INtravitreal and Aqueous Dexamethasone Levels After DEXtenza
NCT ID: NCT04529512
Last Updated: 2021-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2021-03-31
2021-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Receiving DEXTENZA® 1-3 days prior to surgery
Participants to receive DEXTENZA® 1-3 days prior to surgery
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.
Receiving DEXTENZA® 1-2 weeks prior to surgery
Participants to receive DEXTENZA® 1-2 weeks prior to surgery
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.
Receiving DEXTENZA® 1 month prior to surgery
Participants to receive DEXTENZA® 1 month prior to surgery
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.
Not receiving the DEXTENZA® implant
Participants will not receive the DEXTENZA® implant
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must be 18 years old or older
3. Must be able to provide consent
Exclusion Criteria
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).
18 Years
ALL
No
Sponsors
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Ocular Therapeutix, Inc.
INDUSTRY
Nathan Steinle
OTHER
Responsible Party
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Nathan Steinle
Principal Investigator
Principal Investigators
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Gabe Gordon, PhD
Role: STUDY_DIRECTOR
Director of Research
Nathan Steinle, MD
Role: PRINCIPAL_INVESTIGATOR
Physician
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Gabe Gordon, PhD
Role: primary
Mary Lopez-Isidro
Role: backup
References
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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.
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.
Other Identifiers
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INDEX
Identifier Type: -
Identifier Source: org_study_id