PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
Description
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.
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.
Detailed Description
Macular edema is the most common structural complication and leading cause of visual loss in
patients with uveitis. Regional injections of corticosteroids are the most frequently used
treatments specifically for uveitic macular edema but there is a lack of high quality
evidence to guide choice of drug (e.g., triamcinolone acetonide, dexamethasone) and route of
administration (e.g. periocular, intravitreal). The question of how to approach regional
treatment of uveitic macular edema is a key question for ophthalmologists treating these
patients. The Periocular and Intravitreal Corticosteroids for Uveitic Macular Edema (POINT)
Trial is a randomized trial designed to compare the relative efficacy of three regional
corticosteroids commonly utilized for the initial regional treatment of uveitic macular
edema, periocular triamcinolone (Kenalog® , Bristol-Myers Squibb Company, Princeton, NJ),
intravitreal triamcinolone (Triesence™, Alcon Pharmaceuticals, Fort Worth, TX), and the
intravitreal dexamethasone implant (Ozurdex®, Allergan, Irvine CA) will be conducted by the
MUST Research Group clinical centers throughout the U.S. and one each in Australia and the
UK. After signing informed consent and undergoing eligibility evaluation, eligible patients
will be randomized to one of the three study treatments to be administered at the first study
visit. Randomization is by participant, if both eyes meet eligibility requirements then both
eyes receive assigned treatment. The design outcome is the percent change in central subfield
macular thickness on OCT from baseline to the 8 week visit. After assessment of the primary
outcome at 8 weeks, second injections and best medical judgment will be used if macular edema
has not improved as follows:
Eye(s) meeting trial eligibility criteria receive initial injection of assigned treatment at
P01 visit.
Second injection of assigned treatment permitted at 8 week visit for periocular triamcinolone
and intravitreal triamcinolone and at 12 week visit for intravitreal dexamethasone if
- Eye does not meet the improvement definition (a 20% decrease in central subfield
thickness of the macula) or
- Eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central
subfield or
- ME is worse after initial improvement
And the following repeat injection criterion are met:
• IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Eyes demonstrating no improvement or worsening of ME as measured by the central submacular
thickness on OCT (at week 12 for periocular and intravitreal triamcinolone arms and at week
20 for intravitreal dexamethasone arm) are considered primary treatment non-responders.
Phase
Phase 4 - refines the treatment to become part of standard care.Inclusion and Exclusion 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
- -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;
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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