Status:
UNKNOWN
INtravitreal and Aqueous Dexamethasone Levels After DEXtenza
Lead Sponsor:
Nathan Steinle
Collaborating Sponsors:
Ocular Therapeutix, Inc.
Conditions:
Ocular Disease Requiring Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A prospective, open-label, interventional study to determine intraocular concentration levels of dexamethasone following use of the DEXTENZA® implant.
Detailed Description
On December 3rd, 2018, DEXTENZA® was approved by the FDA for the treatment of ocular pain following ophthalmic surgery. On June 21st, 2019, the FDA approved a Supplemental New Drug Application (sNDA) ...
Eligibility Criteria
Inclusion
- Patients of California Retina Consultants undergoing vitrectomy surgery
- Must be 18 years old or older
- Must be able to provide consent
Exclusion
- Must not have been treated with DEXTENZA® prior to joining the study.
- May not have more than one DEXTENZA® implant.
- May not be currently using an dexamethasone product during the course of the study or within 4 weeks prior to enrolling in the study.
- Subject has active corneal, conjunctival or canalicular infections, including:
- i. Epithelial herpes simplex keratitis (dendritic keratitis)
- ii. Vaccini
- iii. Varicella
- iv. Mycobacterial infections
- v. Fungal diseases of the eye
- vi. Dacryocystitis
- Any abnormal lid or punctum anatomy that would preclude or make inappropriate the placement of the insert (e.g., severe ectropion or punctal stenosis).
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04529512
Start Date
March 1 2021
End Date
March 1 2021
Last Update
January 29 2021
Active Locations (3)
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1
California Retina Consultants
Paso Robles, California, United States, 93446
2
California Retina Consultants
San Luis Obispo, California, United States, 93401
3
California Retina Consultants
Santa Maria, California, United States, 93454