INtravitreal and Aqueous Dexamethasone Levels After DEXtenza

Ocular Disease Requiring Surgery Clinical Trial

— INDEX  

Official title:

INtravitreal and Aqueous Dexamethasone Levels After DEXtenza

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04529512
• Other study ID #: INDEX
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 2021
• Est. completion date: March 2021

Study information

• Verified date: January 2021
• Source: California Retina Consultants
• Contact: Gabriel Gordon, PhD
• Phone: (805) 963-1648
• Email: gabe[@]californiaretina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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) for DEXTENZA® to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication.

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.

In the two phase III trials, patients were given DEXTENZA® or its vehicle immediately after cataract surgery. In the first study, 80 percent of DEXTENZA®-treated patients (n=164) were pain-free at the eighth day compared to 43 percent of vehicle-treated patients (n=83) (p<0.0001). In the second trial, 77 percent of patients on active drug (n=161) were pain-free at the eighth day vs. 59 percent of those on the vehicle.1

Safety was assessed from the three Phase 3 clinical trials and a Phase 2 clinical trial.1,2 Overall, 567 subjects were exposed to DEXTENZA®. The most common ocular adverse reactions in subjects treated with DEXTENZA® were: anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse event was headache (1%).

Though DEXTENZA has been found to be safe and effective, it is a relatively new therapy and a randomized prospective study looking at dexamethasone and pain levels following retinal surgery has not yet been done. The purpose of this study is to provide real-world intraocular dexamethasone concentration levels in subjects implanted with DEXTENZA as well as to confirm the reduction of pain in patients undergoing retinal surgery is the same as subjects who underwent cataract surgery in the phase III studies.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Ocular Disease Requiring Surgery

Intervention

Drug:
• DEXTENZA®
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.

Locations

Country	Name	City	State
United States	California Retina Consultants	Paso Robles	California
United States	California Retina Consultants	San Luis Obispo	California
United States	California Retina Consultants	Santa Maria	California

Sponsors (2)

Lead Sponsor	Collaborator
Nathan Steinle	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Erratum in: J Cataract Refract Surg. 2019 Jun;45(6):895. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative pain levels	The secondary objective of this study is to assess post-operative pain levels in subjects with or without the DEXTENZA® implant following retinal surgery. This will be assessed using a pain post-surgery questionnaire.This will be assessed using a pain post-surgery questionnaire consisting of an an 11-point likert scale (0-10), with 0 being no pain and 10 being excruciating pain	8 months