Abstract
Purpose :
The ASSESS Study is a prospective, interventional trial of patients with neovascular age-related macular degeneration (nAMD) transitioned from other anti-VEGF therapies to intravitreal aflibercept injections (IAI). Data through 24 months demonstrated sustained improvements in anatomy and vision in patients over their previous treatment assignments. The purpose of this study was to determine the 36 month outcomes following the fixed 24 month IAI dosing regimen to a routine clinical practice regimen.
Methods :
The IRB approved study was performed at the Cole Eye Institute Cleveland Clinic. During the initial first 24 months of the study, the patients were treated monthly with 2 mg IAI for 3 months, followed by a fixed bimonthly regimen. In the third year of study, patients were managed according to routine clinical practice and two reassessment visits were performed at 30 and 36 months. Key endpoints evaluated at 36 months were the mean absolute change from baseline in central subfield thickness (CST) as measured by optical coherence tomography, mean change in E-ETDRS best corrected visual acuity, and the predictive factors associated with improved visual and anatomical outcomes after IAI.
Results :
From the initial cohort of 26 patients, a total of 18 patients completed the 36 months study. Patients received an average of 3.7 (SD=2.2) anti-VEGF injections and had 7.5 ± 1.8 office visits in the third year. At 24 months, there was a significant decrease in CST from baseline of 41.0 µm (p<0.001), whereas at 36 months, a non-significant mean decrease from baseline of 37.9 µm (p=0.087) was observed. Likewise, at 24 months, there was a significant gain of 10.4 ETDRS letters from baseline (p<0.001). However, at 36 months, a significant gain of 5.8 ETDRS letters from baseline (p<0.047) was still observed. No predictive factors were identified for changes in BCVA and CST and no serious adverse events were reported in the third year of study.
Conclusions :
When patients were transitioned to a routine clinical practice regimen from a bimonthly fixed-dosing regimen using IAI, there was a trend of decreased visual and anatomic improvements.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.