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S. M. Whitcup, J. Heier, J. Haller, M.-L. Jacques, X.-Y. Li, H. Cui, Posurdex RVO Study Group; Characteristics Related to Baseline Visual Acuity in a Multicenter, Randomized, Sham-Controlled Trial of an Applicator-Delivered Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) in Patients with Macular Edema due to Retinal Vein Occlusion. Invest. Ophthalmol. Vis. Sci. 2009;50(13):5407.
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To determine characteristics related to baseline best-corrected visual acuity (BCVA) in a trial of applicator-delivered DEX PS DDS for the treatment of macular edema (ME) associated with central or branch retinal vein occlusion (RVO).
In this multicenter, randomized, double-masked study, patients with ME (duration 1.5-9 months for CRVO; 1.5-12 months for BRVO) due to RVO were randomized to receive 350µg (n=218) or 700µg DEX PS DDS (n=226) or a sham procedure (n=224). Baseline characteristics evaluated included demographics; type, duration, and prior treatment of ME; BCVA; and retinal thickness as measured by OCT. Linear regression analysis was used to evaluate the relationship between baseline BCVA and other baseline characteristics.
Mean age was 64 years, 52% were male, 35% had CRVO and 65% had BRVO. Prior to study entry, 53% of patients had macular edema for 90-179 days, 6% had used medication for ME, and 9% had a procedure for ME. Mean baseline retinal thickness was 561 µm overall (CRVO = 640, BRVO = 518). Mean baseline BCVA was 54.4 letters overall, 52.0 for CRVO, and 55.6 for BRVO, and this difference in BCVA was statistically significant (BRVO vs CRVO; P=.006). In addition, baseline BCVA was significantly correlated with baseline retinal thickness (P<.001) and age (P≤.024) in the overall population, and both CRVO and BRVO subgroups. A 100-µm increase in retinal thickness was associated with decreased BCVA of 1.3 letters in all patients (CRVO = 1.5, BRVO = 1.1). Every 10 years of age increase was associated with decreased BCVA of 1.5 letters in all patients (CRVO = 1.2, BRVO = 1.7). There was no significant association between BCVA and gender, ME duration, or use of prior RVO treatments.
In this study of patients with RVO, baseline BCVA was significantly associated with the type of RVO (central vs branch), retinal thickness, and age.
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