Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial - MERIT Trial

MUST Coordinating Centre, John Hopkins Bloomberg School of Public Health0 sites240 target enrollmentSeptember 12, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: MUST Coordinating Centre, John Hopkins Bloomberg School of Public Health
Enrollment: 240
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

September 12, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

MUST Coordinating Centre, John Hopkins Bloomberg School of Public Health

•1\.18 years of age or older;
•Eye level inclusion criteria \- at least one eye must meet all of the following conditions
•2\.Inactive or minimally active non\-infectious anterior, intermediate, posterior or panuveitis, as defined by SUN132 criteria as \= 0\.5\+ anterior chamber cells, \= 0\.5\+ vitreous haze grade and no active retinal/choroidal lesions for a minimum of 4 weeks;
•3\.Macular edema (ME) defined as the presence of macular thickness greater than the normal range for the OCT machine being used (see cut points below), regardless of the presence of cysts, following an intravitreal corticosteroid injection (\= 4 weeks following intravitreal triamcinolone injection or \= 12 weeks following intravitreal dexamethasone implant injection);
•Greater than 300 µm for Zeiss Cirrus
•Greater than 320 µm for Heidelberg Spectralis
•Greater than 300 µm for Topcon 3DOCT
•4\.Baseline fluorescein angiogram that, as assessed by the study ophthalmologist, is gradable for degree of leakage in the central subfield;
•5\.Best corrected visual acuity (BCVA) 5/200 or better;
•6\.Baseline intraocular pressure \> 5 mm Hg and \= 21 mm Hg (current use of \=3 intraocular pressure\-lowering medications and/or prior glaucoma surgery are acceptable (Note: combination medications, e.g., Combigan, are counted as two IOP\-lowering medications);

•1\.History of infectious uveitis in either eye;
•2\.History of infectious scleritis of any type in either eye (Note: History of noninfectious scleritis that has been active in past 12 months is an eye\-level exclusion –see \#13 below);
•3\.History of keratitis (with the exception of keratitis due to dry eye) in either eye;
•4\.History of central serous retinopathy in either eye;
•5\.Active infectious conjunctivitis in either eye;
•6\.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 at baseline that has not been stable for at least 4 weeks (note: if patient is off of oral prednisone at baseline (M01 study visit) dose stability requirement for past 4 weeks does not apply);
•7\.Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks (note: use of systemic methotrexate is acceptable as long as regimen has been stable for at least 4 weeks);
•8\.Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
•9\.Known allergy or hypersensitivity to any component of the study drugs;
•10\.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;