Abstract
Purpose :
To quantitatively evaluate the longitudinal ellipsoid zone (EZ) alterations following intravitreal ocriplasmin in a prospective, observational phase 4 clinical trial.
Methods :
The ORBIT study is a phase 4 observational clinical study examining the real-world use of intravitreal ocriplasmin. This study was a sub-analysis of imaging features following ocriplasmin injection. Inclusion criteria included the following: (1) available SD-OCT scans at baseline (BL) and week 1. (2) Available SD-OCT at month 1, month 3, or month 6. Exclusion criteria included: (1) SD-OCT scans of limited quality for segmentation analysis, (2) lack of macular cube scan, and (3) significant macular pathology (other than vitreomacular interface disease) resulting in anatomic alterations (e.g., drusen). Macular cube scans were imported into a novel EZ mapping platform utilizing a previously validated and reported software platform. Quantitative assessments for EZ alterations were assessed.
Results :
Fifty-five subjects were included in this analysis. Final visit was assessed based on the latest available SD-OCT which included month 1 (n = 22), month 3 (16), and month 6 (17). The average total macular EZ-RPE volume was 1.12 mm3 at BL, which decreased to 0.89 mm3 at week 1 and recovered to 94% of BL value at final visit. En face EZ atrophy increased from an average of 2.9% at BL to 14.9% at week 1, and improved to 6.8% at final visit. En face EZ attenuation (< 20 micron thickness) increased from an average of 5.1% at BL to 29.4% at week 1, and recovered to 11.7% at final visit. At final follow-up, 3 of 55 subjects were defined as outliers (i.e., 2 standard deviations above the mean) and did not appear to experience EZ recovery with persistent en face EZ atrophy > 20% and en face EZ attenuation >30% map area.
Conclusions :
Intravitreal ocriplasmin resulted in EZ attenuation that is noted at 1-week. Generally, these changes were transient and predominantly recovered between month 1 and month 6 following therapy. Three of 55 subjects were noted to have significant persistent EZ attenuation. Additional research is needed to further evaluate the overall impact of these anatomic outcomes with functional features.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.