Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001310853
Ethics application status
Approved
Date submitted
17/12/2012
Date registered
18/12/2012
Date last updated
24/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of Intravitreal Aflibercept Treatment on Exudative Age-related Macular Degeneration Patients
Scientific title
Obervational Study on the Effectiveness of Intravitreal Aflibercept in Exudative Age-related Macular Degeneration Patients
Secondary ID [1] 281689 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exudative age-related macular degeneration 287978 0
Condition category
Condition code
Eye 288361 288361 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study is to evaluate the effectiveness of individualized intravitreal aflibercept in the treatment of exudative age-related macular degeneration (AMD) in routine clinical practice. Patients with previously or currently being treated with, or initiating treatment with intravitreal aflibercept for exudative AMD will be observed up to 24 months. Best corrected visual acuity and optical coherence tomography measurements will be collected at each visit if data are available.
Intervention code [1] 286226 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288528 0
Best-corrected visual acuity will be tested by snellen visual acuity chart or Early Treatment Diabetic Retinopathy Study (ETDRS) eye Charts. The patients will be asked to read letters from the top of the chart to the bottom, and the visual acuity is scored by how many letters could be correctly identified.
Timepoint [1] 288528 0
2 year
Primary outcome [2] 288529 0
Macular thickness will be measured by optical coherence tomography
Timepoint [2] 288529 0
2 year
Secondary outcome [1] 300396 0
All adverse events,including study treatment related (Including eye pain, floater, irritation and haemorrhage, etc.) or unrelated (including stroke, heart attack and pneumonia, etc), will be recorded during the 24 months’ follow up.
Timepoint [1] 300396 0
2 years

Eligibility
Key inclusion criteria
1) Previously or currently being treated with, or initiating treatment, with aflibercept for exudative AMD; and
2) Ability to provide informed consent and complete study assessments
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or lactation
Premenopausal women not using contraception
Prior anti-VEGF injection in the study eye within 28 days of baseline
Prior treatment with photo dynamic therapy (PDT) within 90 days of baseline and more than 6 prior PDT treatments
Significant subretinal fibrosis or atrophy
Prior treatment with triamcinolone in the study eye within 6 months of baseline
Intraocular surgery in the study eye within 2 months of baseline
Simultaneous participation in a study that includes administration of any investigational drug or procedures.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2013
Actual
31/01/2013
Date of last participant enrolment
Anticipated
Actual
28/11/2014
Date of last data collection
Anticipated
Actual
28/02/2016
Sample size
Target
200
Accrual to date
Final
184
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 323 0
Sydney Retina Clinic & Day Surgery - Sydney
Recruitment postcode(s) [1] 6128 0
2000 - Parliament House

Funding & Sponsors
Funding source category [1] 286480 0
Hospital
Name [1] 286480 0
Sydney Retina Clinic and Day Surgery
Country [1] 286480 0
Australia
Primary sponsor type
Hospital
Name
Sydney Retina Clinic and Day Surgery
Address
Level 13, 187 Macquarie Street, Sydney, NSW 2000 Australia
Country
Australia
Secondary sponsor category [1] 285270 0
None
Name [1] 285270 0
Address [1] 285270 0
Country [1] 285270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288557 0
Bellberry Ethics Committee
Ethics committee address [1] 288557 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 288557 0
Australia
Date submitted for ethics approval [1] 288557 0
12/12/2012
Approval date [1] 288557 0
30/01/2013
Ethics approval number [1] 288557 0
2012-11-1204

Summary
Brief summary
This study is designed as an observational study on patients being treated with 2.0mg intravitreal aflibercept for exudative age-related macular degeneration in a tertiary retinal clinic. This study does not direct therapy or recommend any treatment other than that the patients be treated in accordance with the aflibercept local product label. Efficacy of the individualized intravitreal aflibercept will be assessed by the changes in bested corrected visual acuity and macular thickness measured by optical coherence tomography, which are the routine eye examinations for monitoring this type of disease. Timing of actual patients visits is at the discretion of the treating physician.
The study will be conducted for 30 months with a 6-month recruitment period and 24-month follow up period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36670 0
Dr Andrew Chang
Address 36670 0
Level 13, 187 Macquarie Street, Sydney, NSW 2000 Australia
Country 36670 0
Australia
Phone 36670 0
+61 2 9221 3755
Fax 36670 0
Email 36670 0
[email protected]
Contact person for public queries
Name 36671 0
Dr Andrew Chang
Address 36671 0
Level 13, 187 Macquarie Street, Sydney, NSW 2000 Australia
Country 36671 0
Australia
Phone 36671 0
+61 2 9221 3755
Fax 36671 0
Email 36671 0
[email protected]
Contact person for scientific queries
Name 36672 0
Dr Andrew Chang
Address 36672 0
Level 13, 187 Macquarie Street, Sydney, NSW 2000 Australia
Country 36672 0
Australia
Phone 36672 0
+61 2 9221 3755
Fax 36672 0
Email 36672 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.