Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-1)

June 23, 2021 updated by: Chengdu Kanghong Biotech Co., Ltd.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5000AAJ
        • Kanghong Investigative Site
      • Mendoza, Argentina, M5500GGK
        • Kanghong Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1120AAN
        • Kanghong Investigative Site
      • Caba, Buenos Aires, Argentina, C1015ABO
        • Kanghong Investigative Site
      • Caba, Buenos Aires, Argentina, C1023AAQ
        • Kanghong Investigative Site
    • Cordoba
      • Córdoba, Cordoba, Argentina, X5000IIT
        • Kanghong Investigative Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000AZH
        • Kanghong Investigative Site
  • Australia
      • Crawley, Australia, 6009
        • Kanghong Investigative Site
      • Sydney, Australia, 2000
        • Kanghong Investigative Site
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Kanghong Investigative Site
      • Liverpool, New South Wales, Australia, 2170
        • Kanghong Investigative Site
      • Parramatta, New South Wales, Australia, 2150
        • Kanghong Investigative Site
      • Strathfield, New South Wales, Australia, 2135
        • Kanghong Investigative Site
      • Sydney, New South Wales, Australia, 2000
        • Kanghong Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Kanghong Investigative Site
    • Victoria
      • Glen Waverley, Victoria, Australia, 3150
        • Kanghong Investigative Site
      • Melbourne, Victoria, Australia, 3002
        • Kanghong Investigative Site
  • Austria
      • Klagenfurt am Wörthersee, Austria, 9020
        • Kanghong Investigative Site
      • Linz, Austria, 4021
        • Kanghong Investigative Site in Linz
      • Linz, Austria, 4021
        • Kanghong Investigative Site
      • Vienna, Austria, 1090
        • Kanghong Investigative Site
      • Vienna, Austria, 1130
        • Kanghong Investigative Site
    • Hessen
      • Feldkirch, Hessen, Austria, 6800
        • Kanghong Investigative Site
  • Belgium
      • Laeken, Belgium, 1020
        • Kanghong Investigative Site
      • Leuven, Belgium, B-3000
        • Kanghong Investigative Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 0C8
        • Kanghong Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
        • Kanghong Ivestigative Site
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Kanghong Investigative Site
      • Mississauga, Ontario, Canada, L4W 1W9
        • Kanghong Investigative Site
      • Toronto, Ontario, Canada, M3C 0G9
        • Kanghong Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H4P 2S4
        • Kanghong Investigative Site
      • Montréal, Quebec, Canada, H4A 3S5
        • Kanghong Investigative Site
      • Sherbrooke, Quebec, Canada, J1G 2V4
        • Kanghong Investigative Site
  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 7500000
        • Kanghong Investigative Site
      • Santiago, Region Metropolitana, Chile, 7560994
        • Kanghong Investigative Site
  • Colombia
      • Cali, Colombia, 760042
        • Kanghong Investigative Site
      • Medellin, Colombia, 50016
        • Kanghong Investigative Site
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080001
        • Kanghong Investigative Site
    • Bogota
      • Bogotá, Bogota, Colombia, 110121
        • Kanghong Investigative Site
  • Germany
      • Bonn, Germany, 53127
        • Kanghong Investigative Site
      • Darmstadt, Germany, 64283
        • Kanghong Investigative Site
      • Düsseldorf, Germany, 40549
        • Kanghong Investigative Site
      • Frankfurt am Main, Germany, 60590
        • Kanghong Investigative Site
      • Freiburg, Germany, 79106
        • Kanghong Investigative Site
      • Göttingen, Germany, 37075
        • Kanghong Investigative Site
      • Hannover, Germany, 30625
        • Kanghong Investigative Site
      • Heidelberg, Germany, 69120
        • Kanghong Investigative Site
      • Homburg, Germany, 66421
        • Kanghong Investigative Site
      • Köln, Germany, D-50937
        • Kanghong Investigative Site
      • Leipzig, Germany, 4103
        • Kanghong Investigative Site
      • Ludwigshafen, Germany, 67063
        • Kanghong Investigative Site
      • Mainz, Germany, 55131
        • Kanghong Investigative Site
      • Marburg, Germany, 35043
        • Kanghong Investigative Site
      • Muenster, Germany, 48149
        • Kanghong Investigative Site
      • München, Germany, 81675
        • Kanghong Investigative Site
      • Regensburg, Germany, 93053
        • Kanghong Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Kanghong Investigative Site in Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Kanghong Investigative Site
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • Kanghong Investigative Site
      • Vilnius, Lithuania, LT-08661
        • Kanghong Investigative Site
  • Mexico
    • Guadalajara
      • Jalisco, Guadalajara, Mexico, 44689
        • Kanghong Investigative Site
      • Jalisco, Guadalajara, Mexico, 45116
        • Kanghong Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Kanghong Investigative Site
      • Tilburg, Netherlands, 5022GC
        • Kanghong Investigative Site
    • Zuid Holland
      • Rotterdam, Zuid Holland, Netherlands, 3011 BH
        • Kanghong Investigative Site
  • New Zealand
      • Auckland, New Zealand, 1149
        • Kanghong Investigative Site
  • Peru
      • Lima, Peru, 0000
        • Kanghong Investigative Site
      • Lima, Peru, 15036
        • Kanghong Investigative Site
