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Trial registered on ANZCTR


Registration number
ACTRN12616000012471
Ethics application status
Approved
Date submitted
11/12/2015
Date registered
12/01/2016
Date last updated
12/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and efficacy of ziv Aflibercept compounding in refractory diabetic macular oedema
Scientific title
Safety and efficacy of ziv Aflibercept compounding in refractory diabetic macular oedema
Secondary ID [1] 288136 0
ziv A 1
Universal Trial Number (UTN)
Trial acronym
zADMO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic macular oedema 297014 0
Condition category
Condition code
Eye 297263 297263 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 297285 297285 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravitreal injection of ziv Aflibercept 2mg monthly
For three months then as required monthly depending on clinical indications of retinal fluid at the clinical discretion of ophthalmologist
Intervention code [1] 293446 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296852 0
Collection of adverse events
Questioned and examined by ophthalmologist
(discomfort, redness, inflammation assessed by self report, OCT retinal scan and retina thickness documented, Log MAR vision chart assessed and negative change will be be documented at each clinical visit)
Clinical examination on slit lamp by Ophthalmologist (inflammation and ocular changes noted)
(Systemic adverse symptoms reported ie Stroke and cardiac events will be recorded at each clinical visit)
Timepoint [1] 296852 0
three months
Secondary outcome [1] 319528 0
Clinical outcomes of vision from Log MAR vision tested.
Improvements will be assessed collated for comparison to published data.
Timepoint [1] 319528 0
3 months
Secondary outcome [2] 319529 0
Retinal thickness reduction from OCT retinal scan noted and collated for comparison to published data.
Timepoint [2] 319529 0
3 months

Eligibility
Key inclusion criteria
Inclusion Criteria:
Ability to provide informed consent and complete study assessments
Age 18 years or older
Diabetic macular oedema not responding to compounded Avastin (Bevacizumab or ranibizumab)
Best corrected baseline visual acuity between 6/6 to 6/60 on ETDRS chart
Presence of sub retinal fluid or cystic intraretinal oedema on spectral domain OCT (SD-OCT) [Spectralis]
Documentation of the presence of sub retinal fluid or cystoid oedema less than 42 days since last treatment with an antiVegf agent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Recent CVA or MI

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/01/2016
Actual
Date of last participant enrolment
Anticipated
1/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 7411 0
New Zealand
State/province [1] 7411 0
Auckland

Funding & Sponsors
Funding source category [1] 292544 0
Self funded/Unfunded
Name [1] 292544 0
Country [1] 292544 0
Primary sponsor type
Individual
Name
Dr Andrew Riley
Address
Eye Department
Greenlane clinical centre
214 Green Lane West
Epsom
Auckland 1051
New Zealand
Country
New Zealand
Secondary sponsor category [1] 291261 0
None
Name [1] 291261 0
Address [1] 291261 0
Country [1] 291261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294020 0
Health and Disability Ethics Committees
Ethics committee address [1] 294020 0
Ministry of Health Freyberg Building 20 Aitken Street PO Box 5013 Wellington 6011
Ethics committee country [1] 294020 0
New Zealand
Date submitted for ethics approval [1] 294020 0
01/12/2015
Approval date [1] 294020 0
11/12/2015
Ethics approval number [1] 294020 0
15/NTA/195

Summary
Brief summary
This study is designed to specifically target on patients with diabetic macular oedema who are poorly responsive to current anti-VEGF therapy (bevacizumab or ranibiznumab), and evaluate whether changing the therapeutic agent to intravitreal ziv aflibercept injection would lead to improved functional and anatomical outcomes. The 48 week treatment duration is appropriate for a pilot study.
The hypothesis of this study is that compounded intravitreal ziv Aflibercept injection may be effective in causing resolution of persistent sub or intraretinal fluid despite previous treatment with bevacizumab or ranibizumab by counteracting the effect of both VEGF-A and placental growth factor, with increased binding affinity. At the very least, being as effective as previous treatment but with fewer treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62158 0
Dr Andrew Riley
Address 62158 0
Eye Department
Greenlane clinical centre
214 Green Lane West
Epsom
Auckland 1051
New Zealand
Country 62158 0
New Zealand
Phone 62158 0
+64 93670000
Fax 62158 0
+64 9 5209688
Email 62158 0
[email protected]
Contact person for public queries
Name 62159 0
Andrew Riley
Address 62159 0
Eye Department
Greenlane clinical centre
214 Green Lane West
Epsom
Auckland 1051
New Zealand
Country 62159 0
New Zealand
Phone 62159 0
+64 93670000
Fax 62159 0
+64 95209688
Email 62159 0
[email protected]
Contact person for scientific queries
Name 62160 0
Andrew Riley
Address 62160 0
Eye Department
Greenlane clinical centre
214 Green Lane West
Epsom
Auckland 1051
New Zealand
Country 62160 0
New Zealand
Phone 62160 0
+64 93670000
Fax 62160 0
+64 95209688
Email 62160 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.