Abstract
Purpose :
This study was to compare the combination of suprachoroidal triamcinolone acetonide (CLS-TA) with intravitreal aflibercept vs intravitreal aflibercept monotherapy in patients with retinal vein occlusion with a specific focus on perfusion status
Methods :
This prospective IRB-approved study compared aflibercept monotherapy to aflibercept with suprachoroidal CLS-TA. Patients were retreated prn only with intravitreal aflibercept in both groups, if there was fluid above 340 µm in central subfield thickness (CST) on OCT or a decrease in BCVA of 10 letters from the prior visit, or if there was a 50 µm fluid increase with a 10 letter drop from the best BCVA reading. The primary endpoint was the number of additional intravitreal aflibercept injections over 3 months. Secondary endpoints included changes in BCVA and CST thickness by OCT. Planned exploratory analysis included retinal perfusion status as deteremined by flourescein angiography.
Results :
46 patients were randomized 1:1 into two arms. Patients in the combination arm had 61% (14) fewer additional aflibercept injections than the monotherapy arm. At 3 months the combination group gained 18.9 letters vs. 11.3 letters in the monotherapy group. In addition at month 3, 52.2% of patients gained ≥15 letters in the combination group vs. 43.5% of patients in the monotherapy group. CST was reduced by 446 µm in the combination therapy group vs. 343 µm in the monotherapy group. Average CFT was 285 µm in the combination therapy group vs. 384 µm in the monotherapy group from baselines of 731 µm and 728 µm respectively.
Subset analysis was performed on perfusion status. In ischemic patients, BCVA improved 7 letters more in combination vs monotherapy. In non ischemic patients, combination therapy improved 8 letters more than mono therapy. In terms of change on OCT in non ischemic patients combination therapy OCT CST decreased by 106 µm vs monotherapy, and in ischemic patients, combination therapy decreased OCT CFT by 69 µm vs monotherapy.
Conclusions :
Combination therapy resulted in more patients with increased visual acuity, decreased OCT thickness, and decreased injections vs aflibercept monotherapy in patients with RVO under the conditions of this phase 2 study. These apparently better results were maintained regardless of perfusion status.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.