Data support adding suprachoroidal injection to anti-VEGF for RVO
Additive approach augments results of intravitreal anti-VEGF with encouraging safety profile
About the study
TANZANITE was a multicenter, masked phase II study that randomly assigned 46 patients equally to the combination or monotherapy treatment groups. Eligible patients had macular edema secondary to RVO that was present for no longer than 12 months, best-corrected visual acuity (BCVA) between 20 and 70 letters, and had received no prior treatment for the macular edema.
Patients were followed monthly over 3 months and received additional aflibercept as needed according to protocol-specified criteria.
The study met its primary endpoint, finding that the total number of additional aflibercept injections administered was significantly lower (–61%) in eyes treated with the suprachoroidal corticosteroid compared with the monotherapy controls (9 versus 23 injections).
In addition, the proportion of patients who received no additional aflibercept injections was significantly less in the combination therapy group compared with the controls (78% versus 30%, respectively).
Changes in BCVA and central subfield thickness (CST) were analyzed as secondary endpoints. The functional assessments showed an early difference in BCVA improvement favoring the combination treatment group that increased with longer follow-up despite the greater number of aflibercept injections received by the monotherapy group.
At month 1, eyes receiving suprachoroidal triamcinolone acetonide had gained 16.1 letters from baseline BCVA compared with an improvement of 11.3 letters in the controls. The average gain from baseline at 3 months was 18.9 letters in the combination arm and remained 11.3 letters in the control group.
The eyes treated with combination therapy also had greater reduction in macular edema at month 1 and at the end of the study.
Mean CST at baseline was about 730 μm in both groups. In the combination therapy arm, mean CST was 285 μm at month 1 and was the same at month 3. In the monotherapy arm, mean CST was 323 μm at month 1 and 384 μm at month 3.