Abstract
Purpose: :
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).
Methods: :
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.
Results: :
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.
Conclusions: :
In this study of patients with RVO, baseline BCVA was significantly associated with the type of RVO (central vs branch), retinal thickness, and age.
Clinical Trial: :
www.clinicaltrials.gov NCT00168298
Keywords: vascular occlusion/vascular occlusive disease • macula/fovea • inflammation