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Expanded Access to Bimatoprost (Durysta)

Primary Purpose

Open-angle Glaucoma

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Bimatoprost Sustained Release Implant
Sponsored by
AbbVie
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Open-angle Glaucoma focused on measuring Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participant must not be eligible for bimatoprost implant (Durysta) clinical trial.
  • Eligibility for this program is limited to patients with moderate or worse glaucoma who are at risk of severe visual impairment based on physician assessment of risk factors associated with visual field progression as defined by the respective country/regional glaucoma clinical practice guidelines (eg, Canadian Ophthalmological Society guidelines, European Glaucoma Society guidelines, etc.), and who have exhausted all the appropriate pharmaceutical treatment options and are contraindicated for surgery, which may include:

    • Patients with ocular comorbidities such as severely scarred conjunctiva (eg, chemical burns, Stevens-Johnson Syndrome), scleral thinning.
    • Patients who are intolerant to any pre- , intra-, or post-op treatments (e.g allergy/intolerance to medical treatments or to anesthesia).
    • Patients with systemic comorbidities (e.g cardiovascular conditions) in which any surgery is not recommended

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    April 13, 2022
    Last Updated
    April 10, 2023
    Sponsor
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05338606
    Brief Title
    Expanded Access to Bimatoprost (Durysta)
    Official Title
    Expanded Access to Bimatoprost
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie

    4. Oversight

    5. Study Description

    Brief Summary
    This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Durysta (Bimatoprost) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open-angle Glaucoma
    Keywords
    Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Bimatoprost Sustained Release Implant
    Other Intervention Name(s)
    AGN-192024, Durysta
    Intervention Description
    Intraocular Implant

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The participant must not be eligible for bimatoprost implant (Durysta) clinical trial. Eligibility for this program is limited to patients with moderate or worse glaucoma who are at risk of severe visual impairment based on physician assessment of risk factors associated with visual field progression as defined by the respective country/regional glaucoma clinical practice guidelines (eg, Canadian Ophthalmological Society guidelines, European Glaucoma Society guidelines, etc.), and who have exhausted all the appropriate pharmaceutical treatment options and are contraindicated for surgery, which may include: Patients with ocular comorbidities such as severely scarred conjunctiva (eg, chemical burns, Stevens-Johnson Syndrome), scleral thinning. Patients who are intolerant to any pre- , intra-, or post-op treatments (e.g allergy/intolerance to medical treatments or to anesthesia). Patients with systemic comorbidities (e.g cardiovascular conditions) in which any surgery is not recommended
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ABBVIE CALL CENTER
    Phone
    844-663-3742
    Email
    abbvieclinicaltrials@abbvie.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ABBVIE INC.
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Access to Bimatoprost (Durysta)

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