Clinical trial NCT03577899: Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-1)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-05
Enrollment: 1157
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye
timeFrame: Baseline to Week 36
Secondary outcomes:
measure: Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36
timeFrame: Baseline to Week 36
measure: Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36
timeFrame: Baseline to Week 36
measure: Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week 36
timeFrame: Baseline and Week 36
measure: Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48
timeFrame: Baseline to Week 48
measure: Mean change from baseline in ETDRS BCVA letter score at Week 96
timeFrame: Baseline and Week 96
measure: Number of participants with adverse events as measure of safety and tolerability
timeFrame: Baseline to Week 96
measure: Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible
timeFrame: Baseline to Week 96
measure: Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible
timeFrame: Baseline to Week 96
measure: Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible
timeFrame: Baseline to Week 96
Other outcomes:
Locations:
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facility: Kanghong Investigative Site
state: Arizona
city: Tucson
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facility: Kanghong Investigative Site
state: Arizona
city: Beverly Hills
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facility: Kanghong Investigative Site
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city: Campbell
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facility: Kanghong Investigative Site
state: California
city: Fullerton
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facility: Kanghong Investigative Site
state: California
city: Glendale
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facility: Kanghong Investigative Site
state: California
city: La Jolla
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facility: Kanghong Investigative Site
state: California
city: Mountain View
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facility: Kanghong Investigative Site
state: California
city: Oakland
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facility: Kanghong Investigative Site
state: California
city: Palm Desert
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facility: Kanghong Investigative Site
state: California
city: Palm Desert
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facility: Kanghong Investigative Site
state: California
city: Sacramento
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facility: Kanghong Investigative Site
state: California
city: Walnut Creek
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facility: Kanghong Investigative Site
state: California
city: Golden
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facility: Kanghong Investigative Site
state: Colorado
city: Fort Myers
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facility: Kanghong Investigative Site
state: Florida
city: Fort Myers
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facility: Kanghong Investigative Site
state: Florida
city: Jacksonville
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facility: Kanghong Investigative Site
state: Florida
city: Lakeland
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facility: Kanghong Investigative Site
state: Florida
city: Ocala
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facility: Kanghong Investigative Site
state: Florida
city: Orlando
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facility: Kanghong Investigative Site
state: Florida
city: Plantation
country: United States
facility: Kanghong Investigative Site
state: Florida
city: Saint Petersburg
country: United States
facility: Kanghong Investigative Site
state: Florida
city: Sarasota
country: United States
facility: Kanghong Investigative Site
state: Florida
city: Tampa
country: United States
facility: Kanghong Investigative Site
state: Florida
city: 'Aiea
country: United States
facility: Kanghong Investigative Site
state: Hawaii
city: Bloomington
country: United States
facility: Kanghong Investigative Site
state: Illinois
city: Chicago
country: United States
facility: Kanghong Investigative Site
state: Illinois
city: Lemont
country: United States
facility: Kanghong Investigative Site
state: Illinois
city: Wichita
country: United States
facility: Kanghong Investigative Site
state: Kansas
city: Paducah
country: United States
facility: Kanghong Investigative Site
state: Kentucky
city: Hagerstown
country: United States
facility: Kanghong Investigative Site in MD
state: Maryland
city: Hagerstown
country: United States
facility: Kanghong Investigative Site
state: Maryland
city: Boston
country: United States
facility: Kanghong Investigative Site
state: Massachusetts
city: Detroit
country: United States
facility: Kanghong Investigative Site
state: Michigan
city: Bloomfield
country: United States
facility: Kanghong Investigator Site
state: New Jersey
city: Albany
country: United States
facility: Kanghong Investigative Site
state: New York
city: Hauppauge
country: United States
facility: Kanghong Investigative Site
state: New York
city: Rochester
country: United States
facility: Kanghong Investigative Site
state: New York
city: Cincinnati
country: United States
