Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-1)

Stopped early · Phase 3

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

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.

Key facts

Study ID: NCT03577899
Run by: Chengdu Kanghong Biotech Co., Ltd.
People needed: 1157
Starts: 2018-09-25
Expected to finish: 2021-05-19
Last updated by the study team: 2021-06-24

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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;
Have active intraocular inflammation in either eye at Screening or upon examination at Baseline or a history of uveitis in either eye;
Have aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye;
Significant media opacities, including cataract, in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention during the study period;
Have any use of long acting intraocular steroids, including implants, within six months prior to Day 1, Baseline;
Have any known allergy to povidone iodine or known serious allergy to the fluorescein sodium for injection in angiography;
Any history of known contraindications indicated in the Food and Drug Administration (FDA)-approved label for the active control;
If female, be pregnant (positive urine pregnancy test at Screening) or breastfeeding.

Where it is running

Kanghong Investigative Site — Tucson, Arizona, United States
Kanghong Investigative Site — Beverly Hills, California, United States
Kanghong Investigative Site — Campbell, California, United States
Kanghong Investigative Site — Fullerton, California, United States
Kanghong Investigative Site — Glendale, California, United States
Kanghong Investigative Site — La Jolla, California, United States
Kanghong Investigative Site — Mountain View, California, United States
Kanghong Investigative Site — Oakland, California, United States
Kanghong Investigative Site — Palm Desert, California, United States
Kanghong Investigative Site — Palm Desert, California, United States
Kanghong Investigative Site — Sacramento, California, United States
Kanghong Investigative Site — Walnut Creek, California, United States
Kanghong Investigative Site — Golden, Colorado, United States
Kanghong Investigative Site — Fort Myers, Florida, United States
Kanghong Investigative Site — Fort Myers, Florida, United States
Kanghong Investigative Site — Jacksonville, Florida, United States
Kanghong Investigative Site — Lakeland, Florida, United States
Kanghong Investigative Site — Ocala, Florida, United States
Kanghong Investigative Site — Orlando, Florida, United States
Kanghong Investigative Site — Plantation, Florida, United States
Kanghong Investigative Site — Sarasota, Florida, United States
Kanghong Investigative Site — St. Petersburg, Florida, United States
Kanghong Investigative Site — Tampa, Florida, United States
Kanghong Investigative Site — ‘Aiea, Hawaii, United States
Kanghong Investigative Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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