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Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage

Primary Purpose

Anti-VEGF, Branch Retinal Vein Occlusion, Vitrectomy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
anti-VEGF
fan-shaped photocoagulation
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anti-VEGF

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥ 18 years old;
  2. BRVO is diagnosed
  3. Vitreous hemorrhage
  4. Vitreous hemorrhage combined with mild retinal fibrovascular proliferation (early fibrous vascular membrane, thin fibrous vascular membrane, loose retinal adhesion and intact local retinal structure)

Exclusion Criteria:

  1. BRVO combined with severe retinal fibrovascular proliferation (long-term fibrovascular membrane, thick fibrous vascular membrane and tightly attached to the retina, deformation of local retinal, retinal tear or suspension of retinal vein )
  2. BRVO combined with retinal detachment
  3. Retinal veins are completely whitened
  4. iris neovascularization or neovascular glaucoma
  5. Combined glaucoma
  6. combined with other retinopathy
  7. Received anti-VEGF treatment within 3 months before surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    anti-VEGF

    fan-shaped photocoagulation

    Arm Description

    vitreoretinal surgery combined with intraoperative anti-VEGF

    vitreoretinal surgery combined with fan-shaped photocoagulation

    Outcomes

    Primary Outcome Measures

    Mean change from baseline in best-corrected visual acuity (BCVA)
    Assessed using the ETDRS protocol

    Secondary Outcome Measures

    Mean change from baseline in visual field
    Assessed on Humphery(30-2 and 60-4)
    chang from baseline in structure of retina
    Assessed on Optical Coherence Tomography(OCT)
    chang from baseline in retinal neovascularization
    Assessed on Fundus Fluorescein Angiography(FFA)

    Full Information

    First Posted
    August 15, 2018
    Last Updated
    August 16, 2018
    Sponsor
    Wenzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03637283
    Brief Title
    Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage
    Official Title
    Feasibility Study of Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2018 (Anticipated)
    Primary Completion Date
    December 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wenzhou Medical University

    4. Oversight

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

    5. Study Description

    Brief Summary
    To evaluate the efficacy and safety of Anti-VEGF instead of intraoperative fan-shaped photocoagulation in BRVO combined with vitreous hemorrhage.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anti-VEGF, Branch Retinal Vein Occlusion, Vitrectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    anti-VEGF
    Arm Type
    Experimental
    Arm Description
    vitreoretinal surgery combined with intraoperative anti-VEGF
    Arm Title
    fan-shaped photocoagulation
    Arm Type
    Active Comparator
    Arm Description
    vitreoretinal surgery combined with fan-shaped photocoagulation
    Intervention Type
    Procedure
    Intervention Name(s)
    anti-VEGF
    Intervention Description
    vitreoretinal surgery combined with intraoperative anti-VEGF
    Intervention Type
    Procedure
    Intervention Name(s)
    fan-shaped photocoagulation
    Intervention Description
    vitreoretinal surgery combined with intraoperative fan-shaped photocoagulation
    Primary Outcome Measure Information:
    Title
    Mean change from baseline in best-corrected visual acuity (BCVA)
    Description
    Assessed using the ETDRS protocol
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Mean change from baseline in visual field
    Description
    Assessed on Humphery(30-2 and 60-4)
    Time Frame
    3 years
    Title
    chang from baseline in structure of retina
    Description
    Assessed on Optical Coherence Tomography(OCT)
    Time Frame
    3 years
    Title
    chang from baseline in retinal neovascularization
    Description
    Assessed on Fundus Fluorescein Angiography(FFA)
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years old; BRVO is diagnosed Vitreous hemorrhage Vitreous hemorrhage combined with mild retinal fibrovascular proliferation (early fibrous vascular membrane, thin fibrous vascular membrane, loose retinal adhesion and intact local retinal structure) Exclusion Criteria: BRVO combined with severe retinal fibrovascular proliferation (long-term fibrovascular membrane, thick fibrous vascular membrane and tightly attached to the retina, deformation of local retinal, retinal tear or suspension of retinal vein ) BRVO combined with retinal detachment Retinal veins are completely whitened iris neovascularization or neovascular glaucoma Combined glaucoma combined with other retinopathy Received anti-VEGF treatment within 3 months before surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yong Wei, M.D
    Phone
    +86 15057551266
    Email
    weiyongdoctor@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei Lin, M.D
    Phone
    +86 13587560390
    Email
    linweiysg@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yong Wei, M.D
    Organizational Affiliation
    The Eye Hospital of Wenzhou Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Anti-VEGF Instead of Intraoperative Fan-shaped Photocoagulation in BRVO Combined With Vitreous Hemorrhage

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