Expanded Access to Bimatoprost (Durysta)
- Conditions
- Open-angle Glaucoma
- Registration Number
- NCT05338606
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
-
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
Not provided
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method