Non-infectious Anterior Uveitis Clinical Trial
— DiverTOfficial 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
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | March 31, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - > 18 years old - Active non-infectious anterior uveitis - Able to provide signed written consent prior to participation in any study-related procedures. Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
New England Retina Associates | Ocular Therapeutix |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 30 days | |
Secondary | 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 | 30 days | |
Secondary | Mean change in cells | Mean change from baseline in anterior chamber cell scores at days 3, 7, 14 and 30. | 30 days | |
Secondary | Mean change in flare | Mean change from baseline in anterior chamber cell flare scores at days 3, 7, 14 and 30. | 30 days | |
Secondary | Time to zero inflammation | Time to anterior cell count score of zero from baseline over time | 30 days | |
Secondary | OCT | Mean change from baseline in retinal thickness as measured by Optical Coherence Tomography (OCT) | 30 days | |
Secondary | CME | Proportion of patients who develop cystoid macular edema from baseline at days 3, 7, 14, and 30 | 30 days | |
Secondary | 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 | 30 days | |
Secondary | Mean change in Visual Acuity | Mean change in BCVA from baseline at days 3, 7, 14 and 30. | 30 days | |
Secondary | IOP | Mean change in IOP from baseline at days 3, 7, 14 and 30. | 30 days | |
Secondary | NEI-VQ-25 | Mean change in NEI-VFQ 25 from baseline to day 30 | 30 days | |
Secondary | Rescue therapy | Percentage of study eyes requiring rescue treatment from baseline through day 30 | 30 days | |
Secondary | Adverse events | Incidence and severity of adverse events | 30 days |
Status | Clinical Trial | Phase | |
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