PMID- 21813090
OWN - NLM
STAT- MEDLINE
DCOM- 20110921
LR  - 20220309
IS  - 1549-4713 (Electronic)
IS  - 0161-6420 (Linking)
VI  - 118
IP  - 8
DP  - 2011 Aug
TI  - Fluocinolone acetonide intravitreal implant for diabetic macular edema: a 3-year 
      multicenter, randomized, controlled clinical trial.
PG  - 1580-7
LID - 10.1016/j.ophtha.2011.02.048 [doi]
AB  - PURPOSE: We studied the 3-year efficacy and safety results of a 4-year study 
      evaluating fluocinolone acetonide (FA) intravitreal implants in eyes with 
      persistent or recurrent diabetic macular edema (DME). DESIGN: Prospective, 
      evaluator-masked, controlled, multicenter clinical trial. PARTICIPANTS: We 
      included 196 eyes with refractory DME. METHODS: Patients were randomized 2:1 to 
      receive 0.59-mg FA implant (n = 127) or standard of care (SOC additional laser or 
      observation; n = 69). The implant was inserted through a pars plana incision. 
      Visits were scheduled on day 2, weeks 1, 3, 6, 12, and 26, and thereafter every 
      13 weeks through 3 years postimplantation. MAIN OUTCOME MEASURES: The primary 
      efficacy outcome was >/=15-letter improvement in visual acuity (VA) at 6 months. 
      Secondary outcomes included resolution of macular retinal thickening and Diabetic 
      Retinopathy Severity Score (DRSS). Safety measures included incidence of adverse 
      events (AEs). RESULTS: Overall, VA improved >/=3 lines in 16.8% of implanted eyes 
      at 6 months (P=0.0012; SOC, 1.4%); in 16.4% at 1 year (P=0.1191; SOC, 8.1%); in 
      31.8% at 2 years (P=0.0016; SOC, 9.3%); and in 31.1% at 3 years (P=0.1566; SOC, 
      20.0%). The number of implanted eyes with no evidence of retinal thickening at 
      the center of the macula was higher than SOC eyes at 6 months (P<0.0001), 1 year 
      (P<0.0001; 72% vs 22%), 2 years (P=0.016), and 3 years (P=0.861). A higher rate 
      of improvement and lower rate of decline in DRSS occurred in the implanted group 
      versus the SOC group at 6 months (P=0.0006), 1 year (P=0.0016), 2 years 
      (P=0.012), and 3 years (P=0.0207). Intraocular pressure (IOP) >/=30 mmHg was 
      recorded in 61.4% of implanted eyes (SOC, 5.8%) at any time and 33.8% required 
      surgery for ocular hypertension by 4 years. Of implanted phakic eyes, 91% (SOC, 
      20%) had cataract extraction by 4 years. CONCLUSIONS: The FA intravitreal implant 
      met the primary and secondary outcomes, with significantly improved VA and DRSS 
      and reduced DME. The most common AEs included cataract progression and elevated 
      IOP. The 0.59-mg FA intravitreal implant may be an effective treatment for eyes 
      with persistent or recurrent DME. FINANCIAL DISCLOSURE(S): Proprietary or 
      commercial disclosure may be found after the references.
CI  - Copyright (c) 2011 American Academy of Ophthalmology. Published by Elsevier Inc. 
      All rights reserved.
FAU - Pearson, P Andrew
AU  - Pearson PA
AD  - Department of Ophthalmology and Visual Science, University of Kentucky, 
      Lexington, Kentucky, USA.
FAU - Comstock, Timothy L
AU  - Comstock TL
FAU - Ip, Michael
AU  - Ip M
FAU - Callanan, David
AU  - Callanan D
FAU - Morse, Lawrence S
AU  - Morse LS
FAU - Ashton, Paul
AU  - Ashton P
FAU - Levy, Brian
AU  - Levy B
FAU - Mann, Eric S
AU  - Mann ES
FAU - Eliott, Dean
AU  - Eliott D
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Ophthalmology
JT  - Ophthalmology
JID - 7802443
RN  - 0 (Drug Implants)
RN  - 0 (Glucocorticoids)
RN  - 0CD5FD6S2M (Fluocinolone Acetonide)
SB  - IM
MH  - Cataract/chemically induced
MH  - Diabetic Retinopathy/diagnosis/*drug therapy/physiopathology
MH  - Double-Blind Method
MH  - Drug Implants
MH  - Female
MH  - Fluocinolone Acetonide/*administration & dosage/adverse effects
MH  - Fluorescein Angiography
MH  - Glucocorticoids/*administration & dosage/adverse effects
MH  - Humans
MH  - Intraocular Pressure/drug effects/physiology
MH  - Macular Edema/diagnosis/*drug therapy/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Recurrence
MH  - Retina/drug effects/pathology
MH  - Tomography, Optical Coherence
MH  - Treatment Outcome
MH  - Visual Acuity/drug effects/physiology
MH  - Vitreous Body/*drug effects
EDAT- 2011/08/05 06:00
MHDA- 2011/09/22 06:00
CRDT- 2011/08/05 06:00
PHST- 2010/02/09 00:00 [received]
PHST- 2011/02/23 00:00 [revised]
PHST- 2011/02/28 00:00 [accepted]
PHST- 2011/08/05 06:00 [entrez]
PHST- 2011/08/05 06:00 [pubmed]
PHST- 2011/09/22 06:00 [medline]
AID - S0161-6420(11)00235-1 [pii]
AID - 10.1016/j.ophtha.2011.02.048 [doi]
PST - ppublish
SO  - Ophthalmology. 2011 Aug;118(8):1580-7. doi: 10.1016/j.ophtha.2011.02.048.