8/2/2021
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`Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2) - Full Text View - ClinicalTrials.gov
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`Trial record 1 of 1 for: NCT03630952
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`Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD
`(PANDA-2)
`
`The safety and scientific validity of this study is the responsibility of the study sponsor
`and investigators. Listing a study does not mean it has been evaluated by the U.S.
`Federal Government. Read our disclaimer for details.
`
`
`ClinicalTrials.gov Identifier: NCT03630952
`
`Recruitment Status  : Terminated (desired primary endpoint was not met)
`First Posted  : August 15, 2018
`Last Update Posted  : June 23, 2021
`
`Sponsor:
`Chengdu Kanghong Biotech Co., Ltd.
`
`Information provided by (Responsible Party):
`Chengdu Kanghong Biotech Co., Ltd.
`
`https://clinicaltrials.gov/ct2/show/NCT03630952?term=NCT03630952&draw=2&rank=1
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`Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2) - Full Text View - ClinicalTrials.gov
`
`Study Details
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`Tabular View
`
`No Results Posted
`
`Disclaimer
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`How to Read a Study Record
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`Study Description
`
`Go to
`
`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.
`
`Condition or disease 
`
`Intervention/treatment 
`
`Neovascular Age-related Macular
`Degeneration
`
`Biological: 0.5 mg Conbercept
`Intravitreal Injection
`
`Phase
`
`
`Phase 3
`
`Biological: 1.0 mg Conbercept
`Intravitreal Injection
`
`Biological: 2.0 mg Aflibercept
`Intravitreal Injection
`
`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.
`
`Study Design
`
`Go to
`
`Study Type  :
`Interventional (Clinical Trial)
`Actual Enrollment  :
`1157 participants
`Allocation:
`Randomized
`Intervention Model:
`Parallel Assignment
`Masking:
`Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
`Primary Purpose:
`Treatment
`
`https://clinicaltrials.gov/ct2/show/NCT03630952?term=NCT03630952&draw=2&rank=1
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`Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2) - Full Text View - ClinicalTrials.gov
`
`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-2)
`Actual Study Start Date  :
`December 21, 2018
`Actual Primary Completion Date  :
`September 10, 2020
`Actual Study Completion Date  :
`May 19, 2021
`
`Resource links provided by the National Library of Medicine
`
`MedlinePlus Genetics related topics: Age-related macular degeneration
`
`MedlinePlus related topics: Macular Degeneration
`
`Drug Information available for: Aflibercept Ziv-aflibercept
`
`Genetic and Rare Diseases Information Center resources: PANDAS
`
`U.S. FDA Resources
`
`Arms and Interventions
`
`Go to
`
`Arm 
`
`Intervention/treatment 
`
`Experimental: 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) 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.
`
`Biological: 0.5 mg Conbercept Intravitreal Injection
`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.
`
`https://clinicaltrials.gov/ct2/show/NCT03630952?term=NCT03630952&draw=2&rank=1
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`Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2) - Full Text View - ClinicalTrials.gov
`
`Arm 
`
`Intervention/treatment 
`
`Experimental: 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) 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.
`
`Biological: 1.0 mg Conbercept Intravitreal Injection
`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.
`
`Active Comparator: 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) 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.
`
`Biological: 2.0 mg Aflibercept Intravitreal Injection
`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.
