Status:
UNKNOWN
Evaluation of DEXTENZA in the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids
Lead Sponsor:
New England Retina Associates
Collaborating Sponsors:
Ocular Therapeutix
Conditions:
Non-infectious Anterior Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
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...
Eligibility Criteria
Inclusion
- \> 18 years old
- Active non-infectious anterior uveitis
- Able to provide signed written consent prior to participation in any study-related procedures.
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04426734
Start Date
July 1 2020
End Date
March 31 2021
Last Update
June 11 2020
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