INtravitreal and Aqueous Dexamethasone Levels After DEXtenza

Status unconfirmed · Phase 4

Conditions studied: Ocular Disease Requiring Surgery

In brief

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

Key facts

Study ID

NCT04529512

Run by

Nathan Steinle

People needed

40

Starts

2021-03-01

Expected to finish

2021-03-01

Last updated by the study team

2021-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients of California Retina Consultants undergoing vitrectomy surgery
• Must be 18 years old or older
• Must be able to provide consent

You may not qualify if…

• 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).

Where it is running

• California Retina Consultants — Paso Robles, California, United States
• California Retina Consultants — San Luis Obispo, California, United States
• California Retina Consultants — Santa Maria, California, United States

Full record on ClinicalTrials.gov

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