Intravitreal Therapy for Uveitic Macular Edema-Ranibizumab versus Methotrexate versus the Dexamethasone Implant: The MERIT Trial Results

Abstract

Purpose: To evaluate the effectiveness of 3 different intravitreal treatments for persistent or recurrent uveitic macular edema (ME): dexamethasone implant, methotrexate, and ranibizumab.

Design: Single-masked, randomized controlled clinical trial.

Participants: Patients with minimally active or inactive uveitis and persistent or recurrent uveitic ME in one or both eyes.

Methods: Patients at 33 centers were randomized 1:1:1 to receive 1 of the 3 therapies. Patients with bilateral ME received the same treatment in both eyes.

Main outcome measures: The primary outcome, measured at 12 weeks, was reduction in central subfield thickness (CST) expressed as a proportion of baseline (CST per CST at baseline) assessed with spectral-domain OCT by readers masked to treatment assignment. Secondary outcomes included improvement and resolution of ME, change in best-corrected visual acuity (BCVA), and elevations in intraocular pressure (IOP).

Results: One hundred ninety-four participants (225 eligible eyes) were randomized to dexamethasone (n = 65 participants and 77 eyes), methotrexate (n = 65 participants and 79 eyes), or ranibizumab (n = 64 participants and 69 eyes). All received at least 1 injection of the assigned treatment. At the 12-week primary outcome point, each group showed significant reductions in CST relative to baseline: 35%, 11%, and 22% for dexamethasone, methotrexate, and ranibizumab, respectively. Reduction of ME was significantly greater in the dexamethasone group than for either methotrexate (P < 0.01) or ranibizumab (P = 0.018). Only the dexamethasone group showed a statistically significant improvement in BCVA during follow-up (4.86 letters; P < 0.001). Elevations of IOP by 10 mmHg, to 24 mmHg or more, or both were more common in the dexamethasone group; IOP spikes to 30 mmHg or more were uncommon overall and were not significantly different among groups. Reductions in BCVA of 15 letters or more were more common in the methotrexate group and typically were attributable to persistent ME.

Conclusions: At 12 weeks, in eyes with minimally active or inactive uveitis, dexamethasone was significantly better at treating persistent or recurrent ME than methotrexate or ranibizumab. Risk of IOP elevation was greater with dexamethasone, but elevations to levels of 30 mmHg or more were infrequent.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Trial registration: ClinicalTrials.gov NCT02623426.

Keywords: Uveitic macular edema.

Figure 1.

Consort diagram of the MERIT Trial. N represents the number of individuals with the number of eyes with uveitis in parentheses. N = number (eligible eyes); IOP = intraocular pressure; FU =follow-up

Figure 4.

Proportion of eyes with a 20% or greater decrease in OCT central subfield thickness, (a) and normalization of OCT central subfield thickness, (b) in macular edema at each visit for intravitreal dexamethasone implant (solid line, triangle), methotrexate (dashed line, circle), and ranibizumab (staggered line, square). *Calculated from the subset of eligible eyes with uveitic macular edema at enrollment.

Figure 4.

Proportion of eyes with a 20% or greater decrease in OCT central subfield thickness, (a) and normalization of OCT central subfield thickness, (b) in macular edema at each visit for intravitreal dexamethasone implant (solid line, triangle), methotrexate (dashed line, circle), and ranibizumab (staggered line, square). *Calculated from the subset of eligible eyes with uveitic macular edema at enrollment.