INtravitreal and Aqueous Dexamethasone Levels After DEXtenza

NCT04529512 | Unknown Phase 4 FDA Drug

• 1 other identifier: INDEX
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Ocular Disease Requiring Surgery

Outcome Measures

Primary Outcomes (1)

• Intraocular dexamethasone levels

  The primary objective is to determine intraocular dexamethasone levels by obtaining aqueous and intravitreal samples at the time of routine retina surgery after placement of DEXTENZA® prior to surgery; tear films will also be analyzed for osmolarity and dexamethasone levels.prior to starting the vitrectomy procedure (including eye prep), the physician will collect the subject's tear film for assessment of osmolarity and dexamethasone levels using a Schirmer test strip which will be stored in an Eppendorf tube on ice until it can be frozen and shipped to a lab for analysis.

  8 months

Secondary Outcomes (1)

• Post-operative pain levels

  8 months

Study Arms (4)

Receiving DEXTENZA® 1-3 days prior to surgery

EXPERIMENTAL

Participants to receive DEXTENZA® 1-3 days prior to surgery

Drug: DEXTENZA®

Receiving DEXTENZA® 1-2 weeks prior to surgery

EXPERIMENTAL

Participants to receive DEXTENZA® 1-2 weeks prior to surgery

Drug: DEXTENZA®

Receiving DEXTENZA® 1 month prior to surgery

EXPERIMENTAL

Participants to receive DEXTENZA® 1 month prior to surgery

Drug: DEXTENZA®

Not receiving the DEXTENZA® implant

NO INTERVENTION

Participants will not receive the DEXTENZA® implant

Interventions

DEXTENZA® DRUG

DEXTENZA® is a corticosteroid implant indicated for the treatment of ocular pain following ophthalmic surgery. DEXTENZA® is inserted into the lower lacrimal punctum into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA® releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA® is preservative free, resorbable and does not require removal. Saline irrigation or manual expression can be performed to remove the insert, if necessary.

Also known as: dexamethasone ophthalmic insert 0.4mg

Receiving DEXTENZA® 1 month prior to surgery; Receiving DEXTENZA® 1-2 weeks prior to surgery; Receiving DEXTENZA® 1-3 days prior to surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Nathan Steinle: lead
• Ocular Therapeutix, Inc.: collaborator

Study Sites (3)

California Retina Consultants

Paso Robles, California, 93446, United States

Location

California Retina Consultants

San Luis Obispo, California, 93401, United States

Location

California Retina Consultants

Santa Maria, California, 93454, United States

Location

Related Publications (2)

• Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019 Feb;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023. Epub 2018 Oct 24.

  PMID: 30367938 BACKGROUND

• Torkildsen G, Abelson MB, Gomes PJ, McLaurin E, Potts SL, Mah FS. Vehicle-Controlled, Phase 2 Clinical Trial of a Sustained-Release Dexamethasone Intracanalicular Insert in a Chronic Allergen Challenge Model. J Ocul Pharmacol Ther. 2017 Mar;33(2):79-90. doi: 10.1089/jop.2016.0154. Epub 2017 Jan 10.

  PMID: 28072552 BACKGROUND

MeSH Terms

Interventions

Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Gabe Gordon, PhD

  Director of Research

  STUDY DIRECTOR

• Nathan Steinle, MD

  Physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Gordon, PhD

CONTACT

(805) 963-1648; gabe@californiaretina.com

Mary Lopez-Isidro, B.S

CONTACT

805-266-7123; mary.lopez-isidro@californiaretina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 27, 2020
• Study Start: March 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Don't know yet
• Access Criteria: Don't know yet

Locations

US (3)