Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial

Part of paid clinical trials in Los Angeles, California.

Sponsor
JHSPH Center for Clinical Trials
Study ID
NCT02623426
Phase
PHASE3
Status
Completed

Conditions

  • Macular Edema
  • Uveitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone intravitreal implant 0.7 mg — DRUG
    Standard preparation as described for intravitreal injections.
  • Intravitreal Methotrexate 400 µg — DRUG
    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.
  • Intravitreal Ranibizumab 0.5 mg — DRUG
    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.

Study Details

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.

Key Dates

First listed
Dec 7, 2015
Start date
Mar 9, 2017
Status verified
Jun 2023
Primary completion
Oct 27, 2021
Completion
Feb 2, 2022

Study Design

Enrollment
194 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dexamethasone intravitreal implant 0.7mg
    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: 1. 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. 2. 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;
  • Active Comparator: Intravitreal methotrexate 400µg in 0.1mL
    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.
  • Active Comparator: Intravitreal ranibizumab 0.5mg in 0.05mL
    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.

Primary Outcome Measure

Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks [ Time Frame: At 12-week visit ]

Locations (19)

FacilityCityStateZIPSite coordinators
Jules Stein Eye Institute, UCLALos AngelesCalifornia90095-
University of California, San FranciscoSan FranciscoCalifornia94143-
Anne Bates Leach Eye Hospital, University of Miami Miller School of MedicineMiamiFlorida33136-
Emory UniversityAtlantaGeorgia30322-
Northwestern UniversityChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
University of IowaIowa CityIowa52242-
University of LouisvilleLouisvilleKentucky40202-
Johns Hopkins UniversityBaltimoreMaryland21287-
Massachusetts Eye and Ear InfirmaryBostonMassachusetts02114-
Ophthalmic Consultants of BostonBostonMassachusetts02114-
Kellogg Eye Center, University of MichiganAnn ArborMichigan48105-
Duke Eye Center, Duke UniversityDurhamNorth Carolina27710-
MidAtlanitc Retina, Wills Eye HospitalPhiladelphiaPennsylvania19107-
Scheie Eye Institute, University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
VanderbiltNashvilleTennessee37232-
Retinal Consultants of HoustonHoustonTexas77030-
John A. Moran Eye Center, University of UtahSalt Lake CityUtah84132-

Find similar trials in Los Angeles, CA

By research site
Jules Stein Eye Institute, UCLA· Los Angeles, CAUniversity of California, San Francisco· San Francisco, CAAnne Bates Leach Eye Hospital, University of Miami Miller School of Medicine· Miami, FLEmory University· Atlanta, GANorthwestern University· Chicago, ILRush University Medical Center· Chicago, IL

Related Studies