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Corticosteroid

Intravitreal methotrexate 400µg in 0.1mL for Uveitis (MERIT Trial)

Phase 3
Waitlist Available
Research Sponsored by JHSPH Center for Clinical Trials
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 24 weeks of follow-up
Awards & highlights

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 after 6 months of follow-up. The primary outcome is percent change in central subfield thickness from the baseline OCT measurement to the 12 week visit.

Eligible Conditions
  • Uveitis
  • Macular Edema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 24 weeks of follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 24 weeks of follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks
Secondary outcome measures
>= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction
Change in Best-corrected Visual Acuity
Change in Macular Thickness as Measured by OCT
+8 more

Trial Design

3Treatment groups
Active Control
Group I: Intravitreal methotrexate 400µg in 0.1mLActive Control1 Intervention
Participants were randomized to a treatment group. A participant may have 1 or 2 eyes with macular edema (eligible eyes) receiving the same treatment. Eligible eye(s) treated at study visit M01 (week 0). Retreatment required at M02 (4 weeks) and M03 (8 weeks) if retreatment criteria met. Retreatment permitted at later time points if retreatment criteria met. Minimum time between treatments: minimum target is 4 weeks after last injection but re-injection permitted as early as 23 days after last injection.
Group II: Intravitreal ranibizumab 0.5mg in 0.05mLActive Control1 Intervention
Participants were randomized to a treatment group. A participant may have 1 or 2 eyes with macular edema (eligible eyes) receiving the same treatment. Eligible eye(s) treated at study visits M01 (week 0), M02 (4 weeks), and M03 (8 weeks). Retreatment permitted at M04 (12 weeks) and at later time points if retreatment criteria met. Minimum time between treatments: minimum target is 4 weeks after last injection but re-injection permitted as early as 23 days after last injection. Re-treatment permitted at later time points if re-treatment criteria met.
Group III: Dexamethasone intravitreal implant 0.7mgActive Control1 Intervention
Participants were randomized to a treatment group. A participant may have 1 or 2 eyes with macular edema (eligible eyes) receiving the same treatment. Eligible eye(s) treated at study visit M01 (week 0). Retreatment required at study visit M03 (8 weeks) if re-treatment criteria met. Retreatment permitted at later time points if retreatment criteria met. Re-treatment criteria: Central subfield thickness greater than 1.1X upper limit of normal (330 μm for Zeiss and Topcon Spectral Domain (SD) Optical Coherence Tomography (OCT) and 352 μm for Heidelberg OCT) and/or cystoid space(s) within 1 mm central subfield. IOP of <25 mm Hg (treatment with ≤3 IOP-lowering agents permitted) Minimum time between treatments: minimum target is 8 weeks after last injection but re-injection permitted as early as 51 days after last injection;

Find a Location

Who is running the clinical trial?

National Eye Institute (NEI)NIH
548 Previous Clinical Trials
1,401,681 Total Patients Enrolled
47 Trials studying Uveitis
17,980 Patients Enrolled for Uveitis
JHSPH Center for Clinical TrialsLead Sponsor
12 Previous Clinical Trials
10,158 Total Patients Enrolled
3 Trials studying Uveitis
669 Patients Enrolled for Uveitis
Douglas A Jabs, MD, MBAStudy ChairCenter for Clinical Trials and Evidence Synthesis, JHU, Baltimore, MD
2 Previous Clinical Trials
292 Total Patients Enrolled
1 Trials studying Uveitis
192 Patients Enrolled for Uveitis
~23 spots leftby Sep 2025
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