ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    KHB-1801
Previous Study | Return to List | Next Study

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03577899
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co.,Ltd.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1140 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-1)
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : October 20, 2020
Estimated Study Completion Date : January 29, 2022


Arm Intervention/treatment
Experimental: 0.5 mg Conbercept 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.

Experimental: 1.0 mg Conbercept 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.

Active Comparator: Aflibercept 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®




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 ]
  2. Proportion of subjects gaining ≥15 ETDRS BCVA letters from baseline to Week 36 [ Time Frame: Baseline to Week 36 ]
  3. 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 ]
  4. Proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48 [ Time Frame: Baseline to Week 48 ]
  5. Mean change from baseline in ETDRS BCVA letter score at Week 96 [ Time Frame: Baseline and Week 96 ]
  6. Number of participants with adverse events as measure of safety and tolerability [ Time Frame: Baseline to Week 96 ]
  7. Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible [ Time Frame: Baseline to Week 96 ]
  8. Half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible [ Time Frame: Baseline to Week 96 ]
  9. Presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible [ Time Frame: Baseline to Week 96 ]


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:

  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.

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): NCT03577899


Contacts
Contact: Yan Cheng, MD, PhD +1 862 781 6160 panda@cnkh.com
Contact: KH916 Project Office +86 (028)83198965 panda@cnkh.com

Locations
United States, Arizona
Kanghong Investigative Site Not yet recruiting
Phoenix, Arizona, United States, 85014
United States, California
Kanghong Investigative Site Not yet recruiting
Long Beach, California, United States, 90807
Kanghong Investigative Site Not yet recruiting
Pasadena, California, United States, 91105
United States, Florida
Kanghong Investigative Site Not yet recruiting
Jacksonville, Florida, United States, 32224
Kanghong Investigative Site Not yet recruiting
Sarasota, Florida, United States, 34329
United States, Massachusetts
Kanghong Investigative Site Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Kanghong Investigative Site Not yet recruiting
Grand Rapids, Michigan, United States, 49546
United States, North Carolina
Kanghong Investigative Site Not yet recruiting
Asheville, North Carolina, United States, 28803
United States, Ohio
Kanghong Investigative Site Not yet recruiting
Cleveland, Ohio, United States, 44112
United States, Texas
Kanghong Investigative Site Not yet recruiting
Austin, Texas, United States, 78705
Kanghong Investigative Site Not yet recruiting
Houston, Texas, United States, 77030
Kanghong Investigative Site Not yet recruiting
San Antonio, Texas, United States, 78240
Colombia
Kanghong Investigative Site Not yet recruiting
Bogotá, Colombia, 110421
Sponsors and Collaborators
Chengdu Kanghong Biotech Co.,Ltd.
Investigators
Study Director: Yan Cheng, MD, PhD Chengdu Kanghong Biotechnology Co.,Ltd.

Responsible Party: Chengdu Kanghong Biotech Co.,Ltd.
ClinicalTrials.gov Identifier: NCT03577899     History of Changes
Other Study ID Numbers: KHB-1801
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases