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

Primary Purpose

Diabetic Macular Edema

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Conbercept
Sham injection
Laser
Sham laser
Sponsored by
Chengdu Kanghong Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University People's Hospital
  • Peking University Third HospitalRecruiting
  • Beijing Tongren hospital affiliated to Capital Medical UniversityRecruiting
  • Southwest HospitalRecruiting
  • Daping Hospital, Research Institute of Surgery Third Military Medical UniversityRecruiting
  • Zhongshan Ophthalmic Center , Sun Yat-Sen University
  • Eye hospital of Henan provinceRecruiting
  • Wuhan General Hospital of Guangzhou MilitaryRecruiting
  • Wuxi No.2 People's HospitalRecruiting
  • He eye hospitalRecruiting
  • Shanghai First People's HospitalRecruiting
  • Renji hospital shanghai jiaotong university school of medcineRecruiting
  • Xijing HospitalRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Eye center of Tianjin mendical universityRecruiting
  • The Affiliated Eye Hospital of WMCRecruiting
  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conbercept treatment group

Laser treatment group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean change from baseline in best corrected visual acuity (BCVA) at month 12
To compare mean change from baseline BCVA between treatment group and controlled group at month 12.

Secondary Outcome Measures

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

Full Information

First Posted
July 14, 2014
Last Updated
January 5, 2016
Sponsor
Chengdu Kanghong Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02194634
Brief Title
Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu Kanghong Biotech Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conbercept treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Laser treatment group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Conbercept
Intervention Description
Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.
Intervention Type
Other
Intervention Name(s)
Sham injection
Intervention Description
Sham intravitreal injection at first month, then repeated as needed.
Intervention Type
Procedure
Intervention Name(s)
Laser
Intervention Description
Laser treatment at first month, then repeated as needed.
Intervention Type
Other
Intervention Name(s)
Sham laser
Intervention Description
Sham laser at first month, then repeated as needed.
Primary Outcome Measure Information:
Title
Mean change from baseline in best corrected visual acuity (BCVA) at month 12
Description
To compare mean change from baseline BCVA between treatment group and controlled group at month 12.
Time Frame
Baseline and month 12
Secondary Outcome Measure Information:
Title
Mean change from baseline in central retinal thickness (CRT) between two groups
Description
To compare mean change from baseline CRT between two groups at month 12.
Time Frame
Baseline and month 12
Title
Safety (e.g. incidence of adverse events) of Conbercept ophthalmic injection
Description
To assess safety parameters during the study, such as incidence of adverse events , incidence of adverse drug reactions etc.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
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
Title
Mean change from baseline BCVA between treatment group and controlled group
Time Frame
Baseline and every month, up to 12 months
Title
Change from baseline in visual acuity distribution of treatment group and controlled group
Time Frame
Month 6, month 12
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients sign informed consent, and are willing and able to comply with all the follow-ups; Age ≥ 18 years , both genders; Diagnosis of type 1 or type 2 diabetes mellitus; Serum HbA1c ≤ 10%; 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. Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320). Exclusion Criteria: Active infectious ocular inflammation in either eye; Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR; Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy; Iris neovascularization in the study eye; Uncontrolled glaucoma, or history of glaucoma surgery; Aphakia in the study eye; History of vitrectomy in the study eye; 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; Liver, kidney dysfunction; History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xun Xu, professor
Phone
86-21-63240090
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Completed
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100083
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuling Liu, professor
Facility Name
Beijing Tongren hospital affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Zhang, professor
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaojun Chen, professor
Facility Name
Daping Hospital, Research Institute of Surgery Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Ye, professor
Facility Name
Zhongshan Ophthalmic Center , Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao ling Liang, professor
Facility Name
Eye hospital of Henan province
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke Fan
Facility Name
Wuhan General Hospital of Guangzhou Military
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanping Song, professor
Facility Name
Wuxi No.2 People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhifeng Wu, professor
Facility Name
He eye hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei He, Doctor
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xun Xu, professor
First Name & Middle Initial & Last Name & Degree
Kun Liu, doctor
Facility Name
Renji hospital shanghai jiaotong university school of medcine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Liu
Facility Name
Xijing Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yusheng Wang, professor
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junjun Zhang, professor
Facility Name
Eye center of Tianjin mendical university
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi qing Li
Facility Name
The Affiliated Eye Hospital of WMC
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoling Liu, professor
Facility Name
Peking Union Medical College Hospital
City
Bei jing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junjie Ye, professor

12. IPD Sharing Statement

Citations:
PubMed Identifier
34001667
Citation
Liu K, Wang H, He W, Ye J, Song Y, Wang Y, Liu X, Wu Z, Chen S, Fan K, Liu Y, Zhang F, Li Z, Liu L, Zhang J, Zhang X, Ye J, Liang X, Li X, Ke X, Wu Q, Li J, Tao S, Wang X, Rosenfeld P, Heier JS, Kaiser P, Xu X. Intravitreal conbercept for diabetic macular oedema: 2-year results from a randomised controlled trial and open-label extension study. Br J Ophthalmol. 2022 Oct;106(10):1436-1443. doi: 10.1136/bjophthalmol-2020-318690. Epub 2021 May 17.
Results Reference
derived

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

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