthalmology Department, James Cook University Hospital, Middlesbrough - UK.
Daniela
D
Vaideanu-Collins
Ophthalmology Department, James Cook University Hospital, Middlesbrough - UK.
Sridhar
S
Manvikar
Newcastle Eye Centre, Royal Victoria Infirmary, Newcastle Upon Tyne - UK.
Roxane J
RJ
Hillier
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003930:Diabetic Retinopathy / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004343:Drug Implants; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage*; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D058449:Intravitreal Injections; D008269:Macular Edema / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D041623:Tomography, Optical Coherence; D006113:United Kingdom; D014792:Visual Acuity
D004343:Drug Implants; D005938:Glucocorticoids; D005446:Fluocinolone Acetonide