Non-infectious Anterior UveitisPhase 4DiverTNCT04426734
Evaluation of DEXTENZA in the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids
A Phase 4 study testing Dextenza Dexamethasone Implant and Topical Prednisolone Acetate 1% in people with Non-infectious Anterior Uveitis, run by New England Retina Associates.
Trial summary
This a prospective study review of the clinical efficacy of DEXTENZA for the treatment of anterior uveitis compared to the standard of care topical corticosteroid treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-infectious Anterior Uveitis
- What is being tested?
- Dextenza Dexamethasone Implant and Topical Prednisolone Acetate 1%
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 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
- > 18 years old
- Active non-infectious anterior uveitis
- Able to provide signed written consent prior to participation in any study-related procedures.
Who cannot join
- Have active intermediate, posterior uveitis, or panuveitis
- Have infectious anterior uveitis
- Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit
- Have used oral corticosteroid within the past 14 days prior to baseline visit (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study)
- Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit
- Are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no change in dosing is anticipated for the duration of the study
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- Have severe/serious ocular pathology or medical condition which may preclude study completion
- Dacriocystitis
- Are pregnant or lactating female, or female of childbearing age using inadequate birth control method
- Have participated in another investigational device or drug study within 30 days of the baseline visit
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of DEXTENZA on the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids
This a prospective study review of the clinical efficacy of DEXTENZA for the treatment of anterior uveitis compared to the standard of care topical corticosteroid treatment
Read the detailed description
Patients with anterior uveitis are typically treated aggressively with every 1-2 hour (while the patient is awake) potent topical steroid agents, during initial stage of inflammation, and evaluated at frequent intervals, with a schedule of steroid tapering dictated by clinical response. The most common topical corticosteroid prescribed for the treatment of anterior uveitis are prednisolone acetate 1%, dexamethasone 0.1%, prednisolone sodium phosphate 1% and Difluprednate 0.05%. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent or suspension of use nature of application. A corticosteroid insert placed in the inferior and superior canaliculi provides the advantages of reliable and continuous drug delivery for 24 hours a day for 30 days without the need for patients to adhere to a treatment regimen. Dextenza is a sustained-release dexamethasone intracanalicular insert recently approved by the FDA for pain and inflammation post ophthalmic surgery. Dextenza was shown to decrease inflammation and pain compared with placebo following cataract surgery in a multicenter randomized clinical trial.
- Conditions
- Non-infectious Anterior Uveitis
- Being tested
- Dextenza Dexamethasone Implant, Topical Prednisolone Acetate 1%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextenza Dexamethasone ImplantDevice
The area of the punctum is first anesthetized with eye drops. A localized injection of lidocaine in perform once the surface of the punctum is numbed with the eyedrop. After 5-10 minutes, the corner of the eyelid and the region of the punctum will be fully anesthetic. The upper and lower punctum are then dilated with a punctum dilator to facilitate the insertion of the DEXTENZA medication. The DEXTENZA medication is then inserted using smooth forceps into the dilated opening of the upper and lower punctum. Once the DEXTENZA is inserted into the both the upper and lower punctum, the procedure is down. No repeated insertion of the DEXTENZA is required for the study.
Topical Prednisolone Acetate 1%Drug
Also called Topical Pred Forte 1%
Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of
8x/day week 1 4x/day week 2 2x/day week 3
1x/day week 4
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30
| Study group | Role | What they receive |
|---|---|---|
| Dextenza | Experimental | Sustained Released 0.4 mg Dexamethasone intracanalicular insert in both upper and lower punctum.
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30 Receives: Device: Dextenza Dexamethasone Implant |
| Topical Pred Forte 1% | Active comparator | Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of
8x/day week 1 4x/day week 2 2x/day week 3
1x/day week 4
Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30 Receives: Drug: Topical Prednisolone Acetate 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response of Anterior Uveitis to Treatment
Proportion of Subjects with Anterior Chamber Cell Grade of 0 from baseline at days 3, 7, 14, and 30
Measured: 30 days
Secondary outcomes (12)
Improve 2 grade levels by SUN grading system
- Proportion of subjects with a reduction in anterior chamber cell count score of 2 or more SUN grading scale levels from baseline at Days 3, 7, 14, and 30
Measured: 30 days
Mean change in cells
Mean change from baseline in anterior chamber cell scores at days 3, 7, 14 and 30.
Measured: 30 days
Mean change in flare
Mean change from baseline in anterior chamber cell flare scores at days 3, 7, 14 and 30.
Measured: 30 days
Time to zero inflammation
Time to anterior cell count score of zero from baseline over time
Measured: 30 days
OCT
Mean change from baseline in retinal thickness as measured by Optical Coherence Tomography (OCT)
Measured: 30 days
CME
Proportion of patients who develop cystoid macular edema from baseline at days 3, 7, 14, and 30
Measured: 30 days
Proportion of resolution of CME
Proportion of patients with resolution of retinal thickness (normalized retinal thickness) from baseline through day 30 as measured by OCT
Measured: 30 days
Mean change in Visual Acuity
Mean change in BCVA from baseline at days 3, 7, 14 and 30.
Measured: 30 days
IOP
Mean change in IOP from baseline at days 3, 7, 14 and 30.
