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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03577899




Registration number
NCT03577899
Ethics application status
Date submitted
13/06/2018
Date registered
5/07/2018

Titles & IDs
Public title
Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-1)
Scientific 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)
Secondary ID [1] 0 0
KHB-1801
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 0.5 mg Conbercept Intravitreal Injection
Treatment: Other - 1.0 mg Conbercept Intravitreal Injection
Treatment: Other - 2.0 mg Aflibercept Intravitreal Injection

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) for a total of 92 weeks treatment in the study eye.

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) 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) for a total of 92 weeks of treatment in the study eye.


Treatment: Other: 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) for a total of 92 weeks treatment in the study eye.

Treatment: Other: 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) for a total of 92 weeks treatment in the study eye.

Treatment: Other: 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) for a total of 92 weeks of treatment in the study eye.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change from baseline in best corrected visual acuity (BCVA) at Week 36 in the study eye
Timepoint [1] 0 0
Baseline to Week 36
Secondary outcome [1] 0 0
Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36
Timepoint [1] 0 0
Baseline to Week 36
Secondary outcome [2] 0 0
Proportion of subjects gaining =15 ETDRS BCVA letters from baseline to Week 36
Timepoint [2] 0 0
Baseline to Week 36
Secondary outcome [3] 0 0
Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week 36
Timepoint [3] 0 0
Baseline and Week 36
Secondary outcome [4] 0 0
Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48
Timepoint [4] 0 0
Baseline to Week 48
Secondary outcome [5] 0 0
Mean change from baseline in ETDRS BCVA letter score at Week 96
Timepoint [5] 0 0
Baseline and Week 96
Secondary outcome [6] 0 0
Number of participants with adverse events as measure of safety and tolerability
Timepoint [6] 0 0
Baseline to Week 96
Secondary outcome [7] 0 0
Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible
Timepoint [7] 0 0
Baseline to Week 96
Secondary outcome [8] 0 0
Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible
Timepoint [8] 0 0
Baseline to Week 96
Secondary outcome [9] 0 0
Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible
Timepoint [9] 0 0
Baseline to Week 96

Eligibility
Key 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).
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/05/2021
Sample size
Target
Accrual to date
Final
1157
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Kanghong Investigative Site - Albury
Recruitment hospital [2] 0 0
Kanghong Investigative Site - Liverpool
Recruitment hospital [3] 0 0
Kanghong Investigative Site - Parramatta
Recruitment hospital [4] 0 0
Kanghong Investigative Site - Strathfield
Recruitment hospital [5] 0 0
Kanghong Investigative Site - Sydney
Recruitment hospital [6] 0 0
Kanghong Investigative Site - Adelaide
Recruitment hospital [7] 0 0
Kanghong Investigative Site - Glen Waverley
Recruitment hospital [8] 0 0
Kanghong Investigative Site - Melbourne
Recruitment hospital [9] 0 0
Kanghong Investigative Site - Crawley
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2150 - Parramatta
Recruitment postcode(s) [4] 0 0
2135 - Strathfield
Recruitment postcode(s) [5] 0 0
2000 - Sydney
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3150 - Glen Waverley
Recruitment postcode(s) [8] 0 0
3002 - Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Crawley
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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California
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Colorado
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Florida
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United States of America
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Hawaii
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Illinois
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Kansas
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Kentucky
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Mendoza
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Hessen
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Klagenfurt am Wörthersee
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Linz
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Madrid
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Pamplona
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Sant Cugat Del Vallès
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Valencia
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Valladolid
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Zaragoza
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Switzerland
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Canton De Vaud
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Switzerland
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Bern
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Switzerland
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Zürich
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Taiwan
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Changhua City
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Taiwan
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Taipei City
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Taiwan
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Taipei city
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Taiwan
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Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Chengdu Kanghong Biotech Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yan Cheng, MD, PhD
Address 0 0
Chengdu Kanghong Biotechnology Co.,Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03577899