We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    panda chengdu
Previous Study | Return to List | Next Study

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:
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co., Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Phase
Neovascular Age-related Macular Degeneration Biological: 0.5 mg Conbercept Intravitreal Injection Biological: 1.0 mg Conbercept Intravitreal Injection Biological: 2.0 mg Aflibercept Intravitreal Injection Phase 3

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 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
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


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
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 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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:

  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 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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 Show 154 study locations
Sponsors and Collaborators
Chengdu Kanghong Biotech Co., Ltd.
Investigators
Layout table for investigator information
Study Director: Yan Cheng, MD, PhD Chengdu Kanghong Biotechnology Co.,Ltd.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Chengdu Kanghong Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03630952    
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents