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

NCT03577899 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: KHB-1801
• Study Type: interventional
• Target: 1,157
• Locations: 21 countries
• Sites: 169

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.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline to Week 36

Secondary Outcomes (9)

• Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36

  Baseline to Week 36

• Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36

  Baseline to Week 36

• 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

• Mean change from baseline in ETDRS BCVA letter score at Week 96

  Baseline and Week 96

Study Arms (3)

0.5 mg Conbercept

EXPERIMENTAL

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.

Biological: 0.5 mg Conbercept Intravitreal Injection

1.0 mg Conbercept

EXPERIMENTAL

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.

Biological: 1.0 mg Conbercept Intravitreal Injection

Aflibercept

ACTIVE COMPARATOR

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.

Biological: 2.0 mg Aflibercept Intravitreal Injection

Interventions

0.5 mg Conbercept Intravitreal Injection BIOLOGICAL

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.

0.5 mg Conbercept

1.0 mg Conbercept Intravitreal Injection BIOLOGICAL

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.

1.0 mg Conbercept

2.0 mg Aflibercept Intravitreal Injection BIOLOGICAL

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.

Also known as: Eylea®

Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead

Study Sites (179)

Kanghong Investigative Site

Phoenix, Arizona, 85053, United States

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Kanghong Investigative Site

Tucson, Arizona, 85704, United States

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Kanghong Investigative Site

Beverly Hills, California, 90211-1841, United States

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Kanghong Investigative Site

Campbell, California, 95008, United States

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Kanghong Investigative Site

Fullerton, California, 92835, United States

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Kanghong Investigative Site

Glendale, California, 91203, United States

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Kanghong Investigative Site

La Jolla, California, 92093, United States

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Kanghong Investigative Site

Mountain View, California, 94040, United States

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Kanghong Investigative Site

Oakland, California, 94609, United States

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Kanghong Investigative Site

Palm Desert, California, 92211, United States

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Kanghong Investigative Site

Palm Desert, California, 92260, United States

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Kanghong Investigative Site

Sacramento, California, 95825, United States

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Kanghong Investigative Site

Walnut Creek, California, 94598, United States

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Kanghong Investigative Site

Golden, Colorado, 80401, United States

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Kanghong Investigative Site

Fort Myers, Florida, 33907, United States

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Kanghong Investigative Site

Fort Myers, Florida, 33912, United States

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Kanghong Investigative Site

Jacksonville, Florida, 32224, United States

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Kanghong Investigative Site

Lakeland, Florida, 33805, United States

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Kanghong Investigative Site

Ocala, Florida, 34474, United States

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Orlando, Florida, 32806, United States

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Plantation, Florida, 33324, United States

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Sarasota, Florida, 34239, United States

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Kanghong Investigative Site

St. Petersburg, Florida, 33711, United States

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Kanghong Investigative Site

Tampa, Florida, 33617, United States

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Kanghong Investigative Site

‘Aiea, Hawaii, 96701, United States

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Bloomington, Illinois, 61704, United States

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Kanghong Investigative Site

Chicago, Illinois, 60612, United States

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Lemont, Illinois, 60439-2915, United States

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Wichita, Kansas, 67226-3443, United States

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Paducah, Kentucky, 42001, United States

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Kanghong Investigative Site in MD

Hagerstown, Maryland, 21740, United States

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Hagerstown, Maryland, 21740, United States

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Boston, Massachusetts, 02114, United States

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Detroit, Michigan, 48202, United States

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Kanghong Investigator Site

Bloomfield, New Jersey, 07003, United States

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Albany, New York, 12206, United States

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Hauppauge, New York, 11788, United States

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Rochester, New York, 14620-4655, United States

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Cincinnati, Ohio, 45242, United States

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Cleveland, Ohio, 44122-7344, United States

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Cleveland, Ohio, 44195, United States

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Dublin, Ohio, 43016, United States

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Eugene, Oregon, 97401, United States

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Philadelphia, Pennsylvania, 19107, United States

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West Mifflin, Pennsylvania, 15122-2474, United States

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Nashville, Tennessee, 37203-5601, United States

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Abilene, Texas, 79606-1224, United States

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Katy, Texas, 77494, United States

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San Antonio, Texas, 78215, United States

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San Antonio, Texas, 78240-1502, United States

