Purchase this article with an account.
M. S. Benz, D. M. Brown, H. Shapiro, L. Tuomi; Ranibizumab for Neovascular Age-Related Macular Degeneration (AMD): Optical Coherence Tomography (OCT) vs. Visual Acuity (VA) Changes in PIER Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):347. doi: https://doi.org/.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
The 2-yr, phase IIIb PIER study evaluated a less frequent ranibizumab dosing schedule than used in the MARINA and ANCHOR pivotal trials in patients (pts) with subfoveal choroidal neovascularization (CNV) secondary to AMD. Our retrospective analysis examined the relationship between OCT-assessed anatomical changes during year 1 and VA outcomes in PIER.
Multicenter, double-masked trial with 184 pts randomized 1:1:1 to 0.3 or 0.5 mg ranibizumab or sham injection (monthly for 3 doses, then quarterly_10 injections total). Sham-injected pts crossed over to 0.5 mg ranibizumab in year 2. VA (letters read) was assessed using ETDRS charts. OCT was performed at baseline (day 0) and months 1, 2, 3, 5, 8, and 12. For this analysis, a grader masked to treatment assignment and study eye graded OCT images (6088 scans) for qualitative lesion characteristics, including diffuse edema, intraretinal cysts, subretinal fluid, fluid below retinal pigment epithelium (RPE), and other characteristics (fibrosis, scar, atrophy, disciform, hemorrhage, etc). Results of this analysis were compared with those of quantitative OCT analysis (central foveal thickness) to determine their relationship to VA outcome.
A larger percentage of ranibizumab- than sham-treated pts were clear of edema/cysts/fluid after 3 monthly doses, but some pts had recurrent edema/ cysts/fluid after not receiving ranibizumab for 3 months. Those with no edema/cysts/fluid at month 5 had better VA outcomes at month 12 and 24. Directly comparing quantitative OCT results with VA yields limited correlation. Preliminary qualitative OCT results showed that ranibizumab-treated patients were more likely to have "anatomically normal" scans at month 3 on qualitative OCT (p<.0001). Pts who maintained "normal" anatomy had better VA outcomes.
Quantitative OCT assessments alone may not be enough to guide re-treatment or to predict VA outcomes. Further validation is necessary to assess the extent to which qualitative OCT can serve as a biomarker for anatomic effect and VA in clinical trials.
Clinical Trial: :
This PDF is available to Subscribers Only