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-1)

Chengdu Kanghong Biotech Co., Ltd.9 sites in 7 countries1,157 target enrollmentSeptember 25, 2018

ConditionsNeovascular Age-related Macular Degeneration

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Neovascular Age-related Macular Degeneration
Sponsor: Chengdu Kanghong Biotech Co., Ltd.
Enrollment: 1157
Locations: 9
Primary Endpoint: Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 25, 2018

End Date

May 19, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Men and women ≥ 50 years of age at the Screening visit;
•Females must be at least 1 year postmenopausal, or surgically sterilized, or, if of childbearing potential, must have a negative pregnancy test at the Screening visit;
•o Women of childbearing potential must agree to use a highly effective method of contraception throughout the study.
•Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and;
•Have active subfoveal choroidal neovascularization (CNV) lesions secondary to AMD (including polypoidal choroidal vasculopathy (PCV)) evidenced by subfoveal fluorescein angiography (FA) leakage, or definite subfoveal fluid by SD-OCT in the study eye at Screening;
•Have a ETDRS BCVA letter score of 78 to 25 in the study eye at Screening;
•Are willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria

•Have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular AMD in the study eye except dietary supplements or vitamins;
•Have participated as a subject in any interventional clinical trial within one month (30 days) prior to Baseline visit;
•Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is under the fovea and is one or more disc areas in size (greater than 2.5 mm2) in the study eye at Screening;
•Have any retinal pigment epithelial tears or rips in the study eye at Screening or upon examination at Baseline;
•Have any vitreous hemorrhage in the study eye upon examination at Baseline or history of vitreous hemorrhage within eight weeks prior to Screening;
•Have any other cause of CNV;
•Have had prior pars plana vitrectomy in the study eye;
•Have presence of a full thickness macular hole at Screening or upon examination at Baseline or a history of a full thickness macular hole in the study eye;
•Have prior trabeculectomy or other filtration surgery in the study eye;
•Have uncontrolled glaucoma;

Outcomes

Primary Outcomes

Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye

Time Frame: Baseline to Week 36

BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method

Secondary Outcomes

Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36(Baseline to Week 36)
Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible(Baseline to Week 96)
Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible(Baseline to Week 96)
Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36(Baseline to Week 36)
Number of participants with adverse events as measure of safety and tolerability(Baseline to Week 96)
Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week 36(Baseline and Week 36)
Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48(Baseline to Week 48)
Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible(Baseline to Week 96)
Mean change from baseline in ETDRS BCVA letter score at Week 96(Baseline and Week 96)