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Trial record 2 of 2 for:    PANDA | Neovascular Age-related Macular Degeneration

Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular Age-related Macular Degeneration (PANDA-1)

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ClinicalTrials.gov Identifier: NCT03577899
Recruitment Status : Recruiting
First Posted : July 5, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 13, 2018
First Posted Date  ICMJE July 5, 2018
Last Update Posted Date October 10, 2018
Actual Study Start Date  ICMJE September 25, 2018
Estimated Primary Completion Date October 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2018)
  • Proportion of subjects maintaining vision (i.e., losing <15 ETDRS BCVA letters) from baseline to Week 36 [ Time Frame: Baseline to Week 36 ]
  • Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36 [ Time Frame: Baseline to Week 36 ]
  • Mean change from baseline in central retinal thickness (µm) by spectral domain optical coherence tomography (SD-OCT) at Week 36 [ Time Frame: Baseline and Week 36 ]
  • Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48 [ Time Frame: Baseline to Week 48 ]
  • Mean change from baseline in ETDRS BCVA letter score at Week 96 [ Time Frame: Baseline and Week 96 ]
  • Number of participants with adverse events as measure of safety and tolerability [ Time Frame: Baseline to Week 96 ]
  • Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible [ Time Frame: Baseline to Week 96 ]
  • Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible [ Time Frame: Baseline to Week 96 ]
  • Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible [ Time Frame: Baseline to Week 96 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular Age-related Macular Degeneration (PANDA-1)
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-related Macular Degeneration
Intervention  ICMJE
  • 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) 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) 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) for a total of 92 weeks of treatment in the study eye.
    Other Name: Eylea®
Study Arms  ICMJE
  • Experimental: 0.5 mg Conbercept
    Intervention: Biological: 0.5 mg Conbercept Intravitreal Injection
  • Experimental: 1.0 mg Conbercept
    Intervention: Biological: 1.0 mg Conbercept Intravitreal Injection
  • Active Comparator: Aflibercept
    Intervention: Biological: 2.0 mg Aflibercept Intravitreal Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 24, 2018)
1140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 29, 2022
Estimated Primary Completion Date October 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yan Cheng, MD, PhD +1 862 781 6160 panda@cnkh.com
Contact: KH916 Project Office +86 (028)83198965 panda@cnkh.com
Listed Location Countries  ICMJE Colombia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03577899
Other Study ID Numbers  ICMJE KHB-1801
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Chengdu Kanghong Biotech Co., Ltd.
Study Sponsor  ICMJE Chengdu Kanghong Biotech Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yan Cheng, MD, PhD Chengdu Kanghong Biotechnology Co.,Ltd.
PRS Account Chengdu Kanghong Biotech Co., Ltd.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP