Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular Age-related Macular Degeneration (PANDA-1)



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:10/12/2018
Start Date:September 25, 2018
End Date:January 29, 2022
Contact:Yan Cheng, MD, PhD
Email:panda@cnkh.com
Phone:+1 862 781 6160

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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)

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.

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.

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.
We found this trial at
13
sites
Phoenix, Arizona 85021
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Asheville, North Carolina 28803
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Asheville, NC
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Austin, Texas 78705
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Austin, TX
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Bogotá,
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Boston, Massachusetts 02114
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Boston, MA
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Cleveland, Ohio 44112
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Cleveland, OH
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Grand Rapids, Michigan 94546
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Grand Rapids, MI
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Houston, Texas 77030
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Houston, TX
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Jacksonville, Florida 32224
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Jacksonville, FL
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Long Beach, California 90807
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Long Beach, CA
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Pasadena, California 91105
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Pasadena, CA
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San Antonio, Texas 78240
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San Antonio, TX
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Sarasota, Florida 34329
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Sarasota, FL
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