MERIT

Principal Investigator: Albert Vitale
Keywords: uveitis , macular edema , anti-inflammatory treatment Department: Ophthalmology-Services
IRB Number: 00092362 Co Investigator:  
Specialty: Ophthalmology, Ophthalmology
Sub Specialties: Uveitis, Retinal Diseases
Recruitment Status: Recruiting

Contact Information

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

Brief Summary

The MERIT Trial was designed to find out which intravitreal therapy offers the best balance of effectiveness and tolerability in treating persistent or recurrent uveitic macular edema in eyes with controlled uveitis, specifically by comparing the relative efficacy and safety of intravitreal ranibizumab (Lucentis®) and intravitreal methotrexate to intravitreal dexamethasone implant (Ozurdex®) for the treatment of persistent/recurrent uveitic macular edema.

Genentech will provide Lucentis (Ranibizumab 0.5 mg per 0.05 mL) and support its distribution to clinical centers.

 

 

Inclusion Criteria

  1. 18 years of age or older;
  2. Inactive or minimally active non-infectious anterior, intermediate, posterior or panuveitis, as defined by standard uveitis nomenclature (SUN) criteria as ≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze grade and no active retinal/choroidal lesions for a minimum of 4 weeks; 
  3. Macular edema (ME) defined as the presence of macular thickness greater than the normal range for the OCT machine being used (see cut points below), regardless of the presence of cysts, following most recent intravitreal corticosteroid injection (≥ 4 weeks following intravitreal triamcinolone injection or ≥ 12 weeks following intravitreal dexamethasone implant injection);
    • Greater than 300 μm for Zeiss Cirrus
    • Greater than 320 μm for Heidelberg Spectralis
    • Greater than 300 μm for Topcon 3DOCT
  4. Baseline fluorescein angiogram that, as assessed by the study ophthalmologist, is gradable for degree of leakage in the central subfield;

  5. Best corrected visual acuity (BCVA) 5/200 or better;

  6. Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of ≤3 intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable (Note combination medications, e.g.,  Combigan,  are counted as two IOP-lowering medications)

  7. Media clarity and pupillary dilation sufficient to allow OCT testing and assessment of the fundus.

Exclusion Criteria

  1. History of infectious uveitis in either eye
  1. History of infectious scleritis of any type in either eye (Note: History of non-infectious scleritis that has been active in past 12 months is an eye-level exclusion - see # 13 below);
  2. History of keratitis (with the exception of keratitis due to dry eye) in either eye:
  3. History of central serous retinopathy in either eye;
  4. Active infectious conjunctivitis in either eye
  5. 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: if patient is off of oral prednisone at baseline (M01 study visit) dose stability requirement for past 4 weeks does not apply);
  6. Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks (note use of systemic methotrexate is acceptable as long as regimen has been stable for at least 4 weeks);
  7. Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
  8. Known allergy or hypersensitivity to any component of the study drugs;
  9. 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;
  10. History of infectious endophthalmitis;
  11. 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);
  12. 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);
  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);
  14. Torn or ruptured posterior lens capsule
  15. Presence of silicone oil;
  16. Ozurdex administered in past 12 weeks;
  17. Anti-VEGF agent, intravitreal methotrexate, or intravitreal/periocular corticosteroid administered in past 4 weeks;
  18. Fluocinolone acetonide implant (Retisert) placed in past 3 years.