Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy

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: NCT02816710
Recruitment Status : Completed
First Posted : June 28, 2016
Results First Posted : November 21, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Xi Shen, Ruijin Hospital

Brief Summary:
To evaluate efficacy of different intravitreal Conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Tractional Retinal Detachment Drug: Conbercept Phase 4

Detailed Description:
To assess the clinical effects of preoperative, intraoperative or preoperative combined with intraoperative intravitreal conbercept (IVC) injection in pars plana vitrectomy (PPV) with silicone oil tamponade for severe proliferative diabetic retinopathy (PDR). Methods. These patients were randomly assigned to three groups: Group 1 received an IVC injection 3 to 5 days before surgery; Group 2 received an IVC injection at the end of surgery; and Group 3 received an IVC injection 3 to 5 days before PPV as well as an IVC injection at the end of PPV. Follow-up examinations were performed for at least six months after surgery.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Different Conbercept Injection Methods in Treatment of Severe Proliferative Diabetic Retinopathy
Actual Study Start Date : July 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IVC Preoperative group
Conbercept injection before vitrectomy
Drug: Conbercept
Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.

Experimental: IVC Postoperative group
Conbercept injection at the end of vitrectomy
Drug: Conbercept
Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.

Experimental: IVC Pre- and Post-operative group
First conbercept injection before vitrectomy and second at the end of operation.
Drug: Conbercept
Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.




Primary Outcome Measures :
  1. Best-corrected Visual Acuity [ Time Frame: 6 months ]
  2. Duration of Surgery [ Time Frame: during the operation time ]
    To evaluate the influence of these three methods to the final duration of surgery. We carefully estimated the time of the vitrectomy from insertion to extraction of the 23-gauge three-port trocars.

  3. Intraoperative Bleeding [ Time Frame: Time between the insertion and extraction of three 23-gauge vitrectomy ports ]
    The grading criteria for intraoperative bleeding: Grade 1, spontaneous cessation of minor bleeding or bleeding that stopped by transient elevation of perfusion pressure; Grade 2, moderate bleeding requiring endodiathermy or broad blood clots formed far away from the bleeding site; Grade 3, thick blood clots exceeding half of the posterior pole or affecting the operation field.


Secondary Outcome Measures :
  1. Postoperative Preretinal Blood [ Time Frame: postoperatively, up to 1 week ]
    The grading criteria for postoperative preretinal blood: Grade 1, isolated blood clots within 10 disk area but without covering the posterior pole; Grade 2, broad blood clots exceeding 10 disk area regardless of involvement of the posterior pole; Grade 3, broad blood clots exceeding 10 disk area as well as involving the posterior pole. Maximal extent of preretinal blood within 1 week postoperatively was used for grading the extent of hemorrhage.

  2. Reabsorption Time of Blood [ Time Frame: follow up period, up to an average of 6 months after the operation ]
    To monitor the reabsorption time of preretinal blood.

  3. Recurrent Vitreous Hemorrhage [ Time Frame: follow up period, up to an average of 6 months after the operation ]
    Recurrent vitreous hemorrhage(VH) was referred to any new episode of VH occurring after one week postoperatively, dividing into early stage (≤ 4 weeks) and late stage (> 4 weeks).

  4. Frequency of Intraoperative Electrocoagulation [ Time Frame: during the operation time ]
    The number of times electrocoagulation, which was used to stop bleeding, was carefully counted.

  5. Number of Participants With Neovascular Glaucoma (NVG) [ Time Frame: follow up period, up to an average of 6 months after the operation ]
  6. Recurrent Retinal Detachment [ Time Frame: follow up period, up to an average of 6 months after the operation ]
  7. Need for Reoperation [ Time Frame: follow up period, up to an average of 6 months after the operation ]
    due to recurrent retinal detachment or unclear vitreous hemorrhage



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. Subjects of either sex aged ≥ 18 years.
  2. Diagnosis of diabetes mellitus (type 1 or type 2);
  3. Active proliferative diabetic retinopathy was clinically evident;
  4. Study eyes required a vitrectomy and silicone oil tamponade due to vitreous hemorrhage with significant fibrous proliferation, tractional retinal detachment in the posterior pole or complicated retinal detachment, which can be detected by B-scan ultrasonography.
  5. Ability to give informed consent.

Exclusion Criteria:

  1. Coexistent ocular disease that may interfere with visual outcome;
  2. Prior vitreoretinal surgery or anti-vascular endothelial growth factor (VEGF) pharmacotherapy in either eye;
  3. A macula-involving retinal detachment for >6 months in the study eye;
  4. Iris or angle neovascularization and neovascular glaucoma;
  5. known allergy to any components of conbercept formulation
  6. severe external ocular infection;
  7. pregnancy or current oral contraceptive intake;
  8. usage of anticoagulant or antiplatelet therapy;
  9. preoperative or postoperative poor diabetes control [serum hemoglobin A1c (HbA1c) >11.0%];
  10. uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases;
  11. <6 months of follow-up post initial surgery.

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): NCT02816710


Locations
Layout table for location information
China, Shanghai
Ruijin Hospital
Shanghai, Shanghai, China, 20025
Sponsors and Collaborators
Ruijin Hospital
Investigators
Layout table for investigator information
Study Director: Xi Shen, PhD Shanghai Jiao Tong University School of Medicine
  Study Documents (Full-Text)

Documents provided by Xi Shen, Ruijin Hospital:
Study Protocol  [PDF] June 30, 2016
Statistical Analysis Plan  [PDF] June 30, 2016

Layout table for additonal information
Responsible Party: Xi Shen, chief physician, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02816710    
Other Study ID Numbers: 2016062501
First Posted: June 28, 2016    Key Record Dates
Results First Posted: November 21, 2019
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Xi Shen, Ruijin Hospital:
Conbercept
Proliferative diabetic retinopathy
Silicone oil tamponade
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Diabetic Retinopathy
Retinal Detachment
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases