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

NCT03630952 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1157

Last updated 2021-06-23

No results posted yet for this study

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.

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

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.

Sponsors & Collaborators

  • Chengdu Kanghong Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yan Cheng, MD, PhD · Chengdu Kanghong Biotechnology Co.,Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-21
Primary Completion
2020-09-10
Completion
2021-05-19
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • China
  • Czechia
  • Denmark
  • France
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Slovakia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03630952 on ClinicalTrials.gov