      • Lima, Peru, 15036
        • Kanghong Investigator Site
      • Lima, Peru, 15073
        • Kanghong Investigative Site
  • Philippines
    • Manila
      • Makati, Manila, Philippines, 1209
        • Kanghong Investigative Site
      • Pasig City, Manila, Philippines, 1600
        • Kanghong Investigative Site
      • Quezon City, Manila, Philippines, 1112
        • Kanghong Investigative Site
  • Poland
      • Gdansk, Poland, 80-809
        • Kanghong Investigative Site
      • Lodz, Poland, 91-134
        • Kanghong Investigative Site
      • Lodz, Poland, 93-357
        • Kanghong Investigative Site
      • Lublin, Poland, Woj. Lubelskie 20-079
        • Kanghong Investigative Site
      • Olsztyn, Poland, 10-424
        • Kanghong Investigative Site
      • Wroclaw, Poland, 50-556
        • Kanghong Investigative Site
    • Lesser
      • Kraków, Lesser, Poland, 31-501
        • Kanghong Investigative Site
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Kanghong Investigative Site
      • Coimbra, Portugal, 3000-548
        • Kanghong Investigative Site
      • Coimbra, Portugal, 3030-163
        • Kanghong Investigative Site
      • Lisbon, Portugal, 1050-085
        • Kanghong Investigative Site
      • Lisbon, Portugal, 1649-035
        • Kanghong Investigative Site
    • Lisboa
      • Vila Franca de Xira, Lisboa, Portugal, 2600-009
        • Kanghong Investigative Site
  • Singapore
      • Singapore, Singapore, 119074
        • Kanghong Investigative Site
  • Spain
      • Barcelona, Spain, 08021
        • Kanghong Investigative Site
      • Barcelona, Spain, 08028
        • Kanghong Investigative Site
      • Barcelona, Spain, 08035
        • Kanghong Investigative Site
      • Barcelona, Spain, 8024
        • Kanghong Investigatvie Site
      • Bilbao, Spain, 48006
        • Kanghong Investigative Site
      • Madrid, Spain, 28035
        • Kanghong Investigative Site
      • Madrid, Spain, 28040
        • Kanghong Investigative Site
      • Majadahonda, Spain, 28222
        • Kanghong Investigative Site
      • Oviedo, Spain, 33012
        • Kanghong Investigative Site
      • Pamplona, Spain, 31008
        • Kanghong Investigative Site
      • Sant Cugat Del Vallès, Spain, 08195
        • Kanghong Investigative Site
      • Santiago De Compostela, Spain, 15706
        • Kanghong Investigative Site
      • Valencia, Spain, 46014
        • Kanghong Investigative Site
      • Valencia, Spain, 46015
        • Kanghong Investigative Site
      • Valladolid, Spain, 47012
        • Kanghong Investigative Site
      • Zaragoza, Spain, 50009
        • Kanghong Investigative Site in Zaragoza
      • Zaragoza, Spain, 50009
        • Kanghong Investigative Site
    • Andalucia
      • Sevilla, Andalucia, Spain, 41009
        • Kanghong Investigative Site
    • Cataluna
      • Barcelona, Cataluna, Spain, 08907
        • Kanghong Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Kanghong Investigative Site
      • Bern, Switzerland, 3012
        • Kanghong Investigative Site
      • Zürich, Switzerland, 8063
        • Kanghong Investigative Site
      • Zürich, Switzerland, 8091
        • Kanghong Investigative Site
    • Canton De Vaud
      • Lausanne, Canton De Vaud, Switzerland, 1000
        • Kanghong Investigative Site
  • Taiwan
      • Changhua City, Taiwan, 500
        • Kanghong Investigative Site
      • Taipei City, Taiwan, 10002
        • Kanghong Investigative Site
      • Taipei City, Taiwan, 111
        • Kanghong Investigative Site
      • Taipei city, Taiwan, 11217
        • Kanghong Investigative Site
      • Taoyuan, Taiwan, 333
        • Kanghong Investigative Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Kanghong Investigative Site
      • Tucson, Arizona, United States, 85704
        • Kanghong Investigative Site
    • California
      • Beverly Hills, California, United States, 90211-1841
        • Kanghong Investigative Site
      • Campbell, California, United States, 95008
        • Kanghong Investigative Site
      • Fullerton, California, United States, 92835
        • Kanghong Investigative Site
      • Glendale, California, United States, 91203
        • Kanghong Investigative Site
      • La Jolla, California, United States, 92093
        • Kanghong Investigative Site
      • Mountain View, California, United States, 94040
        • Kanghong Investigative Site
      • Oakland, California, United States, 94609
        • Kanghong Investigative Site
      • Palm Desert, California, United States, 92211
        • Kanghong Investigative Site
      • Palm Desert, California, United States, 92260
        • Kanghong Investigative Site
      • Sacramento, California, United States, 95825
        • Kanghong Investigative Site
      • Walnut Creek, California, United States, 94598
        • Kanghong Investigative Site
    • Colorado
      • Golden, Colorado, United States, 80401
        • Kanghong Investigative Site
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Kanghong Investigative Site
      • Fort Myers, Florida, United States, 33912
        • Kanghong Investigative Site
      • Jacksonville, Florida, United States, 32224
        • Kanghong Investigative Site
      • Lakeland, Florida, United States, 33805
        • Kanghong Investigative Site
      • Ocala, Florida, United States, 34474
        • Kanghong Investigative Site
      • Orlando, Florida, United States, 32806
        • Kanghong Investigative Site
      • Plantation, Florida, United States, 33324
        • Kanghong Investigative Site
