Macular Edema Ranibizumab v. Intravitreal anti-inflammatory Therapy (MERIT) Trial

Phase 1

• Conditions: veitic macular oedema; MedDRA version: 20.1Level: LLTClassification code 10002709Term: Anterior uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 22.1Level: LLTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.1Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 100000004862; MedDRA version: 20.0Level: LLTClassification code 10033687Term: PanuveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.1Level: PTClassification code 10058202Term: Cystoid macular oedemaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-003243-37-GB
• Lead Sponsor: MUST Coordinating Centre, John Hopkins Bloomberg School of Public Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-12
• Last Update Posted: 14 December 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1.18 years of age or older;

Eye level inclusion criteria - at least one eye must meet all of the following conditions

2.Inactive or minimally active non-infectious anterior, intermediate, posterior or panuveitis, as defined by SUN132 criteria as = 0.5+ anterior chamber cells, = 0.5+ vitreous haze grade and no active retinal/choroidal lesions for a minimum of 4 weeks;

3.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 3DOCT

4.Baseline fluorescein angiogram that, as assessed by the study ophthalmologist, is gradable for degree of leakage in the central subfield;

5.Best corrected visual acuity (BCVA) 5/200 or better;

6.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);

7.Media clarity and pupillary dilation sufficient to allow OCT testing and assessment of the fundus.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.History of infectious uveitis in either eye;

2.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);

3.History of keratitis (with the exception of keratitis due to dry eye) in either eye;

4.History of central serous retinopathy in either eye;

5.Active infectious conjunctivitis in either eye;

6.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);

7.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);

8.Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;

9.Known allergy or hypersensitivity to any component of the study drugs;

10.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

11.History of infectious endophthalmitis;

12.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);

13.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);

14.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);

15.Torn or ruptured posterior lens capsule

16.Presence of silicone oil;

17. Ozurdex administered in past 12 weeks;

18.Anti-VEGF agent, intravitreal methotrexate, or intravitreal/periocular corticosteroid administered in past 4 weeks;

19.Fluocinolone acetonide implant (Retisert) placed in past 3 years.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified