MERIT Trial
Research type
Research Study
Full title
Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial
IRAS ID
186573
Contact name
Denniston Alastair
Contact email
Sponsor organisation
MUST Coordinating Centre, John Hopkins Bloomberg School of Public Health
Eudract number
2017-003243-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 12 days
Research summary
Macular oedema is swelling of the retina at the back of the eye. It can cause vision loss and is a common complication in patients who have the eye condition uveitis (inflammation inside the eye). The standard treatments are to inject corticosteroid drugs next to the eye or directly into the eye. While corticosteroid injections may reduce macular oedema 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. Intravitreal dexamethasone implant (Ozurdex®, Allergan, Irvine, CA) has recently been approved for uveitic macular oedema in patients with non-infectious uveitis. It has a longer duration of action, requiring less frequent reinjection.
Recent pilot studies have shown intravitreal methotrexate and intravitreal ranibizumab (Lucentis®, Genentech Inc., San Francisco, CA) to be promising treatments for uveitic macular oedema. In addition to being effective, intravitreal methotrexate and ranibizumab potentially may have less ocular side effects than corticosteroids, particularly less intraocular pressure elevation.
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. Subjects will be randomised to one of the three treatments and followed for a period of 6 months to document resolution of macular oedema, improvement in vision, complications (cataract and raised intraocular pressure) and cost effectiveness.REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0476
Date of REC Opinion
28 Sep 2017
REC opinion
Favourable Opinion