PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
Condition: Macular Edema; Uveitis
MeSH terms: Macular Edema; Uveitis; Edema
Intervention: Periocular triamcinolone 40 mg; Intravitreal triamcinolone 4 mg; Dexamethasone intravitreal implant
Intervention description: Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.; Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.; • Standard preparation as described for intravitreal injections.
Intervention MeSH terms: Dexamethasone; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
      Participants will continue in the study for 24 weeks in order to evaluate relative effects of
      the 3 treatment strategies on the duration of treatment effects, requirement for additional
      injections, and adverse effects.

      Note: The planned sample size for the POINT Trial was 267 subjects. On 17 July 2017, with 192
      subjects enrolled, the Data and Safety Monitoring Committee (DSMC) reviewed the planned
      interim analysis and recommended that the goals of the trial could be accomplished by
      completing follow-up of enrolled subjects without the recruitment of additional subjects. Per
      the DSMC recommendations, recruitment was suspended and follow-up of enrolled subjects was
      completed according to the protocol.
    

Eligibility criteria:

        Inclusion Criteria:

        Eye level 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 (ME) 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 (BCVA) 5/200 or better;

          -  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);

          -  Baseline fluorescein angiogram that is gradable for leakage in the central subfield

          -  Pupillary dilation sufficient to allow OCT testing.

        Exclusion Criteria:

        Patient level exclusion criteria:

        -History of infectious uveitis, or of scleritis, keratitis, or infectious endophthalmitis
        in either eye;

        History of central serous retinopathy in either eye;

          -  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;

          -  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) OR oral prednisone dose ≤ 10
             mg per day that has not been stable for at least 4 weeks(note that if patient is off
             of oral prednisone at baseline (P01 visit), dose stability requirement for past 4
             weeks does not apply);

          -  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;

        Eye level exclusion criteria - at least one 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)81;

          -  Torn or ruptured posterior lens capsule;

          -  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;