Sustained ocular delivery of fluocinolone acetonide by an intravitreal insert.
OBJECTIVE
To compare Iluvien intravitreal inserts that release 0.2 or 0.5 microg/day of fluocinolone acetonide (FA) in patients with diabetic macular edema (DME).


METHODS
Prospective, randomized, interventional, multicenter clinical trial.


METHODS
We included 37 patients with DME.


METHODS
Subjects with persistent DME despite > or = 1 focal/grid laser therapy were randomized 1:1 to receive an intravitreal insertion of a 0.2- or a 0.5-microg/day insert.


METHODS
The primary end point was aqueous levels of FA throughout the study with an important secondary outcome of the change from baseline in best-corrected visual acuity (BCVA) at month 12.


RESULTS
The mean aqueous level of FA peaked at 3.8 ng/ml at 1 week and 1 month after administration of a 0.5-microg/day insert and was 3.4 and 2.7 ng/ml 1 week and 1 month after administration of a 0.2-microg/day insert. For both inserts, FA levels decreased slowly thereafter and were approximately 1.5 ng/ml for each at month 12. The mean change from baseline in BCVA was 7.5, 6.9, and 5.7 letters at months 3, 6, and 12, respectively, after administration of a 0.5 microg/day-insert and was 5.1, 2.7, and 1.3 letters at months 3, 6, and 12, respectively, after administration of a 0.2-microg/day insert. There was a mild increase in mean intraocular pressure after administration of 0.5-microg/day inserts, but not after administration of 0.2-microg/day inserts.


CONCLUSIONS
The FA intravitreal inserts provide excellent sustained intraocular release of FA for > or = 1 year. Although the number of patients in this trial was small, the data suggest that the inserts provide reduction of edema and improvement in BCVA in patients with DME with mild effects on intraocular pressure over the span of 1 year.


BACKGROUND
Proprietary or commercial disclosure may be found after the references.
Campochiaro
Peter A
PA
The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-9277, USA. pcampo@jhmi.edu
Hafiz
Gulnar
G
Shah
Syed Mahmood
SM
Bloom
Steven
S
Brown
David M
DM
Busquets
Miguel
M
Ciulla
Thomas
T
Feiner
Leonard
L
Sabates
Nelson
N
Billman
Kathleen
K
Kapik
Barry
B
Green
Ken
K
Kane
Frances
F
D001082:Aqueous Humor / Q000378:metabolism; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000378:metabolism; D016503:Drug Delivery Systems; D004343:Drug Implants; D005446:Fluocinolone Acetonide / Q000008:administration & dosage* / Q000493:pharmacokinetics; D005451:Fluorescein Angiography; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000493:pharmacokinetics; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects; D008269:Macular Edema / Q000188:drug therapy* / Q000378:metabolism; D011446:Prospective Studies; D012160:Retina / Q000187:drug effects; D053719:Tandem Mass Spectrometry; D041623:Tomography, Optical Coherence; D014792:Visual Acuity / Q000187:drug effects; D014822:Vitreous Body
D004343:Drug Implants; D005938:Glucocorticoids; D005446:Fluocinolone Acetonide