Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT02374060
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;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02374060
Study Brief:
Protocol Section:
NCT02374060