Overview

Evaluation of DEXTENZA in the Management of Pain and Inflammation in Patients With Anterior Uveitis Compared to Standard of Care Topical Corticosteroids

Status:
Not yet recruiting
Trial end date:
2021-03-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New England Retina Associates
Collaborator:
Ocular Therapeutix
Treatments:
Dexamethasone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Criteria
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