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Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy

Primary Purpose

Familial Exudative Vitreoretinopathies

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bromfenac Sodium
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Familial Exudative Vitreoretinopathies

Eligibility Criteria

1 Month - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed patients with familial exudative vitreoretinopathy
  • Needing diode laser photocoagulation
  • Consent to the study

Exclusion Criteria:

  • History of corneal diseases
  • History of hypersensitivity to bromfenac sodium
  • History of hypersensitivity to non-steroidal anti-inflammatory drugs
  • Progressive ocular infection
  • Liver diseases
  • Hypersensitivity to sulfur dioxide
  • Receiving anti-coagulation drugs
  • History of coagulopathies

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bromfenac sodium hydrate eye drops

    Arm Description

    The patients will receive bromfenac sodium hydrate eye drops twice daily for 14 days.

    Outcomes

    Primary Outcome Measures

    Macular edema response rate
    Presence of macular edema

    Secondary Outcome Measures

    Conjunctival injection response rate
    Presence of conjunctival injection

    Full Information

    First Posted
    October 23, 2021
    Last Updated
    October 23, 2021
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05107921
    Brief Title
    Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy
    Official Title
    Efficacy of Bromfenac Sodium Hydrate Eye Drops in Children With Familial Exudative Vitreoretinopathy After Diode Laser Photocoagulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University 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
    This study aims to investigate the efficacy and safety of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.
    Detailed Description
    This study aims to evaluate the presence of macular edema as the primary measure and the presence of conjunctival injection as the secondary measure for the investigation of the efficacy of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Familial Exudative Vitreoretinopathies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    39 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bromfenac sodium hydrate eye drops
    Arm Type
    Experimental
    Arm Description
    The patients will receive bromfenac sodium hydrate eye drops twice daily for 14 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Bromfenac Sodium
    Other Intervention Name(s)
    Bronuck
    Intervention Description
    The study participants will receive bromfenac sodium hydrate eyedrops twice daily for 14 days.
    Primary Outcome Measure Information:
    Title
    Macular edema response rate
    Description
    Presence of macular edema
    Time Frame
    4 weeks after the diode laser photocoagulation
    Secondary Outcome Measure Information:
    Title
    Conjunctival injection response rate
    Description
    Presence of conjunctival injection
    Time Frame
    4 weeks after the diode laser photocoagulation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Newly diagnosed patients with familial exudative vitreoretinopathy Needing diode laser photocoagulation Consent to the study Exclusion Criteria: History of corneal diseases History of hypersensitivity to bromfenac sodium History of hypersensitivity to non-steroidal anti-inflammatory drugs Progressive ocular infection Liver diseases Hypersensitivity to sulfur dioxide Receiving anti-coagulation drugs History of coagulopathies
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jeong Hun Kim, MD, PhD
    Phone
    82-2-2072-3446
    Email
    steph25@snu.ac.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeong Hun Kim, MD, PhD
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy

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