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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Wendy Smith, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available
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CLS-20258280

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