Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will
compare the relative efficacy and safety of intravitreal methotrexate, intravitreal
ranibizumab, and the intravitreal dexamethasone implant for the treatment of uveitic macular
edema persisting or reoccurring after an intravitreal corticosteroid injection. MERIT is a
parallel design (1:1:1), randomized comparative trial with an anniversary close-out at the 6
month clinic visit. The primary outcome is percent change in central subfield thickness from
the baseline OCT measurement to the 12 week visit.
Phase
Phase 3
Funding Agency/Sponsor
Other
Disease
Retina
Enrollment Eligibility
Inclusion criteria:
Patient level inclusion criterion
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);
7. Media clarity and pupillary dilation sufficient to allow OCT testing and assessment of
the fundus.
Exclusion criteria:
Patient level exclusion criteria
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;
Eye level exclusion criteria - at least one eye that meets all inclusion criteria
cannot have any of the following conditions
11. History of infectious endophthalmitis;
12. 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);
13. History of active noninfectious scleritis in past 12 months (Note: History of
noninfectious scleritis is acceptable if the last episode of active scleritis resolved
at least 12 months prior to enrollment);
14. 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);
15. Torn or ruptured posterior lens capsule
16. Presence of silicone oil;
17. Ozurdex administered in past 12 weeks;
18. Anti-VEGF agent, intravitreal methotrexate, or intravitreal/periocular corticosteroid
administered in past 4 weeks;
19. Fluocinolone acetonide implant (Retisert) placed in past 3 years.