Expanded Access to Bimatoprost (Durysta)

NCT05338606 | Unknown

• 1 other identifier: C21-630
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Open-angle Glaucoma

Keywords

Expanded Access; Pre-approval Access; Compassionate Use; Special Access Program; Named Patient Basis; Special Access Scheme

Interventions

Bimatoprost Sustained Release Implant DRUG

Intraocular Implant

Also known as: AGN-192024, Durysta

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 21, 2022
• Last Updated: February 10, 2025

Record last verified: 2025-02