Expanded Access to Bimatoprost (Durysta)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05338606|
Expanded Access Status : Available
First Posted : April 21, 2022
Last Update Posted : April 21, 2022
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|Condition or disease||Intervention/treatment|
|Open-angle Glaucoma||Drug: Bimatoprost Sustained Release Implant|
|Study Type :||Expanded Access|
|Expanded Access Type :||Individual Patients|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||Expanded Access to Bimatoprost|
- Drug: Bimatoprost Sustained Release Implant
Intraocular ImplantOther Names:
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05338606
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|Study Director:||ABBVIE INC.||AbbVie|
|Other Study ID Numbers:||
|First Posted:||April 21, 2022 Key Record Dates|
|Last Update Posted:||April 21, 2022|
|Last Verified:||April 2022|
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