Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02194634
Recruitment Status : Unknown
Verified June 2015 by Chengdu Kanghong Biotech Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 18, 2014
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co., Ltd.

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) .

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Conbercept Other: Sham injection Procedure: Laser Other: Sham laser Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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 ]
  2. Mean change from baseline BCVA between treatment group and controlled group [ Time Frame: Baseline and every month, up to 12 months ]
  3. Change from baseline in visual acuity distribution of treatment group and controlled group [ Time Frame: Month 6, month 12 ]
  4. 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 ]


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02194634


Contacts
Layout table for location contacts
Contact: Xun Xu, professor 86-21-63240090

Locations
Show Show 17 study locations
Sponsors and Collaborators
Chengdu Kanghong Biotech Co., Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Chengdu Kanghong Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02194634    
Other Study ID Numbers: KHSWKH902010
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: June 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases