Study Stopped
desired primary endpoint was not met
Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2)
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-2)
1 other identifier
interventional
1,157
12 countries
154
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2018
154 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
December 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2021
CompletedJune 23, 2021
June 1, 2021
1.7 years
August 11, 2018
June 22, 2021
Conditions
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
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
- +4 more secondary outcomes
Study Arms (3)
0.5 mg Conbercept
EXPERIMENTALSubjects 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) through Week 36. At the Week 40 visit, the criteria-based pro re nata (PRN) approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
1.0 mg Conbercept
EXPERIMENTALSubjects 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) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
Aflibercept
ACTIVE COMPARATORSubjects 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) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
Interventions
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) through Week 36. At the Week 40 visit, the criteria-based pro re nata (PRN) approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
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) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
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) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
Eligibility Criteria
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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (154)
Kanghong Investigative Site
Phoenix, Arizona, 85020, United States
Kanghong Investigative Site
Phoenix, Arizona, 85021, United States
Kanghong Investigative Site
Springdale, Arkansas, 72762, United States
Kanghong Investigative Site
Arcadia, California, 91006, United States
Kanghong Investigative Site
Arcadia, California, 91007, United States
Kanghong Investigative Site
Bakersfield, California, 93309, United States
Kanghong Investigative Site
Encino, California, 91436, United States
Kanghong Investigative Site
Glendale, California, 91203, United States
Kanghong Investigative Site
Glendora, California, 91741, United States
Kanghong Investigative Site
Huntington Beach, California, 92647, United States
Kanghong Investigative Site
Pasadena, California, 91107, United States
Kanghong Investigative Site
Poway, California, 92064, United States
Kanghong Investigative Site
Redlands, California, 92373, United States
Kanghong Investigative Site
Redlands, California, 92374, United States
Kanghong Investigative Site
Riverside, California, 92505, United States
Kanghong Investigative Site
San Francisco, California, 94109, United States
Kanghong Investigative Site
Santa Barbara, California, 93013, United States
Kanghong Investigative Site
Colorado Springs, Colorado, 80909, United States
Kanghong Investigative Site
Waterford, Connecticut, 06385, United States
Kanghong Investigative Site
Boynton Beach, Florida, 33426, United States
Kanghong Investigative Site
Bradenton, Florida, 34209, United States
Kanghong Investigative Site
Miami, Florida, 33126, United States
Kanghong Investigative Site
Miami, Florida, 33143, United States
Kanghong Investigative Site
Stuart, Florida, 34994, United States
Kanghong Investigative Site
Winter Haven, Florida, 33880, United States
Kanghong Investigative Site
Atlanta, Georgia, 30328, United States
Kanghong Investigative Site
Augusta, Georgia, 30909, United States
Kanghong Investigative Site
Marietta, Georgia, 30060, United States
Kanghong Investigative Site
Elmhurst, Illinois, 60126, United States
Kanghong Investigative Site
Indianapolis, Indiana, 46290, United States
Kanghong Investigative Site
New Albany, Indiana, 47150, United States
Kanghong Investigative Site
