AZALEA

Principal Investigator: Albert Vitale
Keywords: Inflammatory eye Disease , Intraocular injection Department: Ophthalmology-Services
IRB Number: 00101204 Co Investigator:  
Specialty: Ophthalmology, Ophthalmology
Sub Specialties: Uveitis, Retinal Diseases
Recruitment Status: Active, not recruiting

Contact Information

Susan Allman
susan.allman@hsc.utah.edu
801-581-5142

Brief Summary

Primary:

To evaluate the safety of suprachoroidally administered CLS-TA in subjects with non- infectious uveitis.


Secondary:
• To assess changes to signs and complications of uveitis
• To collect use information on the suprachoroidal injection procedure

Inclusion Criteria

Individuals are eligible for participation in this study ifs/he meets all of the following criteria:

  1. A diagnosis of non-infectious uveitis of any etiology for which the administration of local corticosteroid therapy would be a viable treatment option; either anterior-, intermediate-, posterior- or pan-uveitis are acceptable; both active and inactive uveitis are acceptable
  2. ETDRS BCVA score of > 5 letters read in the study eye
  3. Understands the language of the informed consent; willing and able to provide written informed consent prior to any study procedures; willing to comply with the instructions and attend all scheduled study visits
  4. At least 18 years of age

Exclusion Criteria

An individual is ineligible for participation in this study ifs/he meets any of the following

criteria:

1. Has significant media opacity in the study eye precluding evaluation of the retina and vitreous

2. Any active ocular disease or infection in the study eye other than uveitis

3. Intraocular pressure > 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye at Visit 1; subjects are not excluded if IOP is < 22 mmHg in the study eye with no more than 2 IOP lowering medications

4. Has a history of severe glaucoma as defined by optic nerve damage (cup/disc ratio of > 0.9 or any notching of optic nerve to the rim)

5. Has had cyclodestructive procedures or filtration surgeries in the study eye in the 3 months prior to Visit 2

6. Has high myopia in the study eye defined as a spherical equivalent > -6 diopters or an axial length > 26 mm

7. Has had photocoagulation or cryotherapy in the study eye within the 6 months prior to Visit 2

8. Has had any IVT injection of anti-vascular endothelial growth factor treatment (bevacizumab, aflibercept, pegaptanib or ranibizumab) in the study eye in the 30 days prior to Visit 2

9. In the study eye, any topical ocular corticosteroid in the 10 days prior to Visit 2; intraocular and periocular corticosteroid injection in the 2 months prior to Visit 2; an Ozurdex® implant in the 6 months prior to Visit 2; Retisert™, or Iluvien® implant in the 3 years prior to Visit 2