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

Last Updated: 2021-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-25

Study Completion Date

2021-05-19

Brief Summary

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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.

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Detailed Description

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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

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Neovascular Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0.5 mg Conbercept

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) for a total of 92 weeks treatment in the study eye.

Group Type EXPERIMENTAL

0.5 mg Conbercept Intravitreal Injection

Intervention Type BIOLOGICAL

1.0 mg Conbercept

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) for a total of 92 weeks treatment in the study eye.

Group Type EXPERIMENTAL

1.0 mg Conbercept Intravitreal Injection

Intervention Type BIOLOGICAL

Aflibercept

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) for a total of 92 weeks of treatment in the study eye.

Group Type ACTIVE_COMPARATOR

2.0 mg Aflibercept Intravitreal Injection

Intervention Type BIOLOGICAL

Interventions

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0.5 mg Conbercept Intravitreal Injection

Intervention Type BIOLOGICAL

1.0 mg Conbercept Intravitreal Injection

Intervention Type BIOLOGICAL

2.0 mg Aflibercept Intravitreal Injection

Intervention Type BIOLOGICAL

Other Intervention Names

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Eylea®

Eligibility Criteria

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Inclusion Criteria

1. Men and women ≥ 50 years of age at the Screening visit;
2. 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.
3. Have received no previous treatment for neovascular AMD, including laser photocoagulation and/or photodynamic therapy (PDT) and/or IVT VEGF antagonists (treatment naïve) and;
4. 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;
5. Have a ETDRS BCVA letter score of 78 to 25 in the study eye at Screening;
6. Are willing and able to sign the study written informed consent form (ICF).

Exclusion Criteria

1. 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;
2. Have participated as a subject in any interventional clinical trial within one month (30 days) prior to Baseline visit;
3. 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;
4. Have any retinal pigment epithelial tears or rips in the study eye at Screening or upon examination at Baseline;
5. Have any vitreous hemorrhage in the study eye upon examination at Baseline or history of vitreous hemorrhage within eight weeks prior to Screening;
6. Have any other cause of CNV;
7. Have had prior pars plana vitrectomy in the study eye;
8. 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;
9. Have prior trabeculectomy or other filtration surgery in the study eye;
10. Have uncontrolled glaucoma;
11. Have active intraocular inflammation in either eye at Screening or upon examination at Baseline or a history of uveitis in either eye;
12. 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;
13. 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;
14. Have any use of long acting intraocular steroids, including implants, within six months prior to Day 1, Baseline;
15. Have any known allergy to povidone iodine or known serious allergy to the fluorescein sodium for injection in angiography;
16. Any history of known contraindications indicated in the Food and Drug Administration (FDA)-approved label for the active control;
17. If female, be pregnant (positive urine pregnancy test at Screening) or breastfeeding.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Cheng, MD, PhD

Role: STUDY_DIRECTOR

Chengdu Kanghong Biotechnology Co.,Ltd.

Locations

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Kanghong Investigative Site

Phoenix, Arizona, United States

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Kanghong Investigative Site

Tucson, Arizona, United States

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Kanghong Investigative Site

Beverly Hills, California, United States

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Kanghong Investigative Site

Campbell, California, United States

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Kanghong Investigative Site

Fullerton, California, United States

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Kanghong Investigative Site

Glendale, California, United States

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Kanghong Investigative Site

La Jolla, California, United States

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Kanghong Investigative Site

Mountain View, California, United States

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Kanghong Investigative Site

Oakland, California, United States

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Kanghong Investigative Site

Palm Desert, California, United States

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Kanghong Investigative Site

Palm Desert, California, United States

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Kanghong Investigative Site

Sacramento, California, United States

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Kanghong Investigative Site

Walnut Creek, California, United States

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Kanghong Investigative Site

Golden, Colorado, United States

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Kanghong Investigative Site

Fort Myers, Florida, United States

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Kanghong Investigative Site

Fort Myers, Florida, United States

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Kanghong Investigative Site

Jacksonville, Florida, United States

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Kanghong Investigative Site

Lakeland, Florida, United States

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Kanghong Investigative Site

Ocala, Florida, United States

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Kanghong Investigative Site

Orlando, Florida, United States

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Kanghong Investigative Site

Plantation, Florida, United States

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Kanghong Investigative Site

Sarasota, Florida, United States

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Kanghong Investigative Site

St. Petersburg, Florida, United States

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Kanghong Investigative Site

Tampa, Florida, United States

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Kanghong Investigative Site

‘Aiea, Hawaii, United States

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Kanghong Investigative Site

Bloomington, Illinois, United States

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Kanghong Investigative Site

Chicago, Illinois, United States

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Kanghong Investigative Site

Lemont, Illinois, United States

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Kanghong Investigative Site

Wichita, Kansas, United States

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Kanghong Investigative Site

Paducah, Kentucky, United States

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Kanghong Investigative Site in MD

Hagerstown, Maryland, United States

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Kanghong Investigative Site

Hagerstown, Maryland, United States

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Kanghong Investigative Site

Boston, Massachusetts, United States

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Kanghong Investigative Site

Detroit, Michigan, United States

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Kanghong Investigator Site

Bloomfield, New Jersey, United States

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Kanghong Investigative Site

Albany, New York, United States

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Kanghong Investigative Site

Hauppauge, New York, United States

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Kanghong Investigative Site

Rochester, New York, United States

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Kanghong Investigative Site

Cincinnati, Ohio, United States

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Kanghong Investigative Site

Cleveland, Ohio, United States

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Kanghong Investigative Site

Cleveland, Ohio, United States

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Kanghong Investigative Site

Dublin, Ohio, United States

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Kanghong Investigative Site

Eugene, Oregon, United States

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Kanghong Investigative Site

Philadelphia, Pennsylvania, United States

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Kanghong Investigative Site

West Mifflin, Pennsylvania, United States

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Kanghong Investigative Site

Nashville, Tennessee, United States

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Kanghong Investigative Site

Abilene, Texas, United States

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