MedTrace Logo

Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial

NCT02623426 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2023-07-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Uveitis
  • Macular Edema

Interventions

DRUG

Dexamethasone intravitreal implant 0.7 mg

Standard preparation as described for intravitreal injections.

DRUG

Intravitreal Methotrexate 400 µg

Intravitreal Methotrexate 400 µg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to the injection.

DRUG

Intravitreal Ranibizumab 0.5 mg

Intravitreal Ranibizumab 0.5 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to the injection.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • JHSPH Center for Clinical Trials

    lead OTHER

Principal Investigators

  • Douglas A Jabs, MD, MBA · Center for Clinical Trials and Evidence Synthesis, JHU, Baltimore, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2021-10-27
Completion
2022-02-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • India
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02623426 on ClinicalTrials.gov