A Study to Compare the Effectiveness of Three Eye Corticosteroids for Treating Uveitic Macular Edema

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-001744
    NCT ID: NCT02374060
    Sponsor Protocol Number: IRB00006139

About this study

The purpose of this study is to evaluate the relative effects of three commonly used corticosteroids for the treatment of uveitic macular edema (swelling of the middle tissue layer of the eye)  measured by the duration of treatment effects, requirements for additional injections, and any adverse effects.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • At least one eye must meet all of the following conditions
    • Non-infectious anterior, intermediate, posterior or panuveitis
      • Either active or inactive uveitis is acceptable
    • Macular edema defined as the presence of central subfield macular thickness greater than the normal range for the OCT machine being used, regardless of the presence of cysts, as assessed by study ophthalmologist
    • Best corrected visual acuity of 20/40 to 5/200
    • Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg
      • Current use of 2 or fewer intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable
    • Baseline fluorescein angiogram that is gradable for leakage in the central subfield
    • Pupillary dilation sufficient to allow OCT testing

Exclusion Criteria

  • Patient must not have any of these
    • History of infectious uveitis, or of scleritis, keratitis, or endophthalmitis in either eye
    • 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
    • Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline
    • 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) 
    • Oral prednisone dose ≤ 10 mg per day that has not been stable for at least 4 weeks
    • Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks
    • Known allergy or hypersensitivity to any component of the study drugs
  • The eye that meets all inclusion criteria cannot have any of the following conditions
    • 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)
    • Media opacity causing inability to assess fundus or perform OCT
    • 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)
    • Presence of silicone oil
    • Periocular or intravitreal corticosteroid injection in past 8 weeks
    • Injection of dexamethasone intravitreal implant in past 12 weeks
    • Placement of fluocinolone acetonide implant (Retisert) in past 3 years
    • Topical NSAID use if dose has not been stable for at least 4 weeks

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wendy Smith, M.D.

Closed for enrollment

Contact information:

JaMario Ayers

(507)538-4122

Ayers.Mario@mayo.edu

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CLS-20258280

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