Clinical trial NCT04529512: INtravitreal and Aqueous Dexamethasone Levels After DEXtenza
Official title: INtravitreal and Aqueous Dexamethasone Levels After DEXtenza
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ocular Disease Requiring Surgery
Lead sponsor: California Retina Consultants
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2020-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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) 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.

Eligibility 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).

Primary outcomes:
measure: Intraocular dexamethasone levels
timeFrame: 8 months
Secondary outcomes:
measure: Post-operative pain levels
timeFrame: 8 months
Other outcomes:
Locations:
city: Paso Robles
country: United States
facility: California Retina Consultants
state: California
city: San Luis Obispo
country: United States
facility: California Retina Consultants
state: California
city: Santa Maria
country: United States
facility: California Retina Consultants
state: California
Study officials:
affiliation: Director of Research
name: Gabe Gordon, PhD
role: STUDY_DIRECTOR
affiliation: Physician
name: Nathan Steinle, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.