NCT03223714

Conbercept Ophthalmic Injection for Patients of Central Retinal Vein Occlusion

An Efficacy and Safety Trial of Intravitreal Injection of Conbercept Ophthalmic Injection in Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Chengdu Kanghong Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy and safety of Conbercept ophthalmic injection. This is a multi-center, randomized, double-masked, placebo-controlled phase III clinical study. 237 patients with central retinal vein occlusion(CRVO) are expected to be enrolled in the study and randomly assigned into the Conbercept ophthalmic injection treatment group or the control group at a ratio of 2:1.

Detailed description

The trial is divided into core and extension periods. 1. Core period (Day 0 - Month 5): Eligible subjects after the screening are assigned into the group to receive either intravitreal injection of Conbercept ophthalmic injection at a dose of 0.5 mg (treatment group) or a sham injection (control group) into their study eyes every month (Day 0 - Month 5). At month 6, primary endpoint are judged by investigators. 2. Extension period (Month 6 \~ 12): Subjects in treatment group are reviewed monthly, if he/she meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11). Subjects in control group receive a single intravitreal injection of 0.5 mg Conbercept ophthalmic injection in month 6, followed monthly review, if he/she meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11). The final evaluation is performed at the end of Month 12.

Conditions

• Macular Edema
• Central Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Conbercept Ophthalmic Injection	Subject receive 0.5 mg Conbercept injection into their study eyes every month (Day 0 - Month 5). If subjects meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11).
DRUG	sham injection	Subjects receive sham injection into their study eyes every month (Day 0 - Month 5). Subjects receive a single intravitreal injection of 0.5 mg Conbercept ophthalmic injection in month 6, followed monthly review, if he/she meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11).

Timeline

• Start date: 2016-05-24
• Primary completion: 2020-04-13
• Completion: 2020-09-28
• First posted: 2017-07-21
• Last updated: 2022-07-13

Locations

27 sites across 1 country: China