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NCT05338606 Clinical Trial

Expanded Access to Bimatoprost (Durysta)

Open-angle Glaucoma Clinical Trial

Official title:
Expanded Access to Bimatoprost

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05338606
Other study ID # C21-630
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date April 2024
Source AbbVie
Contact ABBVIE CALL CENTER
Phone 844-663-3742
Email abbvieclinicaltrials@abbvie.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bimatoprost Sustained Release Implant
Intraocular Implant

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AbbVie
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