facility: Kanghong Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Kanghong Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Kanghong Investigative Site
state: Ohio
city: Dublin
country: United States
facility: Kanghong Investigative Site
state: Ohio
city: Eugene
country: United States
facility: Kanghong Investigative Site
state: Oregon
city: Philadelphia
country: United States
facility: Kanghong Investigative Site
state: Pennsylvania
city: West Mifflin
country: United States
facility: Kanghong Investigative Site
state: Pennsylvania
city: Nashville
country: United States
facility: Kanghong Investigative Site
state: Tennessee
city: Abilene
country: United States
facility: Kanghong Investigative Site
state: Texas
city: Katy
country: United States
facility: Kanghong Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Kanghong Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Kanghong Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Kanghong Investigative Site in TX
state: Texas
city: San Antonio
country: United States
facility: Kanghong Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Kanghong Investigative Site
state: Texas
city: Southlake
country: United States
facility: Kanghong Investigator Site
state: Texas
city: The Woodlands
country: United States
facility: Kanghong Investigative Site
state: Texas
city: Tyler
country: United States
facility: Kanghong Investigative Site
state: Texas
city: Willow Park
country: United States
facility: Kanghong Investigative Site
state: Texas
city: Lynchburg
country: United States
facility: Kanghong Investigative Site
state: Virginia
city: Norfolk
country: United States
facility: Kanghong Investigative Site
state: Virginia
city: Warrenton
country: United States
facility: Kanghong Investigative Site
state: Virginia
city: Silverdale
country: United States
facility: Kanghong Investigative Site
state: Washington
city: Spokane
country: United States
facility: Kanghong Investigative Site
state: Washington
city: Morgantown
country: United States
facility: Kanghong Investigative Site
state: West Virginia
city: Caba
country: Argentina
facility: Kanghong Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Kanghong Investigative Site
state: Buenos Aires
city: Caba
country: Argentina
facility: Kanghong Investigative Site
state: Buenos Aires
city: Córdoba
country: Argentina
facility: Kanghong Investigative Site
state: Cordoba
city: Rosario
country: Argentina
facility: Kanghong Investigative Site
state: Santa Fe
city: Cordoba
country: Argentina
facility: Kanghong Investigative Site
city: Mendoza
country: Argentina
facility: Kanghong Investigative Site
city: Albury
country: Australia
facility: Kanghong Investigative Site
state: New South Wales
city: Liverpool
country: Australia
facility: Kanghong Investigative Site
state: New South Wales
city: Parramatta
country: Australia
facility: Kanghong Investigative Site
state: New South Wales
city: Strathfield
country: Australia
facility: Kanghong Investigative Site
state: New South Wales
city: Sydney
country: Australia
facility: Kanghong Investigative Site
state: New South Wales
city: Adelaide
country: Australia
facility: Kanghong Investigative Site
state: South Australia
city: Glen Waverley
country: Australia
facility: Kanghong Investigative Site
state: Victoria
city: Melbourne
country: Australia
facility: Kanghong Investigative Site
state: Victoria
city: Crawley
country: Australia
facility: Kanghong Investigative Site
city: Sydney
country: Australia
facility: Kanghong Investigative Site
city: Feldkirch
country: Austria
facility: Kanghong Investigative Site
state: Hessen
city: Klagenfurt am Wörthersee
country: Austria
facility: Kanghong Investigative Site
city: Linz
country: Austria
facility: Kanghong Investigative Site in Linz
city: Linz
country: Austria
facility: Kanghong Investigative Site
city: Vienna
country: Austria
facility: Kanghong Investigative Site
city: Vienna
country: Austria
facility: Kanghong Investigative Site
city: Laeken
country: Belgium
facility: Kanghong Investigative Site
city: Leuven
country: Belgium
facility: Kanghong Investigative Site
city: Calgary
country: Canada
facility: Kanghong Investigative Site
state: Alberta
city: Vancouver
country: Canada
facility: Kanghong Ivestigative Site
state: British Columbia
city: London
country: Canada
facility: Kanghong Investigative Site
state: Ontario
city: Mississauga
country: Canada
facility: Kanghong Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Kanghong Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Kanghong Investigative Site
state: Quebec
city: Montréal
country: Canada
facility: Kanghong Investigative Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Kanghong Investigative Site
state: Quebec
city: Santiago
country: Chile
facility: Kanghong Investigative Site
state: Region Metropolitana
city: Santiago
country: Chile
facility: Kanghong Investigative Site
state: Region Metropolitana
city: Barranquilla
country: Colombia
facility: Kanghong Investigative Site
state: Atlantico
city: Bogotá
country: Colombia
facility: Kanghong Investigative Site
state: Bogota
city: Cali
country: Colombia
facility: Kanghong Investigative Site
city: Medellin
country: Colombia
facility: Kanghong Investigative Site
city: Bonn
country: Germany
facility: Kanghong Investigative Site
city: Darmstadt
country: Germany
facility: Kanghong Investigative Site
city: Düsseldorf
country: Germany
facility: Kanghong Investigative Site
city: Frankfurt am Main
country: Germany
facility: Kanghong Investigative Site
city: Freiburg
