Status:
NO_LONGER_AVAILABLE
Expanded Access to Bimatoprost (Durysta)
Lead Sponsor:
AbbVie
Conditions:
Open-angle Glaucoma
Eligibility:
All Genders
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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05338606
Last Update
February 10 2025
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