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Expanded Access to Bimatoprost (Durysta)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05338606
Expanded Access Status : Available
First Posted : April 21, 2022
Last Update Posted : April 21, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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.

Condition or disease Intervention/treatment
Open-angle Glaucoma Drug: Bimatoprost Sustained Release Implant

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Expanded Access to Bimatoprost

Resource links provided by the National Library of Medicine

Drug Information available for: Bimatoprost

Interventions
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Intervention Details:
  • Drug: Bimatoprost Sustained Release Implant
    Intraocular Implant
    Other Names:
    • AGN-192024
    • Durysta
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT05338606


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05338606    
Other Study ID Numbers: C21-630
First Posted: April 21, 2022    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: April 2022
Keywords provided by AbbVie:
Expanded Access
Pre-approval Access
Compassionate Use
 Special Access Program
Named Patient Basis
Special Access Scheme
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Glaucoma
Ocular Hypertension
 Eye Diseases
Bimatoprost
Antihypertensive Agents