UveitisPhase 3MERITNCT02623426
Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial
A Phase 3 study testing Dexamethasone intravitreal implant 0.7 mg, Intravitreal Methotrexate 400 µg and Intravitreal Ranibizumab 0.5 mg in people with Uveitis and Macular Edema, run by JHSPH Center for Clinical Trials at 33 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Macular Edema
- What is being tested?
- Dexamethasone intravitreal implant 0.7 mg, Intravitreal Methotrexate 400 µg and Intravitreal Ranibizumab 0.5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 33 sitesin 5 countries
- Study dates
- 9 Mar 2017to 2 Feb 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient level inclusion criterion
- 18 years of age or older;
- Eye level inclusion criteria - at least one eye must meet all of the following conditions
- Inactive or minimally active non-infectious anterior, intermediate, posterior or panuveitis, as defined by the Standardization of Uveitis Nomenclature (SUN) Working Group criteria as ≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze grade and no active retinal/choroidal lesions for a minimum of 4 weeks;
- Macular edema (ME) defined as the presence of macular thickness greater than the normal range for the OCT machine being used (see cut points below), regardless of the presence of cysts, following an intravitreal corticosteroid injection (≥ 4 weeks following intravitreal triamcinolone injection or ≥ 12 weeks following intravitreal dexamethasone implant injection);
- Greater than 300 μm for Zeiss Cirrus Greater than 320 μm for Heidelberg Spectralis Greater than 300 μm for Topcon SD OCT
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- Baseline fluorescein angiogram that, as assessed by the study ophthalmologist, is gradable for degree of leakage in the central subfield;
- Best corrected visual acuity (BCVA) 5/200 or better;
- Baseline intraocular pressure > 5 mm Hg and ≤ 21 mm Hg (current use of ≤3 intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable (Note: combination medications, e.g., Combigan, are counted as two IOP-lowering medications);
- Media clarity and pupillary dilation sufficient to allow OCT testing and assessment of the fundus.
Who cannot join
- Patient level exclusion criteria
- History of infectious uveitis in either eye;
- History of infectious scleritis of any type in either eye (Note: History of noninfectious scleritis that has been active in past 12 months is an eye-level exclusion -see #13 below);
- History of keratitis (with the exception of keratitis due to dry eye) in either eye;
- History of central serous retinopathy in either eye;
- Active infectious conjunctivitis in either eye;
Show all 21Show fewer
- Oral prednisone dose > 10 mg per day (or of an alternative corticosteroid at a dose higher than that equipotent to prednisone 10 mg per day) OR oral prednisone dose ≤ 10 mg per day at baseline that has not been stable for at least 4 weeks (note: if patient is off of oral prednisone at baseline (M01 study visit) dose stability requirement for past 4 weeks does not apply);
- Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks (note: use of systemic methotrexate is acceptable as long as regimen has been stable for at least 4 weeks);
- Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
- Known allergy or hypersensitivity to any component of the study drugs;
- For women of childbearing potential: pregnancy, breastfeeding, or a positive pregnancy test; unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for duration of trial;
- Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions
- History of infectious endophthalmitis;
- History of severe glaucoma as defined by optic nerve damage (cup/disc ratio of ≥ 0.9 or any notching of optic nerve to the rim);
- History of active noninfectious scleritis in past 12 months (Note: History of noninfectious scleritis is acceptable if the last episode of active scleritis resolved at least 12 months prior to enrollment);
- Presence of an epiretinal membrane noted clinically or by OCT that per the judgment of study ophthalmologist may be significant enough to limit improvement of ME (i.e., causing substantial wrinkling of the retinal surface);
- Torn or ruptured posterior lens capsule
- Presence of silicone oil;
- Ozurdex administered in past 12 weeks;
- Anti-vascular endothelial growth factor (VEGF) agent, intravitreal methotrexate, or intravitreal/periocular corticosteroid administered in past 4 weeks;
- Fluocinolone acetonide implant (Retisert) placed in past 3 years.
Trial locations and contacts
33 sites in 5 countries.
33 sites in 5 countries
United States19 sites
Kellogg Eye Center, University of Michigan
Ann Arbor, Michigan, 48105
Emory University
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21287
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Duke Eye Center, Duke University
Durham, North Carolina, 27710
Retinal Consultants of Houston
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Jules Stein Eye Institute, UCLA
Los Angeles, California, 90095
University of Louisville
Louisville, Kentucky, 40202
Anne Bates Leach Eye Hospital, University of Miami Miller School of Medicine
Miami, Florida, 33136
Vanderbilt
Nashville, Tennessee, 37232
Scheie Eye Institute, University of Pennsylvania
Philadelphia, Pennsylvania, 19104
MidAtlanitc Retina, Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
John A. Moran Eye Center, University of Utah
Salt Lake City, Utah, 84132
University of California, San Francisco
San Francisco, California, 94143
United Kingdom8 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B152WB
University Hospitals Bristol NHS Foundation Trust
Bristol, England, BS1 2LX
Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, CB2 0QQ
University Hospitals of Leicester NHS Trust
Leicester, England, LE1 5WW
Liverpool University Hospitals NHS Foundation Trust
Liverpool, England, L7 8XP
Moorfields Eye Hospital NHS Foundation Trust
London, England, EC1V 2PD
Moorfields Eye Hospital
London, EC1V 9EL
Manchester University NHS Foundation Trust
Manchester, England, M13 (WL
India4 sites
LV Prasad Eye Institute - Bhubaneswar
Bhubaneswar, Odisha
Advanced Eye Center, Post Graduate Institute of Medical Education and Research
Chandigarh
Medical and Vision Research Foundation
Chennai, Tamil Nadu
LV Prasad Eye Institute - Hyderabad
Hyderabad, Telangana, 500034
Australia1 site
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria
About this study
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.
