Investigation into optimal steroid treatment for subjects with sight threatening uveitis

Phase 1

• Conditions: veitic macular oedema; MedDRA version: 20.0Level: LLTClassification code 10002709Term: Anterior uveitisSystem Organ Class: 100000014995; MedDRA version: 20.0Level: LLTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 100000161411; MedDRA version: 20.0Level: LLTClassification code 10033687Term: PanuveitisSystem Organ Class: 100000014975; MedDRA version: 20.0Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 100000015065; MedDRA version: 20.0Level: PTClassification code 10058202Term: Cystoid macular oedemaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-000304-29-GB
• Lead Sponsor: MUST Coordinating Centre, John Hopkins Bloomberg School of Public Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-15
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 267

Inclusion Criteria

Patient level inclusion criterion:
1. 18 years of age or older;
Eye level inclusion criteria - at least one eye must meet all of the following conditions
2. Non-infectious anterior, intermediate, posterior or panuveitis; either active or inactive uveitis is acceptable;
3. Macular edema (ME) defined as the presence of central subfield macular thickness
greater than the normal range for the OCT machine being used (>300 µm for Zeiss
Cirrus/Topcon 3DOCT or >320 µm for Heidelberg Spectralis), regardless of the
presence of cysts, as assessed by study ophthalmologist;
4. Best corrected visual acuity (BCVA) 5/200 or better;
5. Baseline intraocular pressure > 5 mm Hg and = 21 mm Hg (current use of 3 or fewer intraocular pressure-lowering medications and/or prior glaucoma surgery are acceptable – note that combination medications, i.e., Cosopt, count as 2 IOP lowering medications);
6. Baseline fluorescein angiogram that is gradable for degree of leakage in the central subfield
7.Pupillary dilation sufficient to allow OCT testing.

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

Patient level exclusion criteria:
1. History of infectious endophthalmitis or 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 #11 below.)
3. History of keratitis (with the exception of keratitis due to dry eye)of any type in either eye;
4.History of central serous retinopathy in either eye;
5. 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;
6. Use of oral acetazolamide or other systemic carbonic anhydrase inhibitor at baseline;
7. 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 that if patient is off of oral prednisone at baseline (P01 visit), dose stability requirement for past 4 weeks does not apply);
8. Systemic immunosuppressive drug therapy that has not been stable for at least 4 weeks;
9. Known allergy or hypersensitivity to any component of the study drugs;
Eye level exclusion criteria - at least one eye that meets all inclusion criteria cannot have any of the following conditions:
10. 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);
11. Media opacity causing inability to assess fundus or perform OCT;
12. 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);
13. 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)81;
14. Torn or ruptured posterior lens capsule
15. Presence of silicone oil;
16. Periocular or intravitreal corticosteroid injection in past 8 weeks;
17. Injection of dexamethasone intravitreal implant in past 12 weeks;
18. Placement of fluocinolone acetonide implant (Retisert) in past 3 years;

Study & Design

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