NCT03630952

Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2)

A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects With Neovascular Age-Related Macular Degeneration (AMD) (PANDA-2)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,157 (actual)
• Sponsor: Chengdu Kanghong Biotech Co., Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea®), in subjects with neovascular AMD.

Detailed description

A multicenter, multinational, double-masked, parallel-group, dose-ranging, active-controlled, randomized trial, which will randomize approximately 1140 subjects in a ratio of 1:1:1 to receive IVT injections of 0.5 mg conbercept, 1.0 mg conbercept, or 2.0 mg aflibercept. The trial includes a screening period of less than or equal to 14 days, followed by a treatment period of 92 weeks (last assessment at 96 weeks) with primary efficacy analysis at 36 weeks.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
BIOLOGICAL	0.5 mg Conbercept Intravitreal Injection	Subjects received 0.5 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (0.5 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based pro re nata (PRN) approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
BIOLOGICAL	1.0 mg Conbercept Intravitreal Injection	Subjects received 1.0 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every twelve weeks thereafter (1.0 mg, q12w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
BIOLOGICAL	2.0 mg Aflibercept Intravitreal Injection	Subjects received 2.0 mg aflibercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (2.0 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.

Timeline

• Start date: 2018-12-21
• Primary completion: 2020-09-10
• Completion: 2021-05-19
• First posted: 2018-08-15
• Last updated: 2021-06-23

Locations

154 sites across 12 countries: United States, Bulgaria, China, Czechia, Denmark, France, Hungary, Israel, Italy, Latvia, Slovakia, United Kingdom

Regulatory

• FDA-regulated drug study