Read the detailed description
Macular edema (ME) is the most common structural complication and cause of visual impairment and legal blindness in uveitis patients. Traditional approaches to the treatment of uveitic ME have included the use of regional corticosteroid therapy, delivered periocularly, including posterior sub-Tenon's and orbital floor injections, or via the intravitreal route. While corticosteroid injections may reduce ME and improve vision, the effect is often variable with a limited duration. Persistent macular edema is a common occurrence and often requires repeated intravitreal injections of corticosteroids, which expose eyes to a significant risk of increased intraocular pressure ocular and cataract development. The often refractory nature of uveitic ME and its impact on visual function underscores the need to identify effective alternative medical therapeutic options. Recent pilot studies have shown intravitreal methotrexate (MTX) and intravitreal ranibizumab (Lucentis®, Genentech Inc., San Francisco, CA) to be promising treatments for uveitic ME, and intravitreal dexamethasone implant (Ozurdex®, Allergan, Irvine, CA) has recently been approved by the U.S. FDA for uveitic ME in patients with non-infectious uveitis. In addition to being effective, intravitreal MTX and ranibizumab potentially may have less ocular side effects than corticosteroids, particularly less IOP elevation. However, the relative efficacy of these treatments is unknown. The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, ranibizumab, and dexamethasone implant. MERIT is a parallel design (1:1:1), randomized comparative effectiveness 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
- Being tested
- Dexamethasone intravitreal implant 0.7 mg, Intravitreal Methotrexate 400 µg, Intravitreal Ranibizumab 0.5 mg
- Keywords
- uveitic macular edema, uveitis
- Medical subject headings
- Uveitis, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone intravitreal implant 0.7 mgDrug
Also called Ozurdex
Standard preparation as described for intravitreal injections.
Intravitreal Methotrexate 400 µgDrug
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 mgDrug
Also called Lucentis
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 group | Role | What they receive |
|---|---|---|
| Dexamethasone intravitreal implant 0.7mg | Active comparator | 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; Receives: Drug: Dexamethasone intravitreal implant 0.7 mg |
| Intravitreal methotrexate 400µg in 0.1mL | Active comparator | 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. Receives: Drug: Intravitreal Methotrexate 400 µg |
| Intravitreal ranibizumab 0.5mg in 0.05mL | Active comparator | 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. Receives: Drug: Intravitreal Ranibizumab 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks
The primary outcome is the change in central subfield thickness from baseline to 12 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. The proportion of baseline subfield thickness is estimated by a mixed effect model that includes time points for baseline, week 4, week 8, and week 12 and the treatment group. The treatment effect is the interaction (product) of time point and treatment. Contrasts of the model parameter estimates were used to calculate the change from baseline to week 12 and the comparison between treatment groups.
Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases (improvement).The OCT outcomes were measured by masked readers. The 12-week visit was chosen as the time to assess the primary outcome because of the ranibizumab treatment schedule and the peak effect time for dexamethasone
Measured: At 12-week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study start9 Mar 2017
- Primary completion27 Oct 2021
- Study completion2 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- JHSPH Center for Clinical Trials
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Douglas A Jabs, MD, MBA, Study chair, Center for Clinical Trials and Evidence Synthesis, JHU, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623426
- Sponsor's protocol ID
- 119247
- Other IDs
- U10EY024527, ML29257
- Acronym
- MERIT
- Status last verified
- Jun 2023
- First submitted
- 3 Dec 2015
- Last updated
- 10 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Multicenter Uveitis Steroid Treatment Trial (MUST) Research Group, Writing Committee:; Acharya NR, Vitale AT, Sugar EA, Holbrook JT, Burke AE, Thorne JE, Altaweel MM, Kempen JH, Jabs DA. Intravitreal Therapy for Uveitic Macular Edema-Ranibizumab versus Methotrexate versus the Dexamethasone Implant: The MERIT Trial Results. Ophthalmology. 2023 Sep;130(9):914-923. doi: 10.1016/j.ophtha.2023.04.011. Epub 2023 Jun 13.
