Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)

January 5, 2016 updated by: Chengdu Kanghong Biotech Co., Ltd.
This study is designed to assess safety and efficacy of intravitreal injection of Conbercept on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
248

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xun Xu, professor
  • Phone Number: 86-21-63240090

Study Locations

  • China
      • Bei jing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Principal Investigator:
          • Junjie Ye, professor
    • Beijing
      • Beijing, Beijing, China, 100083
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Yuling Liu, professor
      • Beijing, Beijing, China, 100044
        • Completed
        • Peking University People's Hospital
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital affiliated to Capital Medical University
        • Principal Investigator:
          • Feng Zhang, Professor
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Southwest Hospital
        • Principal Investigator:
          • Shaojun Chen, professor
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Daping Hospital, Research Institute of Surgery Third Military Medical University
        • Principal Investigator:
          • Jian Ye, professor
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Zhongshan Ophthalmic Center , Sun Yat-Sen University
        • Principal Investigator:
          • Xiao ling Liang, professor
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Eye hospital of Henan province
        • Principal Investigator:
          • Ke Fan
    • Hubei
      • Wuhan, Hubei, China, 430070
        • Recruiting
        • Wuhan General Hospital of Guangzhou Military
        • Principal Investigator:
          • Yanping Song, professor
    • Jiangsu
      • Wuxi, Jiangsu, China, 214002
        • Recruiting
        • Wuxi No.2 People's Hospital
        • Principal Investigator:
          • Zhifeng Wu, professor
    • Liaoning
      • Shenyang, Liaoning, China, 110034
        • Recruiting
        • He Eye Hospital
        • Principal Investigator:
          • Wei He, Doctor
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Recruiting
        • Shanghai First People's Hospital
        • Principal Investigator:
          • Xun Xu, professor
        • Principal Investigator:
          • Kun Liu, doctor
      • Shanghai, Shanghai, China
        • Recruiting
        • Renji hospital shanghai jiaotong university school of medcine
    • Shanxi
      • Xian, Shanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Principal Investigator:
          • Yusheng Wang, professor
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Principal Investigator:
          • Junjun Zhang, professor
    • Tianjin
      • Tianjin, Tianjin, China, 300070
        • Recruiting
        • Eye center of Tianjin mendical university
        • Principal Investigator:
          • Zhi qing Li
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • The Affiliated Eye Hospital of WMC
        • Principal Investigator:
          • Xiaoling Liu, professor

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients sign informed consent, and are willing and able to comply with all the follow-ups;
  2. Age ≥ 18 years , both genders;
  3. Diagnosis of type 1 or type 2 diabetes mellitus;
  4. Serum HbA1c ≤ 10%;

  5. Study eye must meet the following criteria:

    • Visual acuity impairment caused by DME with involving foveal;
    • BCVA score ≥ 24 and ≤ 73 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 4 meter/1 meter of ETDRS test(Equivalent Snellen chart 20/40 to 20/320);
    • Visual impairment due to Choroidal Neovascularization (CNV) secondary to high myopia.
    • Central retinal thickness (CRT) ≥300μm (spectral domain Optical Coherence Tomography (OCT), the CRT measurements must be confirmed by central reading center);
    • Refractive media opacities and miosis have no effect on the fundus examination.
  6. Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320).

Exclusion Criteria:

  1. Active infectious ocular inflammation in either eye;
  2. Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR;
  3. Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy;
  4. Iris neovascularization in the study eye;
  5. Uncontrolled glaucoma, or history of glaucoma surgery;
  6. Aphakia in the study eye;
  7. History of vitrectomy in the study eye;
  8. History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to the screening, or possibly need panretinal photocoagulation of the study eye during the study;
  9. Liver, kidney dysfunction;
  10. History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases.

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: Conbercept treatment group
Conbercept injection and sham laser treatment at day 0 for 1st time, the investigators will decide whether the subjects need to get repeated treatment according to monthly assessment.
Drug: Conbercept
Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.
Other: Sham laser
Sham laser at first month, then repeated as needed.
Active Comparator: Laser treatment group
Laser treatment and sham injection at day 0 for 1st time, the investigators will decide whether the repeated laser treatment is needed according to monthly results during the visit after 3 months.
Other: Sham injection
Sham intravitreal injection at first month, then repeated as needed.
Procedure: Laser
Laser treatment at first month, then repeated as needed.

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 month 12
Time Frame: Baseline and month 12
To compare mean change from baseline BCVA between treatment group and controlled group at month 12.
Baseline and month 12

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
Mean change from baseline in central retinal thickness (CRT) between two groups
Time Frame: Baseline and month 12
To compare mean change from baseline CRT between two groups at month 12.
Baseline and month 12
Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection
Time Frame: 12 months
To assess safety parameters during the study, such as incidence of adverse events , incidence of adverse drug reactions etc.
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Mean changes from baseline of photographic parameters, such as CRT, total macular volume and leakage area etc.
Time Frame: Baseline and every month, up to 12 months
Baseline and every month, up to 12 months
Mean change from baseline BCVA between treatment group and controlled group
Time Frame: Baseline and every month, up to 12 months
Baseline and every month, up to 12 months
Change from baseline in visual acuity distribution of treatment group and controlled group
Time Frame: Month 6, month 12
Month 6, month 12
The 25-item National Eye Institute Visual Function Questionnaire （NEI VFQ-25）total score mean change from baseline of between treatment group and controlled group
Time Frame: Month 6, month 12
Month 6, month 12

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
July 1, 2014

Primary Completion (Anticipated)

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.
December 1, 2016

Study Completion (Anticipated)

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.
September 1, 2017

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).
July 14, 2014

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.
July 16, 2014

First Posted (Estimate)

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 18, 2014

Study Record Updates

Last Update Posted (Estimate)

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.
January 6, 2016

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.
January 5, 2016

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, 2015

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.
  • KHSWKH902010

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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