Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001004055
Ethics application status
Approved
Date submitted
5/11/2009
Date registered
17/11/2010
Date last updated
7/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of Methotrexate injections into the eye for inflammatory diseases of the eye.
Scientific title
Prospective, Phase II , non-randomised interventional case series of the safety and efficacy of the use of intra-vitreal methotrexate in the treatment of macular oedema secondary to uveitis
Secondary ID [1] 253110 0
HREC 09/907H
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Visual loss due to macular oedema secondary to uveitis 252128 0
Condition category
Condition code
Eye 252336 252336 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single Intraviteal methotrexate injection 400mcg/0.1ml; repeated monthly as required
Intervention code [1] 241507 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253208 0
Best corrected Snellan Visual Acuity at baseline (pre treatment) and at 3 monthly timepoints over a maximum of 12 months
Timepoint [1] 253208 0
Every 6 weeks post injection for 12 months
Secondary outcome [1] 262139 0
Central Macular thickness as measured on OCT at baseline and at 3 monthly intervals over 12 months
Timepoint [1] 262139 0
Every 6 weeks post injection for 12 months
Secondary outcome [2] 262140 0
Uveitic activity as per the Standardised Uveitis Nomenclature (SUN) criteria
Timepoint [2] 262140 0
Every 6 weeks post injection for 12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants would be recruited from subjects known to have active non-infectious intermediate, posterior or panuveitis; or uveitic macular oedema involving the fovea in one or both eyes. These patients will be outpatients recruited from the Ocular Immunology Clinic of the Royal Victorian Eye and Ear Hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/11/2009
Actual
18/11/2009
Date of last participant enrolment
Anticipated
31/12/2011
Actual
15/09/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 243978 0
Hospital
Name [1] 243978 0
Royal Victorian Eye and Ear Hospital
Country [1] 243978 0
Australia
Primary sponsor type
Hospital
Name
Royal Victorian Eye and Ear Hospital
Address
32 Gisborne Street
East Melbourne,
Victoria 3002
Country
Australia
Secondary sponsor category [1] 251331 0
University
Name [1] 251331 0
Centre for Eye Research, University of Melbourne
Address [1] 251331 0
32 Gisborne Street
East Melbourne,
Victoria 3002
Country [1] 251331 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244088 0
Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 244088 0
Ethics committee country [1] 244088 0
Australia
Date submitted for ethics approval [1] 244088 0
Approval date [1] 244088 0
02/09/2009
Ethics approval number [1] 244088 0
09/907H

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30466 0
Dr Dr Lyndell Lim
Address 30466 0
Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Locked Bag 8, East Melbourne, Victoria, 8002
Country 30466 0
Australia
Phone 30466 0
+61399298759
Fax 30466 0
+61399298030
Email 30466 0
[email protected]
Contact person for public queries
Name 13713 0
Lyndell Lim
Address 13713 0
Centre for Eye Research Australia,
Royal Victorian Eye and Ear Hospital,
Locked Bag 8,
East Melbourne,
Victoria, 8002
Country 13713 0
Australia
Phone 13713 0
+613 9929 8759
Fax 13713 0
+613 9929 8030
Email 13713 0
[email protected]
Contact person for scientific queries
Name 4641 0
Lyndell Lim
Address 4641 0
Centre for Eye Research Australia,
Royal Victorian Eye and Ear Hospital,
Locked Bag 8,
East Melbourne,
Victoria, 8002
Country 4641 0
Australia
Phone 4641 0
+613 9929 8759
Fax 4641 0
+613 9929 8030
Email 4641 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.