Leawood, Kansas, 66211, United States
Kanghong Investigative Site
Springfield, Massachusetts, 01107, United States
Kanghong Investigative Site
Grand Rapids, Michigan, 49546, United States
Kanghong Investigative Site
Traverse City, Michigan, 49686, United States
Kanghong Investigative Site
St Louis, Missouri, 63128, United States
Kanghong Investigative Site
Reno, Nevada, 89502, United States
Kanghong Investigative Site
Northfield, New Jersey, 08205, United States
Kanghong Investigative Site
Teaneck, New Jersey, 07666, United States
Kanghong Investigative Site
Albuquerque, New Mexico, 87109, United States
Kanghong Investigative Site
Brooklyn, New York, 11201, United States
Kanghong Investigative Site
Great Neck, New York, 11021, United States
Kanghong Investigative Site
Liverpool, New York, 13088, United States
Kanghong Investigative Site
Shirley, New York, 11967, United States
Kanghong Investigative Site
Asheville, North Carolina, 28803, United States
Kanghong Investigative Site
Winston-Salem, North Carolina, 27157, United States
Kanghong Investigative Site
Youngstown, Ohio, 44505, United States
Kanghong Investigative Site
Oklahoma City, Oklahoma, 73104, United States
Kanghong Investigative Site
Medford, Oregon, 97504, United States
Kanghong Investigative Site
Portland, Oregon, 97225, United States
Kanghong Investigative Site
Springfield, Oregon, 97477, United States
Kanghong Investigative Site
Camp Hill, Pennsylvania, 17011, United States
Kanghong Investigative Site
Kingston, Pennsylvania, 18704, United States
Kanghong Investigative Site
Ladson, South Carolina, 29456, United States
Kanghong Investigative Site
Rapid City, South Dakota, 57701, United States
Kanghong Investigative Site
Arlington, Texas, 76012, United States
Kanghong Investigative Site
Austin, Texas, 78705, United States
Kanghong Investigative Site
Austin, Texas, 78731, United States
Kanghong Investigative Site
Bellaire, Texas, 77401, United States
Kanghong Investigative Site
Dallas, Texas, 75231, United States
Kanghong Investigative Site
Fort Worth, Texas, 76102, United States
Kanghong Investigative Site
Kingwood, Texas, 77339, United States
Kanghong Investigative Site
McAllen, Texas, 78503, United States
Kanghong Investigative Site
Midland, Texas, 79706, United States
Kanghong Investigative Site
Temple, Texas, 76502, United States
Kanghong Investigative Site
Salt Lake City, Utah, 84107, United States
Kanghong Investigative Site
Burlington, Vermont, 05401, United States
Kanghong Investigative Site
Charlottesville, Virginia, 22903, United States
Kanghong Investigative Site
Bellevue, Washington, 98004, United States
Kanghong Investigative Site
Plovdiv, 4003, Bulgaria
Kanghong Investigative Site
Sofia, 1408, Bulgaria
Kanghong Investigative Site
Sofia, 1517, Bulgaria
Kanghong Investigative Site
Varna, 9010, Bulgaria
Kanghong Investigative Site
Beijing, Beijing Municipality, 100044, China
Kanghong Investigative Site
Shanghai, Shanghai Municipality, 200031, China
Kanghong Investigative Site
Shanghai, Shanghai Municipality, 200080, China
Kanghong Investigative Site
Tianjin, Tianjin Municipality, 300384, China
Kanghong Investigative Site
Brno, 625 00, Czechia
Kanghong Investigative Site
Prague, 100 34, Czechia
Kanghong Investigative Site
Prague, 10034, Czechia
Kanghong Investigative Site
Prague, 128 00, Czechia
Kanghong Investigative Site
Prague, 15000, Czechia
Kanghong Investigative Site
Aalborg, 9100, Denmark
Kanghong Investigative Site
Aarhus N, 8200, Denmark
Kanghong Investigative Site
Glostrup Municipality, 2600, Denmark
Kanghong Investigative Site
Roskilde, 4000, Denmark
Kanghong Investigative Site
Sønderborg, 6400, Denmark
Kanghong Investigative Site
Bordeaux, 33000, France
Kanghong Investigative Site
Créteil, 94010, France
Kanghong Investigative Site
Dijon, 21079, France
Kanghong Investigative Site
Marseille, 13008, France
Kanghong Investigative Site
Paris, 75010, France
Kanghong Investigative Site