      • Saint Petersburg, Florida, United States, 33711
        • Kanghong Investigative Site
      • Sarasota, Florida, United States, 34239
        • Kanghong Investigative Site
      • Tampa, Florida, United States, 33617
        • Kanghong Investigative Site
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Kanghong Investigative Site
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Kanghong Investigative Site
      • Chicago, Illinois, United States, 60612
        • Kanghong Investigative Site
      • Lemont, Illinois, United States, 60439-2915
        • Kanghong Investigative Site
    • Kansas
      • Wichita, Kansas, United States, 67226-3443
        • Kanghong Investigative Site
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Kanghong Investigative Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Kanghong Investigative Site in MD
      • Hagerstown, Maryland, United States, 21740
        • Kanghong Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Kanghong Investigative Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Kanghong Investigative Site
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Kanghong Investigator Site
    • New York
      • Albany, New York, United States, 12206
        • Kanghong Investigative Site
      • Hauppauge, New York, United States, 11788
        • Kanghong Investigative Site
      • Rochester, New York, United States, 14620-4655
        • Kanghong Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Kanghong Investigative Site
      • Cleveland, Ohio, United States, 44122-7344
        • Kanghong Investigative Site
      • Cleveland, Ohio, United States, 44195
        • Kanghong Investigative Site
      • Dublin, Ohio, United States, 43016
        • Kanghong Investigative Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Kanghong Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Kanghong Investigative Site
      • West Mifflin, Pennsylvania, United States, 15122-2474
        • Kanghong Investigative Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203-5601
        • Kanghong Investigative Site
    • Texas
      • Abilene, Texas, United States, 79606-1224
        • Kanghong Investigative Site
      • Katy, Texas, United States, 77494
        • Kanghong Investigative Site
      • San Antonio, Texas, United States, 78215
        • Kanghong Investigative Site
      • San Antonio, Texas, United States, 78240-1502
        • Kanghong Investigative Site
      • San Antonio, Texas, United States, 78240
        • Kanghong Investigative Site in TX
      • San Antonio, Texas, United States, 78240
        • Kanghong Investigative Site
      • San Antonio, Texas, United States, 78251
        • Kanghong Investigative Site
      • Southlake, Texas, United States, 76902
        • Kanghong Investigator Site
      • The Woodlands, Texas, United States, 77384
        • Kanghong Investigative Site
      • Tyler, Texas, United States, 75701
        • Kanghong Investigative Site
      • Willow Park, Texas, United States, 76087
        • Kanghong Investigative Site
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Kanghong Investigative Site
      • Norfolk, Virginia, United States, 23502
        • Kanghong Investigative Site
      • Warrenton, Virginia, United States, 20186
        • Kanghong Investigative Site
    • Washington
      • Silverdale, Washington, United States, 98383
        • Kanghong Investigative Site
      • Spokane, Washington, United States, 99204
        • Kanghong Investigative Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Kanghong Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
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: 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
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.
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 Names:
  • Eylea®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to Week 36

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline to Week 36
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
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
To assess mean change from baseline in central retinal thickness (µm) by spectral
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
To assess proportion of subjects maintaining vision (i.e. losing <15 ETDRS BCVA letters) from baseline to Week 48
Baseline to Week 48
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
Baseline and Week 96
Number of participants with adverse events as measure of safety and tolerability
Time Frame: Baseline to Week 96
To assess the number of participants with adverse events as measure of safety and tolerability
Baseline to Week 96
Blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible
Time Frame: Baseline to Week 96
To assess the blood concentration of conbercept doses conducted in a subgroup of subjects, when feasible
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
To assess half-life (t1/2) of conbercept doses conducted in a subgroup of subjects, when feasible
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
To assess the presence of anti-drug antibody of conbercept doses conducted in a subgroup of subjects, when feasible
Baseline to Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chengdu Kanghong Biotech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yan Cheng, MD, PhD, Chengdu Kanghong Biotechnology Co.,Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KHB-1801

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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