`Other Name: Eylea®
`
`Outcome Measures
`
`Go to
`
`Primary Outcome Measures  :
`1. Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye
`[ Time Frame: Baseline to Week 36 ]
`
`BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method
`
`Secondary Outcome Measures  :
`1. Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to
`Week 36 [ Time Frame: Baseline to Week 36 ]
`
`To Assess Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from
`baseline to Week 36
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`https://clinicaltrials.gov/ct2/show/NCT03630952?term=NCT03630952&draw=2&rank=1
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`Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2) - Full Text View - ClinicalTrials.gov
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`2. Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36
`[ Time Frame: Baseline to Week 36 ]
`
`To Assess Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36
`
`3. Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence
`tomography (SD-OCT) at Week [ Time Frame: Baseline and Week 36 ]
`
`To Assess Mean change from baseline in central retinal thickness (µm) by spectral domain optical
`coherence tomography (SD-OCT) at Week
`
`4. Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to
`Week 48 [ Time Frame: Baseline to Week 48 ]
`
`To Assess Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from
`baseline to Week 48
`
`5. Mean change from baseline in ETDRS BCVA letter score at Week 96 [ Time Frame: Baseline and
`Week 96 ]
`
`To Assess Mean change from baseline in ETDRS BCVA letter score at Week 96
`
`6. Number of participants with adverse events as measure of safety and tolerability
`[ Time Frame: Baseline to Week 96 ]
`
`To Assess Number of participants with adverse events as measure of safety and tolerability
`
`7. Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible
`[ Time Frame: Baseline to Week 96 ]
`
`To Assess Blood concentration of conbercept doses conducted in a subgroup of subjects, when
`feasible
`
`8. Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible
`[ Time Frame: Baseline to Week 96 ]
`
`To Assess Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible
`
`9. Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when
`feasible [ Time Frame: Baseline to Week 96 ]
`
`To Assess Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects,
`when feasible
`
`https://clinicaltrials.gov/ct2/show/NCT03630952?term=NCT03630952&draw=2&rank=1
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`Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2) - Full Text View - ClinicalTrials.gov
`
`Eligibility Criteria
`
`Go to
`
`Information from the National Library of Medicine
`
`Choosing to participate in a study is an important personal decision. Talk with your doctor and family
`members or friends about deciding to join a study. To learn more about this study, you or your doctor may
`contact the study research staff using the contacts provided below. For general information, Learn About
`Clinical Studies.
`
`Ages Eligible for Study:
`50 Years and older (Adult, Older Adult)
`Sexes Eligible for Study:
`All
`Accepts Healthy Volunteers:
`No
`
`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:
`
`https://clinicaltrials.gov/ct2/show/NCT03630952?term=NCT03630952&draw=2&rank=1
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`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.
`
`Contacts and Locations
`
`Go to
`
`Information from the National Library of Medicine
`
`https://clinicaltrials.gov/ct2/show/NCT03630952?term=NCT03630952&draw=2&rank=1
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`To learn more about this study, you or your doctor may contact the study research staff using the contact
`information provided by the sponsor.
`
`Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630952
`
`Locations
`
` Show 154 study locations
`
`Sponsors and Collaborators
`Chengdu Kanghong Biotech Co., Ltd.
`
`Investigators
`Study Director: Yan Cheng, MD, PhD Chengdu Kanghong Biotechnology Co.,Ltd.
`
`More Information
`
`Go to
`
`Responsible Party:
`Chengdu Kanghong Biotech Co., Ltd.
`ClinicalTrials.gov Identifier:
`NCT03630952 History of Changes
`Other Study ID Numbers:
`KHB-1802
`First Posted:
`August 15, 2018 Key Record Dates
`Last Update Posted:
`June 23, 2021
`Last Verified:
`June 2021
`
`Individual Participant Data (IPD) Sharing Statement:
`Plan to Share IPD:
`No
`
`Studies a U.S. FDA-regulated Drug Product:
`Yes
`
`https://clinicaltrials.gov/ct2/show/NCT03630952?term=NCT03630952&draw=2&rank=1
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`Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2) - Full Text View - ClinicalTrials.gov
`
`Studies a U.S. FDA-regulated Device Product:
`No
`
`Additional relevant MeSH terms:
`Macular Degeneration
`Wet Macular Degeneration
`Retinal Degeneration
`Retinal Diseases
`Eye Diseases
`
`https://clinicaltrials.gov/ct2/show/NCT03630952?term=NCT03630952&draw=2&rank=1
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