Agreement of Spectral Domain Optical Coherence Tomography with Fluorescein Leakage in Neovascular Age-related Macular Degeneration: Post Hoc Analysis of the HARBOR Study.

PURPOSE: To evaluate the agreement between detection of activity of choroidal neovascularization (CNV) in neovascular age-related macular degeneration (AMD) by fundus fluorescein angiography (FFA) and spectral domain (SD)- optical coherence tomography (OCT) in the HARBOR study. Most retina specialists rely on OCT to guide treatment decisions in neovascular AMD. However, OCT may not always detect exudative activity. Traditionally, FFA was frequently performed in clinical practice, but its use has diminished due to reliance on OCT. DESIGN: Retrospective Post Hoc Analysis of Prospective Clinical Trial (HARBOR; clinicaltrials.gov identifier, NCT00891735) PARTICIPANTS: Baseline to Month 24 data from all randomized study eyes in HARBOR with both FFA and SD-OCT data were analyzed for 1) Evidence of CNV activity on SD- OCT (presence of subretinal fluid, intraretinal fluid, and/or cystoid spaces); 2) Evidence of CNV activity on FFA identified by the presence of leakage 3) Cross tabulation of CNV activity identified by FFA and SD-OCT by office visit. MAIN OUTCOME MEASURE: The percent agreement between FFA and SD-OCT in detecting CNV activity and sensitivity and specificity of SD-OCT to detect fluorescein leakage in neovascular AMD using FFA as the reference standard. RESULTS: At baseline, 1094 cases (99.9%) had agreement between SD-OCT and FFA in detecting CNV activity. By Month 24, of the 779 total active cases the agreement was only 36% (277 cases). By month 24 most cases (n= 452, 58%) had evidence of CNV activity on SD-OCT only, while 6% of cases (n=50) had CNV activity identified by FFA only. At screening and months 3, 6, 12, and 24, 92-100% of cases identified by FFA only were occult CNV lesions. Using FFA as the reference standard, the sensitivity and specificity of SD-OCT in detecting CNV activity was 91% (95% CI: 84%, 99%) and 13% (95% CI: 4%, 22%). CONCLUSION: SD-OCT alone can be relied upon for detecting CNV activity while monitoring eyes with neovascular AMD. However, FFA may still be of value in those with occult lesions that appear quiescent on SD-OCT, as this type of lesion may show leakage on FFA.