Efficacy and safety of Methotrexate injections into the eye for inflammatory diseases of the eye.

Phase 2

Completed

• Conditions: Visual loss due to macular oedema secondary to uveitis; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12610001004055
• Lead Sponsor: Royal Victorian Eye and Ear Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

(i)Over 18 years of age
(ii)Active non-infectious intermediate, posterior or panuveitis, defined as vitreal cell, vitreal haze, inflammatory debris and/or active chorioretinal lesions of a degree for which systemic or intravitreal corticosteroid treatment is indicated that has either been unresponsive to standard treatment (including intravitreal triamcinolone) or where further local steroid treatment is relatively contraindicated (e.g. pre-existing glaucoma or steroid responder), OR
(iii)Uveitic cystoid macular oedema in one or both eyes that has either been unresponsive to standard treatment (including intravitreal triamcinolone) or where further local steroid treatment is relatively contraindicated (e.g. pre-existing glaucoma or steroid responder)
(iv)Best corrected visual acuity in the affected eye(s) = 6/12 or worse
(v)Subjects must have signed the informed consent form

Exclusion Criteria

(i)Loss of vision due to other causes (e.g. myopic macular degeneration)
(ii)Significant macular ischaemia (as determined on Fundus Fluorescein angiography)
(iii)Known allergies to methotrexate
(iv)Active ocular infection (eg. Conjunctivitis, keratitis)
(v)Intercurrent severe disease such as septicaemia
(vi)History of other systemic disease(s) that, in the opinion of the investigator, may render the subject at a high risk for treatment complications
(vii)Any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities)
(viii)Unwillingness or inability to give informed consent
(ix)Under age 18
(x)Pregnant or lactating women
(xi)Premenopausal women of child bearing potential not using adequate contraception. Adequate contraception includes the use of one or more of the following: surgical sterilisation (tubal ligation), hormonal sterilisation (implant, patch or oral), and double barrier methods (any double combination of: an intrauterine device (IUD), condom with spermicidal gel, diaphragm, sponge, cervical cap). Reliable contraception must be maintained throughout the study and for 30 days after methotrexate discontinuation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best corrected Snellan Visual Acuity at baseline (pre treatment) and at 3 monthly timepoints over a maximum of 12 months[Every 6 weeks post injection for 12 months]

Secondary Outcome Measures

Name	Time	Method
Central Macular thickness as measured on OCT at baseline and at 3 monthly intervals over 12 months[Every 6 weeks post injection for 12 months];Uveitic activity as per the Standardised Uveitis Nomenclature (SUN) criteria[Every 6 weeks post injection for 12 months]