Purpose:
Examine the effect of rescue laser (RL) on efficacy outcomes in BRAVO
Methods:
Patients with macular edema (ME) following branch retinal vein occlusion (BRVO) received 6 monthly intravitreal injections of 0.3 mg (n=134) or 0.5 mg (n=131) ranibizumab or sham injections (sham/0.5 mg, n=132) (treatment period, Day 0-Month 5) followed by 6 months of observation (observation period Months 6-11), during which eligible patients could receive PRN ranibizumab. Patients could also receive RL once during the treatment period and once during the observation period if visual and anatomic criteria were met. We described the frequency of RL use for each treatment group and compared changes from baseline best-corrected visual acuity (BCVA) and central foveal thickness (CFT) at Month 12 in subgroups of patients who did vs. did not receive RL. We also evaluated subgroup baseline characteristics (age, gender, prior treatment for RVO, time from diagnosis to Day 0, BCVA, CFT).
Results:
At the end of the 12-month study, 61.4% (sham/0.5 mg), 41.0% (0.3 mg), and 34.4% (0.5 mg) of patients had received at least one RL treatment. Patients in the 0.5 mg group who received RL had a smaller mean change from baseline BCVA compared with those who did not receive RL (15.0 vs. 20.1 letters, p=0.006); 0.3 mg patients who received RL had a longer mean time from diagnosis to Day 0 than those who did not receive RL (5.2 vs. 3.6 months, p=0.026); and 0.5 mg patients who received RL were older, on average, than those who did not receive RL (70.5 vs. 65.9 years, p=0.024).
Conclusions:
On average, patients with ME following BRVO who required and received RL in BRAVO did not attain the level of BCVA gains as those who did not require or receive RL. There was no consistent association between baseline characteristics and RL treatment.
Clinical Trial:
http://www.clinicaltrials.gov NCT00486018
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • edema • injection