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Kanghong Investigative Site in TX

San Antonio, Texas, 78240, United States

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San Antonio, Texas, 78240, United States

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San Antonio, Texas, 78251, United States

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Kanghong Investigator Site

Southlake, Texas, 76902, United States

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The Woodlands, Texas, 77384, United States

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Tyler, Texas, 75701, United States

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Willow Park, Texas, 76087, United States

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Lynchburg, Virginia, 24502, United States

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Norfolk, Virginia, 23502, United States

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Warrenton, Virginia, 20186, United States

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Silverdale, Washington, 98383, United States

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Spokane, Washington, 99204, United States

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Morgantown, West Virginia, 26506, United States

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CABA, Buenos Aires, 1120AAN, Argentina

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CABA, Buenos Aires, C1015ABO, Argentina

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CABA, Buenos Aires, C1023AAQ, Argentina

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Córdoba, Córdoba Province, X5000IIT, Argentina

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Rosario, Santa Fe Province, S2000AZH, Argentina

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Córdoba, X5000AAJ, Argentina

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Mendoza, M5500GGK, Argentina

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Albury, New South Wales, 2640, Australia

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Liverpool, New South Wales, 2170, Australia

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Parramatta, New South Wales, 2150, Australia

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Strathfield, New South Wales, 2135, Australia

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Sydney, New South Wales, 2000, Australia

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Adelaide, South Australia, 5000, Australia

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Glen Waverley, Victoria, 3150, Australia

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Melbourne, Victoria, 3002, Australia

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Crawley, 6009, Australia

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Sydney, 2000, Australia

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Kanghong Investigative Site

Feldkirch, Hessen, 6800, Austria

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Kanghong Investigative Site

Klagenfurt, 9020, Austria

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Kanghong Investigative Site in Linz

Linz, 4021, Austria

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Kanghong Investigative Site

Linz, 4021, Austria

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Vienna, 1090, Austria

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Vienna, 1130, Austria

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Kanghong Investigative Site

Laken, 1020, Belgium

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Kanghong Investigative Site

Leuven, B-3000, Belgium

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Kanghong Investigative Site

Calgary, Alberta, T2H 0C8, Canada

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Kanghong Ivestigative Site

Vancouver, British Columbia, V5Z 3N9, Canada

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London, Ontario, N6A 4G5, Canada

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Mississauga, Ontario, L4W 1W9, Canada

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Toronto, Ontario, M3C 0G9, Canada

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Montreal, Quebec, H4A 3S5, Canada

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Montreal, Quebec, H4P 2S4, Canada

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Sherbrooke, Quebec, J1G 2V4, Canada

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Santiago, Santiago Metropolitan, 7500000, Chile

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Santiago, Santiago Metropolitan, 7560994, Chile

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Barranquilla, Atlántico, 080001, Colombia

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Bogotá, Bogota D.C., 110121, Colombia

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Kanghong Investigative Site

Cali, 760042, Colombia

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Kanghong Investigative Site

Medellín, 50016, Colombia

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Kanghong Investigative Site

Bonn, 53127, Germany

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Cologne, D-50937, Germany

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Darmstadt, 64283, Germany

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Kanghong Investigative Site

Düsseldorf, 40549, Germany

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Frankfurt am Main, 60590, Germany

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Freiburg im Breisgau, 79106, Germany

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Göttingen, 37075, Germany

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Kanghong Investigative Site

Homburg, 66421, Germany

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Leipzig, 4103, Germany

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Kanghong Investigative Site

Ludwigshafen, 67063, Germany

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Kanghong Investigative Site

Mainz, 55131, Germany

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Marburg, 35043, Germany

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Kanghong Investigative Site

München, 81675, Germany

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Kanghong Investigative Site

Münster, 48149, Germany

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Kanghong Investigative Site

Regensburg, 93053, Germany

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Kanghong Investigative Site in Hong Kong

Hong Kong, 999077, Hong Kong

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Kanghong Investigative Site

Hong Kong, 999077, Hong Kong

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Kanghong Investigative Site

Kaunas, LT-50161, Lithuania

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Kanghong Investigative Site

Vilnius, LT-08661, Lithuania

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Kanghong Investigative Site

Jalisco, Guadalajara, 44689, Mexico

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Kanghong Investigative Site

Jalisco, Guadalajara, 45116, Mexico

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Rotterdam, South Holland, 3011 BH, Netherlands

