Expanded Access to Bimatoprost (Durysta)

Sponsor

AbbVie (Industry)

Overall Status

Available

CT.gov ID

NCT05338606

Collaborator

(none)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma	Drug: Bimatoprost Sustained Release Implant

Study Design

Study Type:

Expanded Access

Official Title:

Expanded Access to Bimatoprost

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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