Macular Edema Ranibizumab versus Intravitreal Anti-inflammatory Therapy Trial: 24-Week Outcomes of Uveitic Macular Edema Re-treatment.

PURPOSE: Evaluation of longer-term effectiveness of 3 intravitreal therapies (methotrexate, ranibizumab, or dexamethasone implant) for participants enrolled in the randomized comparative effectiveness trial the Macular Edema Ranibizumab versus Intravitreal Anti-inflammatory Therapy (MERIT) Trial followed up for 24 weeks.

DESIGN

Multicenter randomized controlled clinical trial with masked evaluation of retinal thickness and visual acuity.

PARTICIPANTS

Patients with persistent or recurrent uveitic macular edema.

METHODS

Participants from 33 centers were randomized 1:1:1 (stratified by presence or absence of concomitant systemic immunosuppression for uveitis) to receive a sequence of intravitreal treatments with dexamethasone implant, methotrexate, or ranibizumab. Participants with bilateral macular edema received the same treatment bilaterally. During 24 weeks of follow-up, nonassigned treatments were permitted beginning from 12 weeks for those meeting re-treatment criteria.

MAIN OUTCOME MEASURES: Central subfield thickness (CST) change from baseline OCT measurement was the main outcome. Secondary outcomes included change in mean standard letters of baseline best-corrected visual acuity (BCVA). Analyses were conducted according to 2 principles: (1) as assigned, in which outcomes were analyzed according to their original randomized treatment, and (2) a supplementary censored analysis, in which data were excluded after an eye received a nonassigned treatment.

RESULTS

Among 194 enrolled participants (225 eligible eyes), 177 participants (207 eyes) completed 24 weeks of follow-up. Eyes assigned to methotrexate (55%) and ranibizumab (37%) more frequently received nonassigned treatments (88% dexamethasone implant or intravitreal corticosteroid injection) compared with eyes assigned to dexamethasone (7%). In the as-assigned analysis, dexamethasone showed superior improvement in macular edema compared with ranibizumab (CST, 34% vs. 19%; P = 0.01), but not compared with methotrexate (CST, 31%; P = 0.59) after being superior to both other regimens at 12 weeks. However, in the censored analysis, only dexamethasone was associated with improvements in macular edema (CST, 34% vs 8% [P < 0.001] and 5% [P < 0.001]) and BCVA improvement of > 5 letters compared with methotrexate and ranibizumab, respectively. Dexamethasone more often was associated with intraocular pressure elevations of ≥ 24 mmHg (32%) and of ≥ 30 mmHg (10%).

CONCLUSIONS

Dexamethasone was more effective than methotrexate and ranibizumab for the treatment of persistent or recurrent uveitic macular edema through 24 weeks, with manageable side effects.

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