country: Germany
facility: Kanghong Investigative Site
city: Göttingen
country: Germany
facility: Kanghong Investigative Site
city: Hannover
country: Germany
facility: Kanghong Investigative Site
city: Heidelberg
country: Germany
facility: Kanghong Investigative Site
city: Homburg
country: Germany
facility: Kanghong Investigative Site
city: Köln
country: Germany
facility: Kanghong Investigative Site
city: Leipzig
country: Germany
facility: Kanghong Investigative Site
city: Ludwigshafen
country: Germany
facility: Kanghong Investigative Site
city: Mainz
country: Germany
facility: Kanghong Investigative Site
city: Marburg
country: Germany
facility: Kanghong Investigative Site
city: Muenster
country: Germany
facility: Kanghong Investigative Site
city: München
country: Germany
facility: Kanghong Investigative Site
city: Regensburg
country: Germany
facility: Kanghong Investigative Site
city: Hong Kong
country: Hong Kong
facility: Kanghong Investigative Site in Hong Kong
city: Hong Kong
country: Hong Kong
facility: Kanghong Investigative Site
city: Kaunas
country: Lithuania
facility: Kanghong Investigative Site
city: Vilnius
country: Lithuania
facility: Kanghong Investigative Site
city: Jalisco
country: Mexico
facility: Kanghong Investigative Site
state: Guadalajara
city: Jalisco
country: Mexico
facility: Kanghong Investigative Site
state: Guadalajara
city: Rotterdam
country: Netherlands
facility: Kanghong Investigative Site
state: Zuid Holland
city: Amsterdam
country: Netherlands
facility: Kanghong Investigative Site
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country: Netherlands
facility: Kanghong Investigative Site
city: Auckland
country: New Zealand
facility: Kanghong Investigative Site
city: Lima
country: Peru
facility: Kanghong Investigative Site
city: Lima
country: Peru
facility: Kanghong Investigative Site
city: Lima
country: Peru
facility: Kanghong Investigator Site
city: Lima
country: Peru
facility: Kanghong Investigative Site
city: Makati
country: Philippines
facility: Kanghong Investigative Site
state: Manila
city: Pasig City
country: Philippines
facility: Kanghong Investigative Site
state: Manila
city: Quezon City
country: Philippines
facility: Kanghong Investigative Site
state: Manila
city: Kraków
country: Poland
facility: Kanghong Investigative Site
state: Lesser
city: Gdansk
country: Poland
facility: Kanghong Investigative Site
city: Lodz
country: Poland
facility: Kanghong Investigative Site
city: Lodz
country: Poland
facility: Kanghong Investigative Site
city: Lublin
country: Poland
facility: Kanghong Investigative Site
city: Olsztyn
country: Poland
facility: Kanghong Investigative Site
city: Wroclaw
country: Poland
facility: Kanghong Investigative Site
city: Vila Franca de Xira
country: Portugal
facility: Kanghong Investigative Site
state: Lisboa
city: Coimbra
country: Portugal
facility: Kanghong Investigative Site
city: Coimbra
country: Portugal
facility: Kanghong Investigative Site
city: Coimbra
country: Portugal
facility: Kanghong Investigative Site
city: Lisbon
country: Portugal
facility: Kanghong Investigative Site
city: Lisbon
country: Portugal
facility: Kanghong Investigative Site
city: Singapore
country: Singapore
facility: Kanghong Investigative Site
city: Sevilla
country: Spain
facility: Kanghong Investigative Site
state: Andalucia
city: Barcelona
country: Spain
facility: Kanghong Investigative Site
state: Cataluna
city: Barcelona
country: Spain
facility: Kanghong Investigative Site
city: Barcelona
country: Spain
facility: Kanghong Investigative Site
city: Barcelona
country: Spain
facility: Kanghong Investigative Site
city: Barcelona
country: Spain
facility: Kanghong Investigatvie Site
city: Bilbao
country: Spain
facility: Kanghong Investigative Site
city: Madrid
country: Spain
facility: Kanghong Investigative Site
city: Madrid
country: Spain
facility: Kanghong Investigative Site
city: Majadahonda
country: Spain
facility: Kanghong Investigative Site
city: Oviedo
country: Spain
facility: Kanghong Investigative Site
city: Pamplona
country: Spain
facility: Kanghong Investigative Site
city: Sant Cugat Del Vallès
country: Spain
facility: Kanghong Investigative Site
city: Santiago De Compostela
country: Spain
facility: Kanghong Investigative Site
city: Valencia
country: Spain
facility: Kanghong Investigative Site
city: Valencia
country: Spain
facility: Kanghong Investigative Site
city: Valladolid
country: Spain
facility: Kanghong Investigative Site
city: Zaragoza
country: Spain
facility: Kanghong Investigative Site in Zaragoza
city: Zaragoza
country: Spain
facility: Kanghong Investigative Site
city: Lausanne
country: Switzerland
facility: Kanghong Investigative Site
state: Canton De Vaud
city: Bern
country: Switzerland
facility: Kanghong Investigative Site
city: Bern
country: Switzerland
facility: Kanghong Investigative Site
city: Zürich
country: Switzerland
facility: Kanghong Investigative Site
city: Zürich
country: Switzerland
facility: Kanghong Investigative Site
city: Changhua City
country: Taiwan
facility: Kanghong Investigative Site
city: Taipei City
country: Taiwan
facility: Kanghong Investigative Site
city: Taipei City
country: Taiwan
facility: Kanghong Investigative Site
city: Taipei city
country: Taiwan
facility: Kanghong Investigative Site
city: Taoyuan
country: Taiwan
facility: Kanghong Investigative Site
Study officials:
affiliation: Chengdu Kanghong Biotechnology Co.,Ltd.
name: Yan Cheng, MD, PhD
role: STUDY_DIRECTOR
References: