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Intravitreal Conbercept After Vitrectomy

Primary Purpose

Early Proliferative Diabetic Retinopathy

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Conbercept
Sponsored by
Tianjin Medical University Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early Proliferative Diabetic Retinopathy

Eligibility Criteria

28 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. We enrolled 50 eyes from 50 patients that were affected by VH as a consequence of early active PDR.
  2. Patients with non-clearing VH and fibrocellular proliferation without TRD who underwent PPV at Tianjin Medical University Eye Hospital were included in the study.

Exclusion Criteria:

  1. A history of previous PPV;
  2. Severe intraoperative complications
  3. Postoperative silicone oil tamponade;
  4. Menstruation;
  5. Stroke, a thromboembolic event, or myocardial infarction in the previous
  6. months contraindicating the withdrawal of anti-platelet and anti-coagulant medications.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Conbercept

    control group

    Arm Description

    intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery

    Pars plana vitrectomy alone

    Outcomes

    Primary Outcome Measures

    best corrected visual acuity
    BCVA using a Landolt C acuity chart method

    Secondary Outcome Measures

    postoperative complications
    postoperative complications
    central retinal thickness
    Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, one-dimensional images

    Full Information

    First Posted
    January 26, 2018
    Last Updated
    April 29, 2019
    Sponsor
    Tianjin Medical University Eye Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03426540
    Brief Title
    Intravitreal Conbercept After Vitrectomy
    Official Title
    Safety and Efficacy of Intravitreal Conbercept Injection After Vitrectomy for the Treatment of Early Proliferative Diabetic Retinopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    March 30, 2018 (Actual)
    Study Completion Date
    February 28, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tianjin Medical University Eye Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early-stage proliferative diabetic retinopathy (PDR). Hypothesis: intravitreal conbercept therapy may promote functional and anatomic recovery from PDR. intravitreal conbercept therapy may be a useful and safe method for improving visual outcomes of surgery for early-stage PDR.
    Detailed Description
    The drug conbercept (an anti-vascular endothelial growth factors) was recently made available for management of early prolific diabetic retinopathy, but its safety and efficacy still require study. Therefore, the aim is to evaluate the safety and efficacy of intravitreal conbercept after vitrectomy for the management of early proliferative diabetic retinopathy.The patients were randomly assigned (25 eyes each group) to either treatment group and control after they provided informed consent. The treatment group received intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group did not. At the time of study enrollment, physical examinations, best-corrected visual acuity (BCVA), intraocular pressure and central retinal thickness will be measured and fundoscopy be performed. The patients are going to be followed up for at least 6 months via BCVA measurement, fundoscopy, OCT, physical examinations and postoperative complications

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Early Proliferative Diabetic Retinopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conbercept
    Arm Type
    Experimental
    Arm Description
    intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Pars plana vitrectomy alone
    Intervention Type
    Drug
    Intervention Name(s)
    Conbercept
    Intervention Description
    Three-port 25-G PPV was performed in all patients using a Constellation system. Patients in the treatment group received an intravitreal injection of conbercept (10 mg/mL, 0.5 mg) using a sterile technique after 25-G vitrectomy.
    Primary Outcome Measure Information:
    Title
    best corrected visual acuity
    Description
    BCVA using a Landolt C acuity chart method
    Time Frame
    baseline to 24 weeks post-surgery
    Secondary Outcome Measure Information:
    Title
    postoperative complications
    Description
    postoperative complications
    Time Frame
    baseline to 24 weeks post-surgery
    Title
    central retinal thickness
    Description
    Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, one-dimensional images
    Time Frame
    baseline to 24 weeks post-surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    28 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: We enrolled 50 eyes from 50 patients that were affected by VH as a consequence of early active PDR. Patients with non-clearing VH and fibrocellular proliferation without TRD who underwent PPV at Tianjin Medical University Eye Hospital were included in the study. Exclusion Criteria: A history of previous PPV; Severe intraoperative complications Postoperative silicone oil tamponade; Menstruation; Stroke, a thromboembolic event, or myocardial infarction in the previous months contraindicating the withdrawal of anti-platelet and anti-coagulant medications.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rong X Li, MD,PhD
    Organizational Affiliation
    Tianjin Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intravitreal Conbercept After Vitrectomy

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