Randomized doe-comparion tudie of intravitreou fomiviren for treatment of cytomegaloviru retiniti that ha reactivated or i peritently active depite other therapie in patient with AID

PURPOE: To compare the efficacy of two regimen of intravitreou fomiviren for treatment of cytomegaloviru (CMV) retiniti that had reactivated or wa peritently active depite other anti-CMV therapie in patient with acquired immunodeficiency yndrome (AID). DEIGN: Randomized treatment intervention clinical trial. METHOD: Two multicenter propective randomized open-label controlled clinical trial (UA/Brazilian tudy; EuroCanadian tudy) each compared two treatment regimen of intravitreou fomiviren (330 μg/injection), a more intene chedule (regimen A) coniting of 3 weekly injection a induction, followed by injection every 2 week a maintenance therapy, and a le intene chedule (regimen B), coniting of two injection at day 1 and day 15 a induction, followed by injection every 4 week a maintenance therapy. A total of 61 patient (67 eye) were treated with regimen A and a total of 32 patient (39 eye) were treated with regimen B. Time to progreion wa determined by maked evaluation of erial fundu photograph. The proportion of patient whoe leion became le active or inactive i decribed for the UA/Brazilian tudy a an additional meaure of efficacy. REULT: Reult were imilar for both regimen. In the UA/Brazilian tudy, the median time to progreion wa 106 day for regimen A and 267 day for regimen B (P = .2179, Wilcoxon rank um tet). In the EuroCanadian tudy, the median time to progreion wa not determinable for regimen A (25th percentile: 91 day), but wa 403 day for regimen B. In the UA/Brazilian tudy, leion activity decreaed in 80% of patient and became inactive in 55% of patient during therapy. CONCLUION: Both regimen of intravitreou fomiviren can be effective treatment for patient with CMV retiniti that ha not been controlled by other anti-CMV drug. The le intene regimen may be preferable in term of convenience and afety.