Purpose
To determine the prevalence of, risk factors for, and visual acuity correlations with outer retinal tubulation (ORT) seen on spectral domain optical coherence tomography (SD-OCT) in eyes with neovascular age-related macular degeneration (AMD) following anti-VEGF therapy.
Design
Prospective cohort study within a randomized clinical trial.
Participants
Patients with SD-OCT images at Week 56 and 104 in the Comparison of AMD Treatment Trials (CATT).
Methods
Participants in the CATT were randomly assigned to ranibizumab (0.5mg) or bevacizumab (1.25mg) treatment and to a monthly or PRN injection-dosing regimen. A subset of eyes were imaged with SD-OCT beginning at Week 56. Cirrus 512×128 or Spectralis 20°×20° volume cube scan protocols were used to acquire SD-OCT images. Two independent readers at the CATT OCT Reading Center graded scans, and a senior reader arbitrated discrepant grades. The prevalence of ORT, identified as a tubular structures seen on at least 3 consecutive Cirrus B scans or 2 consecutive Spectralis B scans, was determined. The associations of patient-specific and ocular features at baseline and follow-up with ORT were evaluated by univariate and multivariate analyses.
Main Outcome Measures
Outer retinal tubulations.
Results
Seven of 69 eyes (10.1%) at 56 weeks and 64 of 368 (17.4%) eyes at week 104 had ORTs. Absence of diabetes, poor visual acuity (VA), blocked fluorescence, geographic atrophy (GA), greater lesion size, and presence of subretinal hyper-reflective material at baseline were independently associated with greater risk of ORT at 104 weeks (p<0.05). Neither drug nor dosing regimen were significantly associated with ORT. The mean VA of eyes with ORT at week 104 (58.5 ETDRS letters) was worse than the mean VA of eyes without ORT (68.8 letters; p<0.0001).
Conclusion
At 2 years after initiation of anti-VEGF therapy for neovascular AMD, ORTs are present in a substantial proportion of eyes. We have identified baseline features that independently predict ORTs. It is important to identify ORTs, since eyes with ORTs have worse visual acuity outcomes than those without this finding.