Safety and Efficacy of Conbercept in Neovascular Age-Related Macular Degeneration

• Published in: Ophthalmology (Rochester, Minn.) Vol. 121; no. 9; pp. 1740 - 1747
• Main Authors: Li, Xiaoxin, MD, PhD, Xu, Gezhi, MD, Wang, Yusheng, MD, Xu, Xun, MD, Liu, Xiaoling, MD, Tang, Shibo, MD, Zhang, Feng, MD, Zhang, Junjun, MD, Tang, Luosheng, MD, Wu, Quan, PhD, Luo, Delun, BS, Ke, Xiao, BS
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.09.2014
• Subjects: Ophthalmology; OCT; CRT; fluorescein angiography; optical coherence tomography; CNV; FP; CLEAR-IT; Q1M; PRN; pro re nata; fundus photography; ICGA; central retinal thickness; AMD; age-related macular degeneration; AURORA; Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Agerelated Macular Degeneration (AMD); AE; choroidal neovascularization; VEGF; adverse event; BCVA; indocyanine green angiography; severe adverse event; SAE; vascular endothelial growth factor; best-corrected visual acuity; monthly; FA; Assess the safety and efficacy of KH902 in patients with sUbfoveal choroidal neovasculaRization secOndary to age-Related mAcular degeneration; EXCITE; CLinical Evaluation of Anti-angiogenesis in the Retina Intravitreal Trial
• ISSN: 0161-6420; 1549-4713
• DOI: 10.1016/j.ophtha.2014.03.026

Purpose To assess the safety and efficacy of multiple injections of 0.5 and 2.0 mg conbercept using variable dosing regimens in patients with neovascular age-related macular degeneration (AMD). Design Randomized, double-masked, multicenter, controlled-dose, and interval-ranging phase 2 clinical trial divided into a 3-month loading phase followed by a maintenance phase. Participants Patients with choroidal neovascularization secondary to AMD with lesion sizes of 12 disc areas or less and a best-corrected visual acuity (BCVA) letter score of between 73 and 24 were enrolled. Methods Patients were randomized 1:1 to receive either 0.5 or 2.0 mg intravitreal conbercept for 3 consecutive monthly does. After the third dose, each group was reassigned randomly again to monthly (Q1M group) or as-needed (pro re nata [PRN] group) treatment without changing the drug assignment. Main Outcome Measures The primary end point was the mean change in BCVA from baseline to month 3, with secondary end points being the mean change in BCVA, mean change in central retinal thickness (CRT), and safety at month 12. Results We enrolled 122 patients. At the primary end point at month 3, mean improvements in BCVA from baseline in the 0.5- and 2.0-mg groups were 8.97 and 10.43 letters, respectively. At month 12, mean improvements in BCVA from baseline were 14.31, 9.31, 12.42, and 15.43 letters for the 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 the 4 regimens were 119.8, 129.7, 152.1, and 170.8 μm, respectively. There were no significant differences for the pairwise comparisons between all study groups. The difference in the number of injections between the 2 PRN groups was not statistically significant. Treatment with conbercept generally was safe and well tolerated. Conclusions The significant gains in BCVA at 3 months were the same or better at 12 months in all conbercept dosing groups of neovascular AMD patients. During the 12 months, repeated intravitreal injections of conbercept were well tolerated in these patients. Future clinical trials are required to confirm its long-term efficacy and safety.