Ocular Disease Requiring SurgeryPhase 4INDEXNCT04529512
INtravitreal and Aqueous Dexamethasone Levels After DEXtenza
A Phase 4 study testing DEXTENZA® in people with Ocular Disease Requiring Surgery, run by Nathan Steinle at 3 sites in United States.
Trial summary
A prospective, open-label, interventional study to determine intraocular concentration levels of dexamethasone following use of the DEXTENZA® implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Disease Requiring Surgery
- What is being tested?
- DEXTENZA®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2021to Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of California Retina Consultants undergoing vitrectomy surgery
- Must be 18 years old or older
- Must be able to provide consent
Who cannot join
- 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:
- Epithelial herpes simplex keratitis (dendritic keratitis)
- Vaccini
Show all 11Show fewer
- Varicella
- Mycobacterial infections
- Fungal diseases of the eye
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
California Retina Consultants
Paso Robles, California, 93446
California Retina Consultants
San Luis Obispo, California, 93401
California Retina Consultants
Santa Maria, California, 93454
Gabe Gordon, PhD, 805-963-1648, gabe@californiaretina.com
Mary Lopez-Isidro, 805-266-7123, mary.lopez-isidro@californiaretina.com
About this study
A prospective, open-label, interventional study to determine intraocular concentration levels of dexamethasone following use of the DEXTENZA® implant.
Read the 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.
- Conditions
- Ocular Disease Requiring Surgery
- Being tested
- DEXTENZA®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXTENZA®Drug
Also called dexamethasone ophthalmic insert 0.4mg
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.
| Study group | Role | What they receive |
|---|---|---|
| Receiving DEXTENZA® 1-3 days prior to surgery | Experimental | Participants to receive DEXTENZA® 1-3 days prior to surgery Receives: Drug: DEXTENZA® |
| Receiving DEXTENZA® 1-2 weeks prior to surgery | Experimental | Participants to receive DEXTENZA® 1-2 weeks prior to surgery Receives: Drug: DEXTENZA® |
| Receiving DEXTENZA® 1 month prior to surgery | Experimental | Participants to receive DEXTENZA® 1 month prior to surgery Receives: Drug: DEXTENZA® |
| Not receiving the DEXTENZA® implant | No intervention | Participants will not receive the DEXTENZA® implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 months
Secondary outcomes (1)
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
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study startMar 2021 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ocular Disease Requiring SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nathan Steinle
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor-investigator, Nathan Steinle, California Retina Consultants
- Investigators
- Gabe Gordon, PhD, Study director, Director of ResearchNathan Steinle, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529512
- Sponsor's protocol ID
- INDEX
- Acronym
- INDEX
- Status last verified
- Jan 2021
- First submitted
- 11 Aug 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified study data will be published in a peer-review journal once the study is completed.
Publications
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.
PubMed 30367938Torkildsen 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.
PubMed 28072552
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtravitreal and Aqueous Dexamethasone Levels After DEXtenza
- ClinicalTrials.gov ID
- NCT04529512
- Acronym / sponsor ID
- INDEX / INDEX
- Conditions
- Ocular Disease Requiring Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nathan SteinleUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Receiving DEXTENZA® 1-3 days prior to surgery | Experimental | Drug: DEXTENZA®Participants to receive DEXTENZA® 1-3 days prior to surgery |
| Receiving DEXTENZA® 1-2 weeks prior to surgery | Experimental | Drug: DEXTENZA®Participants to receive DEXTENZA® 1-2 weeks prior to surgery |
| Receiving DEXTENZA® 1 month prior to surgery | Experimental | Drug: DEXTENZA®Participants to receive DEXTENZA® 1 month prior to surgery |
| Not receiving the DEXTENZA® implant | No intervention | –Participants will not receive the DEXTENZA® implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of California Retina Consultants undergoing vitrectomy surgery
- Must be 18 years old or older
- Must be able to provide consent
Key exclusion criteria (11 listed)
- 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:
- Any abnormal lid or punctum anatomy that would preclude or make inappropriate the placement of the insert (e.g., severe ectropion or punctal stenosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEXTENZA®Also: dexamethasone ophthalmic insert 0.4mgDEXTENZA® 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. | Drug | Receiving DEXTENZA® 1 month prior to surgery, Receiving DEXTENZA® 1-2 weeks prior to surgery, Receiving DEXTENZA® 1-3 days prior to surgery |
Primary outcome
Intraocular dexamethasone levels
Time frame: 8 months
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.
1 secondary outcome
Post-operative pain levels
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Background: PubMed 30367938Tyson 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.
- Background: PubMed 28072552Torkildsen 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.
- Individual participant dataSharing planned: Yes. De-identified study data will be published in a peer-review journal once the study is completed.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabe Gordon, PhD study director
Director of Research
Nathan Steinle, MD principal investigator
Physician
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DEXTENZA® in people with Ocular Disease Requiring Surgery, run by Nathan Steinle at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Gordon, PhD ((805) 963-1648 ext. 2400, gabe@californiaretina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular dexamethasone levels (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04529512, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.