INtravitreal and Aqueous Dexamethasone Levels After DEXtenza

• Status: Not yet recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

A prospective, open-label, interventional study to determine intraocular concentration levels of dexamethasone following use of the DEXTENZA® implant.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nathan Steinle
• Collaborator: Ocular Therapeutix, Inc.
• Treatments: Dexamethasone

Criteria

Inclusion Criteria:

1. Patients of California Retina Consultants undergoing vitrectomy surgery

2. Must be 18 years old or older

3. Must be able to provide consent

Exclusion Criteria:

1. Must not have been treated with DEXTENZA® prior to joining the study.

2. May not have more than one DEXTENZA® implant.

3. May not be currently using an dexamethasone product during the course of the study or within 4 weeks prior to enrolling in the study.

4. 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

5. Any abnormal lid or punctum anatomy that would preclude or make inappropriate the placement of the insert (e.g., severe ectropion or punctal stenosis).