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M. C. Gillies, J. A. Haller, J. Jiao, X.-Y. Li, S. M. Whitcup; Changes in Visual Acuity in Sham-Treated Patients in a Randomized, Controlled, 6-Month Trial of an Applicator-Delivered Dexamethasone Intravitreal Implant in Patients With Macular Edema Due to Branch or Central Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2010;51(13):4729.
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To evaluate changes in best-corrected visual acuity (BCVA) in sham-treated (ST) patients in a study of OZURDEXTM (dexamethasone intravitreal implant) against ME.
Two identical, double-masked trials randomized patients with ME due to CRVO or BRVO to receive DEX Implant 0.35 mg (n=414) or 0.7 mg (n=427) or a sham procedure (n=426). Masked technicians measured BCVA by using ETDRS chart. Logistic regression was used to analyze the association between BCVA improvement and demographics/medical history of ST-BRVO (n=249) and ST-CRVO (n=133) patients with no prior ME treatment.
In ST eyes, peak mean change in BCVA from baseline was 3 letters at Day 90. The onset of ≥3-line (15-letter) improvement occurred within 60 days in 7% to 12% of ST eyes, reaching a peak of 18% at Day 180. More eyes improved ≥3 lines in the BRVO group than the CRVO group at Day 180 (20% vs 12%). The odds (odds ratio [CI]) of having improved BCVA at Day 180 was negatively associated with age (0.914 [0.883, 0.945]; P < .001), retinal thickness (0.996 [0.995, 0.998]; P < .001), and absence of cataract (0.288 [0.146, 0.568]; P=.0003) in the ST-BRVO group but only with retinal thickness (0.997 [0.995, 0.999]; P=.0047) in the ST-CRVO group.
BCVA was improved in some ST patients. Predictors of improvement were retinal thickness in both groups and age and cataract in the ST-BRVO group. The dearth of accurate predictors for spontaneous improvement might be taken into account for planning when to start therapy with agents of proven efficacy.
Clinical Trial: :
www.clinicaltrials.gov NCT00168298 , NCT00168324
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