PubMed 37318415
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial
- ClinicalTrials.gov ID
- NCT02623426
- Acronym / sponsor ID
- MERIT / 119247
- Conditions
- Uveitis, Macular Edema
- Keywords
- uveitic macular edema, uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- JHSPH Center for Clinical TrialsUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 2 Feb 2022 (actual)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Posted 10 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Macular edema (ME) is the most common structural complication and cause of visual impairment and legal blindness in uveitis patients. Traditional approaches to the treatment of uveitic ME have included the use of regional corticosteroid therapy, delivered periocularly, including posterior sub-Tenon's and orbital floor injections, or via the intravitreal route. While corticosteroid injections may reduce ME and improve vision, the effect is often variable with a limited duration. Persistent macular edema is a common occurrence and often requires repeated intravitreal injections of corticosteroids, which expose eyes to a significant risk of increased intraocular pressure ocular and cataract development. The often refractory nature of uveitic ME and its impact on visual function underscores the need to identify effective alternative medical therapeutic options. Recent pilot studies have shown intravitreal methotrexate (MTX) and intravitreal ranibizumab (Lucentis®, Genentech Inc., San Francisco, CA) to be promising treatments for uveitic ME, and intravitreal dexamethasone implant (Ozurdex®, Allergan, Irvine, CA) has recently been approved by the U.S. FDA for uveitic ME in patients with non-infectious uveitis. In addition to being effective, intravitreal MTX and ranibizumab potentially may have less ocular side effects than corticosteroids, particularly less IOP elevation. However, the relative efficacy of these treatments is unknown. The Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial will compare the relative efficacy and safety of intravitreal methotrexate, ranibizumab, and dexamethasone implant. MERIT is a parallel design (1:1:1), randomized comparative effectiveness 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone intravitreal implant 0.7mg | Active comparator | Drug: Dexamethasone intravitreal implant 0.7 mgParticipants 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; |
| Intravitreal methotrexate 400µg in 0.1mL | Active comparator | Drug: Intravitreal Methotrexate 400 µgParticipants 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. |
| Intravitreal ranibizumab 0.5mg in 0.05mL | Active comparator | Drug: Intravitreal Ranibizumab 0.5 mgParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient level inclusion criterion
- 18 years of age or older;
- Eye level inclusion criteria - at least one eye must meet all of the following conditions
- Inactive or minimally active non-infectious anterior, intermediate, posterior or panuveitis, as defined by the Standardization of Uveitis Nomenclature (SUN) Working Group criteria as ≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze grade and no active retinal/choroidal lesions for a minimum of 4 weeks;
- Macular edema (ME) defined as the presence of macular thickness greater than the normal range for the OCT machine being used (see cut points below), regardless of the presence of cysts, following an intravitreal corticosteroid injection (≥ 4 weeks following intravitreal triamcinolone injection or ≥ 12 weeks following intravitreal dexamethasone implant injection);
Key exclusion criteria (21 listed)
- Patient level exclusion criteria
- History of infectious uveitis in either eye;
- History of infectious scleritis of any type in either eye (Note: History of noninfectious scleritis that has been active in past 12 months is an eye-level exclusion -see #13 below);
- History of keratitis (with the exception of keratitis due to dry eye) in either eye;
- History of central serous retinopathy in either eye;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone intravitreal implant 0.7 mgAlso: OzurdexStandard preparation as described for intravitreal injections. | Drug | Dexamethasone intravitreal implant 0.7mg |
| Intravitreal Methotrexate 400 µgIntravitreal 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 methotrexate 400µg in 0.1mL |
| Intravitreal Ranibizumab 0.5 mgAlso: LucentisIntravitreal 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. | Drug | Intravitreal ranibizumab 0.5mg in 0.05mL |
Primary outcome
Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks
Time frame: At 12-week visit
The primary outcome is the change in central subfield thickness from baseline to 12 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. The proportion of baseline subfield thickness is estimated by a mixed effect model that includes time points for baseline, week 4, week 8, and week 12 and the treatment group. The treatment effect is the interaction (product) of time point and treatment. Contrasts of the model parameter estimates were used to calculate the change from baseline to week 12 and the comparison between treatment groups. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases (improvement).The OCT outcomes were measured by masked readers. The 12-week visit was chosen as the time to assess the primary outcome because of the ranibizumab treatment schedule and the peak effect time for dexamethasone
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37318415Multicenter Uveitis Steroid Treatment Trial (MUST) Research Group, Writing Committee:; Acharya NR, Vitale AT, Sugar EA, Holbrook JT, Burke AE, Thorne JE, Altaweel MM, Kempen JH, Jabs DA. Intravitreal Therapy for Uveitic Macular Edema-Ranibizumab versus Methotrexate versus the Dexamethasone Implant: The MERIT Trial Results. Ophthalmology. 2023 Sep;130(9):914-923. doi: 10.1016/j.ophtha.2023.04.011. Epub 2023 Jun 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas A Jabs, MD, MBA study chair
Center for Clinical Trials and Evidence Synthesis, JHU, Baltimore, MD
33 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone intravitreal implant 0.7 mg, Intravitreal Methotrexate 400 µg and Intravitreal Ranibizumab 0.5 mg in people with Uveitis and Macular Edema, run by JHSPH Center for Clinical Trials at 33 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, United Kingdom, India, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Baseline Central Subfield Thickness Observed at 12 Weeks (time frame: At 12-week visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02623426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.