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Diabetic Macular EdemaPhase 3NCT02194634

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

A Phase 3 study testing Conbercept and Laser in people with Diabetic Macular Edema, run by Chengdu Kanghong Biotech Co., Ltd. at 17 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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) . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Conbercept and Laser
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
248 participants
Where
17 sitesChina
Study dates
Jul 2014to Sep 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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).

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

17 sites in 1 country.

Xun Xu, professor contact

86-21-63240090

17 sites in 1 country

China17 sites, 16 recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Completed

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100083

    Yuling Liu, professor

    Recruiting

  • Beijing Tongren hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100730

    Feng Zhang, professor

    Recruiting

  • Peking Union Medical College Hospital

    Beijing, 100730

    Junjie Ye, professor

    Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Junjun Zhang, professor

    Recruiting

  • Southwest Hospital

    Chongqing, Chongqing Municipality, 400038

    Shaojun Chen, professor

    Recruiting

  • Daping Hospital, Research Institute of Surgery Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

    Jian Ye, professor

    Recruiting

  • Zhongshan Ophthalmic Center , Sun Yat-Sen University

    Guangzhou, Guangdong, 510060

    Xiao ling Liang, professor

    Not yet recruiting

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, 200080

    Xun Xu, professor

    Kun Liu, doctor

    Recruiting

  • Renji hospital shanghai jiaotong university school of medcine

    Shanghai, Shanghai Municipality

    Lin Liu

    Recruiting

  • He eye hospital

    Shenyang, Liaoning, 110034

    Wei He, Doctor

    Recruiting

  • Eye center of Tianjin mendical university

    Tianjin, Tianjin Municipality, 300070

    Zhi qing Li

    Recruiting

  • The Affiliated Eye Hospital of WMC

    Wenzhou, Zhejiang, 325027

    Xiaoling Liu, professor

    Recruiting

  • Wuhan General Hospital of Guangzhou Military

    Wuhan, Hubei, 430070

    Yanping Song, professor

    Recruiting

  • Wuxi No.2 People's Hospital

    Wuxi, Jiangsu, 214002

    Zhifeng Wu, professor

    Recruiting

  • Xijing Hospital

    Xian, Shanxi, 710032

    Yusheng Wang, professor

    Recruiting

  • Eye hospital of Henan province

    Zhengzhou, Henan, 450003

    Ke Fan

    Recruiting

Other trials in China

About this study

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) .

Being tested
Conbercept, Sham injection, Laser, Sham laser

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ConberceptDrug

    Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.

  • Sham injectionOther

    Sham intravitreal injection at first month, then repeated as needed.

  • LaserProcedure or surgery

    Laser treatment at first month, then repeated as needed.

  • Sham laserOther

    Sham laser at first month, then repeated as needed.

Study groups in NCT02194634
Study groupRoleWhat they receive
Conbercept treatment groupExperimentalConbercept 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.
Receives: Drug: Conbercept; Other: Sham laser
Laser treatment groupActive comparatorLaser 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.
Receives: Other: Sham injection; Procedure: Laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and month 12

Secondary outcomes (2)

  1. 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.

    Measured: Baseline and month 12

  2. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2016 (estimated)
  4. Study completionSep 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
248 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02194634
Sponsor's protocol ID
KHSWKH902010
Status last verified
Jun 2015
First submitted
14 Jul 2014
Last updated
6 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34001667

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Conbercept and Laser in people with Diabetic Macular Edema, run by Chengdu Kanghong Biotech Co., Ltd. at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xun Xu, professor (86-21-63240090), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline in best corrected visual acuity (BCVA) at month 12 (time frame: Baseline and month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02194634, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.

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