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Amsterdam, 1105 AZ, Netherlands

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Tilburg, 5022GC, Netherlands

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Auckland, 1149, New Zealand

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Lima, 0000, Peru

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Kanghong Investigative Site

Lima, 15036, Peru

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Kanghong Investigator Site

Lima, 15036, Peru

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Kanghong Investigative Site

Lima, 15073, Peru

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Kanghong Investigative Site

Makati, Manila, 1209, Philippines

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Kanghong Investigative Site

Pasig, Manila, 1600, Philippines

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Kanghong Investigative Site

Quezon City, Manila, 1112, Philippines

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Kanghong Investigative Site

Krakow, Lesser, 31-501, Poland

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Gdansk, 80-809, Poland

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Lodz, 91-134, Poland

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Kanghong Investigative Site

Lodz, 93-357, Poland

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Lublin, Woj. Lubelskie 20-079, Poland

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Olsztyn, 10-424, Poland

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Kanghong Investigative Site

Wroclaw, 50-556, Poland

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Vila Franca de Xira, Lisbon District, 2600-009, Portugal

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Kanghong Investigative Site

Coimbra, 3000-075, Portugal

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Kanghong Investigative Site

Coimbra, 3000-548, Portugal

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Kanghong Investigative Site

Coimbra, 3030-163, Portugal

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Kanghong Investigative Site

Lisbon, 1050-085, Portugal

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Kanghong Investigative Site

Lisbon, 1649-035, Portugal

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Kanghong Investigative Site

Singapore, 119074, Singapore

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Kanghong Investigative Site

Seville, Andalusia, 41009, Spain

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Kanghong Investigative Site

Barcelona, Catalonia, 08907, Spain

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Kanghong Investigative Site

Barcelona, 08021, Spain

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Kanghong Investigative Site

Barcelona, 08028, Spain

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Kanghong Investigative Site

Barcelona, 08035, Spain

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Kanghong Investigatvie Site

Barcelona, 8024, Spain

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Kanghong Investigative Site

Bilbao, 48006, Spain

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Kanghong Investigative Site

Madrid, 28035, Spain

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Kanghong Investigative Site

Madrid, 28040, Spain

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Kanghong Investigative Site

Majadahonda, 28222, Spain

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Kanghong Investigative Site

Oviedo, 33012, Spain

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Kanghong Investigative Site

Pamplona, 31008, Spain

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Kanghong Investigative Site

Sant Cugat del Vallès, 08195, Spain

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Kanghong Investigative Site

Santiago de Compostela, 15706, Spain

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Kanghong Investigative Site

Valencia, 46014, Spain

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Kanghong Investigative Site

Valencia, 46015, Spain

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Kanghong Investigative Site

Valladolid, 47012, Spain

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Kanghong Investigative Site in Zaragoza

Zaragoza, 50009, Spain

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Kanghong Investigative Site

Zaragoza, 50009, Spain

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Kanghong Investigative Site

Lausanne, Canton of Vaud, 1000, Switzerland

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Kanghong Investigative Site

Bern, 3010, Switzerland

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Kanghong Investigative Site

Bern, 3012, Switzerland

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Kanghong Investigative Site

Zurich, 8063, Switzerland

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Kanghong Investigative Site

Zurich, 8091, Switzerland

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Kanghong Investigative Site

Changhua, 500, Taiwan

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Kanghong Investigative Site

Taipei, 10002, Taiwan

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Kanghong Investigative Site

Taipei, 111, Taiwan

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Kanghong Investigative Site

Taipei, 11217, Taiwan

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Kanghong Investigative Site

Taoyuan District, 333, Taiwan

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MeSH Terms

Interventions

KH902 fusion protein; aflibercept

Study Officials

• Yan Cheng, MD, PhD

  Chengdu Kanghong Biotechnology Co.,Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 5, 2018
• Study Start: September 25, 2018
• Primary Completion: September 25, 2020
• Study Completion: May 19, 2021
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); CA (8); CL (2); BE (2); NL (3); ME (2); PL (7); CO (4); PT (6); SG (1); AU (6); AR (7); TW (5); DE (17); CH (5); ES (19); HK (2); PE (4); US (63); LI (2); PH (3)