Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial

  • STATUS
    Recruiting
  • days left to enroll
    76
  • participants needed
    240
  • sponsor
    JHSPH Center for Clinical Trials
Updated on 25 January 2021
angiography
edema
corticosteroids
methotrexate
triamcinolone
dexamethasone
cysts
ranibizumab
corrected visual acuity
macular edema
fluorescein angiography
glaucoma
panuveitis
dexamethasone intravitreal implant
pupil dilation
triamcinolone injection

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.

Description

Macular edema (ME) is the most common structural complication and cause of visual impairment and legal blindness in uveitis patients. Traditional approaches to the treatment of uveitic ME have included the use of regional corticosteroid therapy, delivered periocularly, including posterior sub-Tenon's and orbital floor injections, or via the intravitreal route. While corticosteroid injections may reduce ME and improve vision, the effect is often variable with a limited duration. Persistent macular edema is a common occurrence and often requires repeated intravitreal injections of corticosteroids, which expose eyes to a significant risk of increased intraocular pressure ocular and cataract development. The often refractory nature of uveitic ME and its impact on visual function underscores the need to identify effective alternative medical therapeutic options. Recent pilot studies have shown intravitreal methotrexate (MTX) and intravitreal ranibizumab (Lucentis, Genentech Inc., San Francisco, CA) to be promising treatments for uveitic ME, and intravitreal dexamethasone implant (Ozurdex, Allergan, Irvine, CA) has recently been approved by the U.S. FDA for uveitic ME in patients with non-infectious uveitis. In addition to being effective, intravitreal MTX and ranibizumab potentially may have less ocular side effects than corticosteroids, particularly less IOP elevation. However, the relative efficacy of these treatments is unknown. The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, ranibizumab, and dexamethasone implant. MERIT is a parallel design (1:1:1), randomized comparative effectiveness 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.

Details
Condition Macular Edema, age-related macular degeneration, Uveitis, Cystoid Macular Edema, Macular Degeneration
Treatment Dexamethasone intravitreal implant 0.7 mg, Intravitreal Methotrexate 400 µg, Intravitreal Ranibizumab 0.5 mg
Clinical Study IdentifierNCT02623426
SponsorJHSPH Center for Clinical Trials
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Macular Degeneration or Uveitis or age-related macular degeneration or Macular Edema or Cystoid Macular Edema?
Do you have any of these conditions: age-related macular degeneration or Cystoid Macular Edema or Uveitis or Macular Edema or Macular Degeneration?
Patient level inclusion criterion
18 years of age or older
Eye level inclusion criteria - at least one eye must meet all of the following
conditions
\. 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
\. 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 m for Zeiss Cirrus Greater than 320 m for Heidelberg
Spectralis Greater than 300 m for Topcon 3DOCT
\. Baseline fluorescein angiogram that, as assessed by the study
ophthalmologist, is gradable for degree of leakage in the central subfield
\. Best corrected visual acuity (BCVA) 5/200 or better
\. 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)
\. Media clarity and pupillary dilation sufficient to allow OCT testing and
assessment of the fundus

Exclusion Criteria

Patient level exclusion criteria
History of infectious uveitis in either eye
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)
History of keratitis (with the exception of keratitis due to dry eye) in either eye
History of central serous retinopathy in either eye
Active infectious conjunctivitis in either eye
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)
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)
Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline
Known allergy or hypersensitivity to any component of the study drugs
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
\. History of infectious endophthalmitis
\. 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)
\. 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)
\. 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)
\. Torn or ruptured posterior lens capsule
\. Presence of silicone oil
\. Ozurdex administered in past 12 weeks
\. Anti-VEGF agent, intravitreal methotrexate, or intravitreal/periocular
corticosteroid administered in past 4 weeks
\. Fluocinolone acetonide implant (Retisert) placed in past 3 years
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