Session Title: AMD III
Session Date/Time: Sunday 29/09/2013 | 11:00-13:00
Paper Time: 12:28
Venue: Hall G1 (Level 2)
First Author: X.Li CHINA
To access the safety and efficacy of multiple injections of 0.5 mg and 2.0 mg of conbercept and combined with variable dosing regimens in patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Randomized, double-masked, multicenter, parallel controlled Dose- and Interval-ranging phase II clinical trial in China
patients were randomized in a 1:1 ratio to receive either 0.5 mg or 2.0 mg of 3 times monthly intravitreal injection of conbercept. After the 3-month loading phase, every dose group was reassigned randomly again to monthly (Q1M group) or as-needed (PRN group) treatment, without changing the drug assignment.
At the primary end point at month 3, mean improvements in BCVA from baseline in 0.5 mg and 2.0 mg groups were 8.97 and 10.43 letters, respectively. After the maintenance phase treatment, at month 12 mean improvements in BCVA were 14.31, 9.31, 12.42, and 15.43 letters for 0.5 mg PRN, 0.5 mg Q1M, 2.0 mg PRN, and 2.0 mg Q1M regimens, respectively. At month 12 mean reductions in CRT in 4 regimen groups were 119.8 μm, 129.7 μm, 152.1 μm and 170.8 μm. There were no significant different of outcomes for the pair wise comparisons between all study groups. Treatment with conbercept was generally safe and well tolerated. There were some ocular or systemic adverse events.
Significant gains in BCVA from baseline achieved at month 3 were maintained or improved at month 12 in all conbercept dosing regimens groups. During a span of 12-month observation, repeated intravitreal injection of conbercept was well tolerated in neovascular AMD.