Paris, 75012, France
Kanghong Investigative Site
Paris, 75015, France
Kanghong Investigative Site
Paris, 75019, France
Kanghong Investigative Site
Poitiers, 86021, France
Kanghong Investigative Site
Saint-Cyr-sur-Loire, 37540, France
Kanghong Investigative Site
Strasbourg, 67000, France
Kanghong Investigative Site
Pécs, Baranya, 7621, Hungary
Kanghong Investigative Site
Szeged, Csongrád megye, 6720, Hungary
Kanghong Investigative Site
Debrecen, Hajdú-Bihar, 4032, Hungary
Kanghong Investigative Site
Budapest, Pest County, 1062, Hungary
Kanghong Investigative Site
Budapest, Pest County, 1076, Hungary
Kanghong Investigative Site
Budapest, Pest County, 1085, Hungary
Kanghong Investigative Site
Budapest, Pest County, 1106, Hungary
Kanghong Investigative Site
Budapest, Pest County, 1133, Hungary
Kanghong Investigative Site
Budapest, Pest County, 1204, Hungary
Kanghong Investigative Site
Zalaegerszeg, Zala County, 8900, Hungary
Kanghong Investigative Site
Ashkelon, Ha'Darom, 7830604, Israel
Kanghong Investigative Site
Beersheba, 8457108, Israel
Kanghong Investigative Site
Haifa, 31048, Israel
Kanghong Investigative Site
Haifa, 31096, Israel
Kanghong Investigative Site
Haifa, 3436212, Israel
Kanghong Investigative Site
Jerusalem, 9103102, Israel
Kanghong Investigative Site
Jerusalem, 9112001, Israel
Kanghong Investigative Site
Kfar Saba, 4428164, Israel
Kanghong Investigative Site
Petah Tikva, 4941492, Israel
Kanghong Investigative Site
Poria – Neve Oved, 1520800, Israel
Kanghong Investigative Site
Rehovot, 76100, Israel
Kanghong Investigative Site
Tel Aviv, 64239, Israel
Kanghong Investigative Site
Zrifin, 7030000, Israel
Kanghong Investigative Site
Chieti, 66100, Italy
Kanghong Investigative Site
Florence, 50134, Italy
Kanghong Investigative Site
Genova, 16132, Italy
Kanghong Investigative Site
Milan, 20122, Italy
Kanghong Investigative Site
Milan, 20132, Italy
Kanghong Investigative Site
Milan, 20157, Italy
Kanghong Investigative Site
Negrar, 37024, Italy
Kanghong Investigative Site
Roma, 00133, Italy
Kanghong Investigative Site
Roma, 00198, Italy
Kanghong Investigative Site
Udine, 33100, Italy
Kanghong Investigative Site
Riga, LV-1002, Latvia
Kanghong Investigative Site
Riga, LV-1006, Latvia
Kanghong Investigative Site
Riga, LV-1009, Latvia
Kanghong Investigative Site
Bratislava, 82606, Slovakia
Kanghong Investigative Site
Trenčín, 91171, Slovakia
Kanghong Investigative Site
Žilina, 010 08, Slovakia
Kanghong Investigative Site
Žilina, 01207, Slovakia
Kanghong Investigative Site
Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom
Kanghong Investigative Site
Southampton, Hampshire, SO16 6YD, United Kingdom
Kanghong Investigative Site
Gorleston-on-Sea, Norfolk, NR31 6LA, United Kingdom
Kanghong Investigative Site
Frimley, Surrey, GU16 7UJ, United Kingdom
Kanghong Investigative Site
Belfast, BT12 6BA, United Kingdom
Kanghong Investigative Site
Bradford, BD9 6RJ, United Kingdom
Kanghong Investigative Site
Bristol, BS1 2LX, United Kingdom
Kanghong Investigative Site
Canterbury, CT1 3NG, United Kingdom
Kanghong Investigative Site
Derby, DE22 3NE, United Kingdom
Kanghong Investigative Site
Gorleston-on-Sea, NR31 6LA, United Kingdom
Kanghong Investigative Site
Leeds, LS9 7TF, United Kingdom
Kanghong Investigative Site
London, EC1V 2PD, United Kingdom
Kanghong Investigative Site
London, NW1 5QH, United Kingdom
Kanghong Investigative Site
London, NW10 7NS, United Kingdom
Kanghong Investigative Site
Sheffield, S10 2JF, United Kingdom
Kanghong Investigative Site
Sunderland, SR2 9HP, United Kingdom
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Yan Cheng, MD, PhD
Chengdu Kanghong Biotechnology Co.,Ltd.
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
August 11, 2018
First Posted
August 15, 2018
Study Start
December 21, 2018
Primary Completion
September 10, 2020
Study Completion
May 19, 2021
Last Updated
June 23, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share