POINT

Principal Investigator: Albert Vitale
Keywords: Uveitis , Macular edema , corticosteroid treatments , comparative effectiveness Department: Ophthalmology-Services
IRB Number: 00080936 Co Investigator:  
Specialty: Ophthalmology, Ophthalmology
Sub Specialties: Uveitis, Retinal Diseases
Recruitment Status: Active, not recruiting

Contact Information

Kimberley Wegner
kimberley.wegner@hsc.utah.edu
801-581-6265

Brief Summary

To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema:  periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant.

The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks.

Inclusion Criteria

Patient level inclusion criterion:

  1. 18 years of age or older;

Eye level inclusion criteria - at least one eye must meet all of the following conditions

  1. Non-infectious anterior, intermediate, posterior or panuveitis; either active or inactive uveitis is acceptable;
  2. Macular edema (ME) defined as the presence of central subfield macular thickness greater than the normal range for the OCT machine being used (>300µm for Zeiss Cirrus/Topcon 3DOCT or >320 µm for Heidelberg Spectralis), regardless of the presence of cysts, as assessed by study ophthalmologist;
  3. Best corrected visual acuity (BCVA) 5/200 or better;
  4. Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of 3 or fewer intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable - note that combination medications, i.e., Cosopt, count as 2 IOP lowering medications);
  5. Baseline fluorescein angiogram that is gradeable for degree of leakage in the central subfield
  6. Pupillary dilation sufficient to allow OCT testing.

Exclusion Criteria

Patient level exclusion criteria:

  1. History of infectious endophthalmitis or invections uveitis in either eye;
  2. History of infectious scleritis of any type in either eye.  (Note: History of noninfectious scleritis that has been active in past 12 months is an eye level exclusion - see # 11 below.)
  3. History of keratitis (with the exception of keratitis due to dry eye) in either eye.
  4. History of central serous retinopathy in either eye.
  5. For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial;
  6. Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
  7. Oral prednisone  dose > 10 mg per day (or of an alternative corticosteroid at a dose higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose ≤ 10 mg per day at baseline that has not been stable for at least  4 weeks (note that if patient is off oral prednisone at baseline (P01 visit), dose stability requirement for past 4 weeks does not apply); 
  8. Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks;
  9. Known allergy or hypersensitivity to any component of the study drugs;

Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions:

10. 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);

11.  History of active noninfectious scleritis in past 12 months (Note: history of noninfectious scleritis is acceptable if the last episode of active scleritis resolved at least 12 months prior to enrollment.); 

12  Media opacity causing inability to assess fundus or perform OCT;

13.  Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of study ophthalmologist may be significant enough to limit improvement of ME (i.e., causing substantial wrinkling of the retinal surface)81;

14.  Torn or ruptured posterior lens capsule

15.  Presence of silicone oil;

16.  Periocular or intravitreal corticosteroid injection in past 8 weeks;

17.  Injection of dexamethasone intravitreal implant in past 12 weeks;

18.  Placement of  fluocinolone acetonide implant (Retisert) in past 3 years.