Measured: 30 days
NEI-VQ-25
Mean change in NEI-VFQ 25 from baseline to day 30
Measured: 30 days
Rescue therapy
Percentage of study eyes requiring rescue treatment from baseline through day 30
Measured: 30 days
Adverse events
Incidence and severity of adverse events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-infectious Anterior UveitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Sustained Release Dexamethasone, 0.4 mg, intracanalicular insert Thirty patients with anterior uveitis will be randomized to receive either: Sustained Released 0.4 mg Dexamethasone intracanalicular insert in both upper and lower punctum. OR Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of 8x/day week 1 4x/day week 2 2x/day week 3 1x/day week 4 Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New England Retina Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix
- Responsible party
- Principal investigator, John Huang, MD, New England Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426734
- Sponsor's protocol ID
- OT V1
- Acronym
- DiverT
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: This data will be analyzed and published by the principle investigator.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of DEXTENZA on the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids
- ClinicalTrials.gov ID
- NCT04426734
- Acronym / sponsor ID
- DiverT / OT V1
- Conditions
- Non-infectious Anterior Uveitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New England Retina AssociatesUniversity, hospital or other
- Collaborators
- Ocular Therapeutix
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 11 Jun 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.
This a prospective study review of the clinical efficacy of DEXTENZA for the treatment of anterior uveitis compared to the standard of care topical corticosteroid treatment
Detailed description
Patients with anterior uveitis are typically treated aggressively with every 1-2 hour (while the patient is awake) potent topical steroid agents, during initial stage of inflammation, and evaluated at frequent intervals, with a schedule of steroid tapering dictated by clinical response. The most common topical corticosteroid prescribed for the treatment of anterior uveitis are prednisolone acetate 1%, dexamethasone 0.1%, prednisolone sodium phosphate 1% and Difluprednate 0.05%. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent or suspension of use nature of application. A corticosteroid insert placed in the inferior and superior canaliculi provides the advantages of reliable and continuous drug delivery for 24 hours a day for 30 days without the need for patients to adhere to a treatment regimen. Dextenza is a sustained-release dexamethasone intracanalicular insert recently approved by the FDA for pain and inflammation post ophthalmic surgery. Dextenza was shown to decrease inflammation and pain compared with placebo following cataract surgery in a multicenter randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sustained Release Dexamethasone, 0.4 mg, intracanalicular insert Thirty patients with anterior uveitis will be randomized to receive either: Sustained Released 0.4 mg Dexamethasone intracanalicular insert in both upper and lower punctum. OR Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of 8x/day week 1 4x/day week 2 2x/day week 3 1x/day week 4 Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30
| Arm | Type | Receives |
|---|---|---|
| Dextenza | Experimental | Device: Dextenza Dexamethasone ImplantSustained Released 0.4 mg Dexamethasone intracanalicular insert in both upper and lower punctum. Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30 |
| Topical Pred Forte 1% | Active comparator | Drug: Topical Prednisolone Acetate 1%Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of 8x/day week 1 4x/day week 2 2x/day week 3 1x/day week 4 Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years old
- Active non-infectious anterior uveitis
- Able to provide signed written consent prior to participation in any study-related procedures.
Key exclusion criteria (10 listed)
- Have active intermediate, posterior uveitis, or panuveitis
- Have infectious anterior uveitis
- Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit
- Have used oral corticosteroid within the past 14 days prior to baseline visit (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study)
- Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit
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 Dexamethasone ImplantThe area of the punctum is first anesthetized with eye drops. A localized injection of lidocaine in perform once the surface of the punctum is numbed with the eyedrop. After 5-10 minutes, the corner of the eyelid and the region of the punctum will be fully anesthetic. The upper and lower punctum are then dilated with a punctum dilator to facilitate the insertion of the DEXTENZA medication. The DEXTENZA medication is then inserted using smooth forceps into the dilated opening of the upper and lower punctum. Once the DEXTENZA is inserted into the both the upper and lower punctum, the procedure is down. No repeated insertion of the DEXTENZA is required for the study. | Device | Dextenza |
| Topical Prednisolone Acetate 1%Also: Topical Pred Forte 1%Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of 8x/day week 1 4x/day week 2 2x/day week 3 1x/day week 4 Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30 | Drug | Topical Pred Forte 1% |
Primary outcome
Response of Anterior Uveitis to Treatment
Time frame: 30 days
Proportion of Subjects with Anterior Chamber Cell Grade of 0 from baseline at days 3, 7, 14, and 30
12 secondary outcomes
Improve 2 grade levels by SUN grading system
Time frame: 30 days
Mean change in cells
Time frame: 30 days
Mean change in flare
Time frame: 30 days
Time to zero inflammation
Time frame: 30 days
OCT
Time frame: 30 days
CME
Time frame: 30 days
Proportion of resolution of CME
Time frame: 30 days
Mean change in Visual Acuity
Time frame: 30 days
IOP
Time frame: 30 days
NEI-VQ-25
Time frame: 30 days
Rescue therapy
Time frame: 30 days
Adverse events
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No. This data will be analyzed and published by the principle investigator.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextenza Dexamethasone Implant and Topical Prednisolone Acetate 1% in people with Non-infectious Anterior Uveitis, run by New England Retina Associates.
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 10 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 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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 John Huang (2032882020, jjqhuang@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of Anterior Uveitis to Treatment (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2020.